Elizabeth Mechcatie

SILVER SPRING, MD. — The majority of a federal advisory panel agreed that the data on a recombinant bivalent human papillomavirus vaccine indicate that the vaccine is safe and effective in preventing cervical cancer and certain precancerous or dysplastic lesions caused by HPV types 16 and 18 in girls and women aged 10–25 years.

The FDA's Vaccines and Related Biological Products Advisory Committee voted 12–1 that the data on the GlaxoSmithKline Biologicals human papillomavirus bivalent (types 16 and 18) vaccine, recombinant, supported the efficacy of the vaccine for preventing HPV 16/18-related cervical cancer, cervical intraepithelial neoplasia (CIN) 2+, adenocarcinoma in situ (AIS), and CIN1+ in girls and women aged 15–25 years.

In a separate vote, the panel again voted 12-1 that the results of an immunogenicity bridging study from the United Kingdom, which compared immune responses to the vaccine in recipients aged 10–14 years with those of older recipients, supported effectiveness of this same claim in girls aged 10–14 years. There were no efficacy data in the younger age group, but immune responses for HPV 16/18 in the younger girls were similar to those in the older group.

If approved, GSK plans to market the vaccine as Cervarix. GSK has proposed that Cervarix be licensed for prevention of cervical cancer (squamous cell cancer and adenocarcinoma) and protection against precancerous or dysplastic lesions and persistent/incident infections caused by HPV types 16 and 18, in girls and women aged 10–25 years. It is administered in a three-dose schedule at 0, 1, and 6 months.

The majority of the panel also voted that the data supported the safety of the vaccine in girls and women aged 10–25 years but recommended that safety issues, which included spontaneous abortions, be studied further after licensure. In the pivotal study, there was a higher number of spontaneous abortions around the time of vaccination than in the comparison group.

GSK, which has a Cervarix pregnancy registry in the United Kingdom, has announced plans to combine that with a U.S. registry, pending FDA approval. The company has also announced plans to conduct a postmarketing safety study.

There were more musculoskeletal and neuroinflammatory events with potential autoimmune causes—although rare—among almost 30,000 Cervarix recipients, compared with controls. The three most common adverse events associated with the vaccine were headache, injection site pain, and fever.

The FDA usually follows the recommendations of its advisory panels. HPV 16 and 18 cause most cervical cancers in the United States. The vaccine, approved in 2007 in Australia, is now licensed in 98 countries.

Merck's quadrivalent HPV vaccine, Gardasil (human papillomavirus [types 6, 11, 16, 18] quadrivalent vaccine, recombinant), is approved for girls and women aged 9–26 years, for preventing cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18 as well as associated precursor lesions and genital warts caused by HPV types 6 and 11.

SILVER SPRING, MD. — The majority of a federal advisory panel agreed that the data on a recombinant bivalent human papillomavirus vaccine indicate that the vaccine is safe and effective in preventing cervical cancer and certain precancerous or dysplastic lesions caused by HPV types 16 and 18 in girls and women aged 10–25 years.

The FDA's Vaccines and Related Biological Products Advisory Committee voted 12–1 that the data on the GlaxoSmithKline Biologicals human papillomavirus bivalent (types 16 and 18) vaccine, recombinant, supported the efficacy of the vaccine for preventing HPV 16/18-related cervical cancer, cervical intraepithelial neoplasia (CIN) 2+, adenocarcinoma in situ (AIS), and CIN1+ in girls and women aged 15–25 years.

In a separate vote, the panel again voted 12-1 that the results of an immunogenicity bridging study from the United Kingdom, which compared immune responses to the vaccine in recipients aged 10–14 years with those of older recipients, supported effectiveness of this same claim in girls aged 10–14 years. There were no efficacy data in the younger age group, but immune responses for HPV 16/18 in the younger girls were similar to those in the older group.

If approved, GSK plans to market the vaccine as Cervarix. GSK has proposed that Cervarix be licensed for prevention of cervical cancer (squamous cell cancer and adenocarcinoma) and protection against precancerous or dysplastic lesions and persistent/incident infections caused by HPV types 16 and 18, in girls and women aged 10–25 years. It is administered in a three-dose schedule at 0, 1, and 6 months.

The majority of the panel also voted that the data supported the safety of the vaccine in girls and women aged 10–25 years but recommended that safety issues, which included spontaneous abortions, be studied further after licensure. In the pivotal study, there was a higher number of spontaneous abortions around the time of vaccination than in the comparison group.

GSK, which has a Cervarix pregnancy registry in the United Kingdom, has announced plans to combine that with a U.S. registry, pending FDA approval. The company has also announced plans to conduct a postmarketing safety study.

There were more musculoskeletal and neuroinflammatory events with potential autoimmune causes—although rare—among almost 30,000 Cervarix recipients, compared with controls. The three most common adverse events associated with the vaccine were headache, injection site pain, and fever.

The FDA usually follows the recommendations of its advisory panels. HPV 16 and 18 cause most cervical cancers in the United States. The vaccine, approved in 2007 in Australia, is now licensed in 98 countries.

Merck's quadrivalent HPV vaccine, Gardasil (human papillomavirus [types 6, 11, 16, 18] quadrivalent vaccine, recombinant), is approved for girls and women aged 9–26 years, for preventing cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18 as well as associated precursor lesions and genital warts caused by HPV types 6 and 11.

SILVER SPRING, MD. — The majority of a federal advisory panel agreed that the data on a recombinant bivalent human papillomavirus vaccine indicate that the vaccine is safe and effective in preventing cervical cancer and certain precancerous or dysplastic lesions caused by HPV types 16 and 18 in girls and women aged 10–25 years.

The FDA's Vaccines and Related Biological Products Advisory Committee voted 12–1 that the data on the GlaxoSmithKline Biologicals human papillomavirus bivalent (types 16 and 18) vaccine, recombinant, supported the efficacy of the vaccine for preventing HPV 16/18-related cervical cancer, cervical intraepithelial neoplasia (CIN) 2+, adenocarcinoma in situ (AIS), and CIN1+ in girls and women aged 15–25 years.

In a separate vote, the panel again voted 12-1 that the results of an immunogenicity bridging study from the United Kingdom, which compared immune responses to the vaccine in recipients aged 10–14 years with those of older recipients, supported effectiveness of this same claim in girls aged 10–14 years. There were no efficacy data in the younger age group, but immune responses for HPV 16/18 in the younger girls were similar to those in the older group.

If approved, GSK plans to market the vaccine as Cervarix. GSK has proposed that Cervarix be licensed for prevention of cervical cancer (squamous cell cancer and adenocarcinoma) and protection against precancerous or dysplastic lesions and persistent/incident infections caused by HPV types 16 and 18, in girls and women aged 10–25 years. It is administered in a three-dose schedule at 0, 1, and 6 months.

The majority of the panel also voted that the data supported the safety of the vaccine in girls and women aged 10–25 years but recommended that safety issues, which included spontaneous abortions, be studied further after licensure. In the pivotal study, there was a higher number of spontaneous abortions around the time of vaccination than in the comparison group.

GSK, which has a Cervarix pregnancy registry in the United Kingdom, has announced plans to combine that with a U.S. registry, pending FDA approval. The company has also announced plans to conduct a postmarketing safety study.

There were more musculoskeletal and neuroinflammatory events with potential autoimmune causes—although rare—among almost 30,000 Cervarix recipients, compared with controls. The three most common adverse events associated with the vaccine were headache, injection site pain, and fever.

The FDA usually follows the recommendations of its advisory panels. HPV 16 and 18 cause most cervical cancers in the United States. The vaccine, approved in 2007 in Australia, is now licensed in 98 countries.

Merck's quadrivalent HPV vaccine, Gardasil (human papillomavirus [types 6, 11, 16, 18] quadrivalent vaccine, recombinant), is approved for girls and women aged 9–26 years, for preventing cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18 as well as associated precursor lesions and genital warts caused by HPV types 6 and 11.

Data detailing a recent drop in the age-adjusted death rate and other positive trends regarding life expectancy and deaths in the United States were released in a report by the Centers for Disease Control and Prevention.

The report, by the CDC's National Center for Health Statistics, provided preliminary data on deaths, death rates, life expectancy, leading causes of death, and infant mortality in the United States in 2007, based on information from almost 90% of the nation's death certificates.

In 2007, the life expectancy was 77.9 years, an increase from 77.7 years in 2006, which “represents a continuation of a trend,” according to a statement by the CDC. Life expectancy has increased by 1.4 years since 1997, when it was 76.5 years. Life expectancy at birth also rose, to 77.9 years, an increase of 0.2 years from 2006.

The age-adjusted death rate dropped to 760.3 deaths/100,000 population, from 776.5 deaths/100,000 population in 2006. This is half of what the rate was in 1947: 1,532/100,000 population.

There was a significant drop in age-adjusted death rates for 8 of the 15 leading causes of death, including heart disease (a 4.7% drop from 2007), cancer (1.8%), cerebrovascular diseases (4.6%), accidents (5%), diabetes mellitus (3.9%), influenza and pneumonia (8.4%), essential hypertension and hypertensive renal disease (2.7%), and homicide (6.5%), the CDC reported. Another positive trend was life expectancy for black men, which reached 70 years for the first time.

However, from 2006 to 2007, there were no significant changes in the age-adjusted death rates for Alzheimer's disease, septicemia, suicide, chronic liver disease and cirrhosis, Parkinson's disease, and nephritis, nephrotic syndrome, and nephrosis.

But the death rate for chronic lower-respiratory diseases, the fourth leading cause of death, increased by 1.7% in 2007 from 2006.

Mortality from HIV/AIDS dropped by 10% between 2006 and 2007, “the biggest 1-year decline” since 1998, according to the CDC. In 2007, approximately 11,000 people died of HIV/AIDS, which remains the sixth-leading cause of death among people aged 25-44 years.

Infant mortality in 2007 was 6.77 infant deaths/1,000 live births, which is a statistically insignificant increase (1.2%) from 2006. In 2007, the leading cause of infant deaths was birth defects, followed by preterm birth and low birth weight, and the third leading cause, sudden infant death syndrome.

The full report, titled “Deaths: Preliminary Data for 2007,” is available at www.cdc.gov/nchs

Data detailing a recent drop in the age-adjusted death rate and other positive trends regarding life expectancy and deaths in the United States were released in a report by the Centers for Disease Control and Prevention.

The report, by the CDC's National Center for Health Statistics, provided preliminary data on deaths, death rates, life expectancy, leading causes of death, and infant mortality in the United States in 2007, based on information from almost 90% of the nation's death certificates.

In 2007, the life expectancy was 77.9 years, an increase from 77.7 years in 2006, which “represents a continuation of a trend,” according to a statement by the CDC. Life expectancy has increased by 1.4 years since 1997, when it was 76.5 years. Life expectancy at birth also rose, to 77.9 years, an increase of 0.2 years from 2006.

The age-adjusted death rate dropped to 760.3 deaths/100,000 population, from 776.5 deaths/100,000 population in 2006. This is half of what the rate was in 1947: 1,532/100,000 population.

There was a significant drop in age-adjusted death rates for 8 of the 15 leading causes of death, including heart disease (a 4.7% drop from 2007), cancer (1.8%), cerebrovascular diseases (4.6%), accidents (5%), diabetes mellitus (3.9%), influenza and pneumonia (8.4%), essential hypertension and hypertensive renal disease (2.7%), and homicide (6.5%), the CDC reported. Another positive trend was life expectancy for black men, which reached 70 years for the first time.

However, from 2006 to 2007, there were no significant changes in the age-adjusted death rates for Alzheimer's disease, septicemia, suicide, chronic liver disease and cirrhosis, Parkinson's disease, and nephritis, nephrotic syndrome, and nephrosis.

But the death rate for chronic lower-respiratory diseases, the fourth leading cause of death, increased by 1.7% in 2007 from 2006.

Mortality from HIV/AIDS dropped by 10% between 2006 and 2007, “the biggest 1-year decline” since 1998, according to the CDC. In 2007, approximately 11,000 people died of HIV/AIDS, which remains the sixth-leading cause of death among people aged 25-44 years.

Infant mortality in 2007 was 6.77 infant deaths/1,000 live births, which is a statistically insignificant increase (1.2%) from 2006. In 2007, the leading cause of infant deaths was birth defects, followed by preterm birth and low birth weight, and the third leading cause, sudden infant death syndrome.

The full report, titled “Deaths: Preliminary Data for 2007,” is available at www.cdc.gov/nchs

Data detailing a recent drop in the age-adjusted death rate and other positive trends regarding life expectancy and deaths in the United States were released in a report by the Centers for Disease Control and Prevention.

The report, by the CDC's National Center for Health Statistics, provided preliminary data on deaths, death rates, life expectancy, leading causes of death, and infant mortality in the United States in 2007, based on information from almost 90% of the nation's death certificates.

In 2007, the life expectancy was 77.9 years, an increase from 77.7 years in 2006, which “represents a continuation of a trend,” according to a statement by the CDC. Life expectancy has increased by 1.4 years since 1997, when it was 76.5 years. Life expectancy at birth also rose, to 77.9 years, an increase of 0.2 years from 2006.

The age-adjusted death rate dropped to 760.3 deaths/100,000 population, from 776.5 deaths/100,000 population in 2006. This is half of what the rate was in 1947: 1,532/100,000 population.

There was a significant drop in age-adjusted death rates for 8 of the 15 leading causes of death, including heart disease (a 4.7% drop from 2007), cancer (1.8%), cerebrovascular diseases (4.6%), accidents (5%), diabetes mellitus (3.9%), influenza and pneumonia (8.4%), essential hypertension and hypertensive renal disease (2.7%), and homicide (6.5%), the CDC reported. Another positive trend was life expectancy for black men, which reached 70 years for the first time.

However, from 2006 to 2007, there were no significant changes in the age-adjusted death rates for Alzheimer's disease, septicemia, suicide, chronic liver disease and cirrhosis, Parkinson's disease, and nephritis, nephrotic syndrome, and nephrosis.

But the death rate for chronic lower-respiratory diseases, the fourth leading cause of death, increased by 1.7% in 2007 from 2006.

Mortality from HIV/AIDS dropped by 10% between 2006 and 2007, “the biggest 1-year decline” since 1998, according to the CDC. In 2007, approximately 11,000 people died of HIV/AIDS, which remains the sixth-leading cause of death among people aged 25-44 years.

Infant mortality in 2007 was 6.77 infant deaths/1,000 live births, which is a statistically insignificant increase (1.2%) from 2006. In 2007, the leading cause of infant deaths was birth defects, followed by preterm birth and low birth weight, and the third leading cause, sudden infant death syndrome.

The full report, titled “Deaths: Preliminary Data for 2007,” is available at www.cdc.gov/nchs

Less than half of some 1,100 surveyed primary care physicians in Texas said they follow current recommendations to vaccinate adolescent girls with the approved quadrivalent human papillomavirus vaccine.

The results suggest that “additional efforts are needed to improve clinician awareness of and adherence to national recommendations,” the study investigators reported in Cancer Epidemiology, Biomarkers & Prevention.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has recommended targeting HPV vaccination to 11- to 12-year-old girls. The group advises catch-up vaccinations in 13- to 26-year-old females and vaccination of 9- to 10-year-olds at the provider's discretion. The Food and Drug Administration has approved the vaccine for use in girls and women aged 9–26.

Of the 1,122 family physicians, pediatricians, ob.gyns., and internists who responded to the survey, 49% said they always recommend the HPV vaccine to girls aged 11–12. Sixty-four percent, however, said they always recommend vaccination for 13- to 17-year-old girls, “suggesting that parents or physicians may be delaying vaccination until girls are older than 12,” the authors said.

Nearly 70% of respondents said they would be “extremely” or “somewhat” likely to recommend the vaccine for boys aged 11–12, if the vaccine were approved for use in that population.

Physicians in academic settings were about twice as likely to recommend vaccination as their counterparts in nonacademic settings.

Barriers to recommending the vaccine included parental refusal because of concerns over vaccine safety (70%) and inadequate insurance coverage (67%), the researchers wrote (Cancer Epidemiol. Biomarkers Prev. 2009;18:25–32).

“Two years after the [FDA] approved the vaccine, the study suggests that additional efforts are needed to encourage physicians to follow these national recommendations,” Dr. Jessica A. Kahn, the study's lead author, said in a statement issued by the American Association for Cancer Research, which publishes the journal. “Most physicians are aware of the vaccine and what it prevents, but they may lack knowledge about issues of safety and how to address parental concerns. That may be making them reluctant to deliver the vaccine,” she added.

In the statement, Dr. Kahn, associate professor of pediatrics at Cincinnati Children's Hospital Medical Center, said she believed that the opinions of the Texas physicians “might also be representative of physicians in other states. The study notes that in 2007, HPV vaccination rates among girls aged 11–18 years in the United States ranged from about 6% to 25%, and that “physician endorsement of vaccination is one of the most important predictors of vaccine acceptance.”

Dr. Kahn is a co-principal investigator in a National Institutes of Health-sponsored study of use of the HPV vaccine in HIV-infected adolescents. Merck is providing the vaccine (Gardasil) used in that study.

Less than half of some 1,100 surveyed primary care physicians in Texas said they follow current recommendations to vaccinate adolescent girls with the approved quadrivalent human papillomavirus vaccine.

The results suggest that “additional efforts are needed to improve clinician awareness of and adherence to national recommendations,” the study investigators reported in Cancer Epidemiology, Biomarkers & Prevention.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has recommended targeting HPV vaccination to 11- to 12-year-old girls. The group advises catch-up vaccinations in 13- to 26-year-old females and vaccination of 9- to 10-year-olds at the provider's discretion. The Food and Drug Administration has approved the vaccine for use in girls and women aged 9–26.

Of the 1,122 family physicians, pediatricians, ob.gyns., and internists who responded to the survey, 49% said they always recommend the HPV vaccine to girls aged 11–12. Sixty-four percent, however, said they always recommend vaccination for 13- to 17-year-old girls, “suggesting that parents or physicians may be delaying vaccination until girls are older than 12,” the authors said.

Nearly 70% of respondents said they would be “extremely” or “somewhat” likely to recommend the vaccine for boys aged 11–12, if the vaccine were approved for use in that population.

Physicians in academic settings were about twice as likely to recommend vaccination as their counterparts in nonacademic settings.

Barriers to recommending the vaccine included parental refusal because of concerns over vaccine safety (70%) and inadequate insurance coverage (67%), the researchers wrote (Cancer Epidemiol. Biomarkers Prev. 2009;18:25–32).

“Two years after the [FDA] approved the vaccine, the study suggests that additional efforts are needed to encourage physicians to follow these national recommendations,” Dr. Jessica A. Kahn, the study's lead author, said in a statement issued by the American Association for Cancer Research, which publishes the journal. “Most physicians are aware of the vaccine and what it prevents, but they may lack knowledge about issues of safety and how to address parental concerns. That may be making them reluctant to deliver the vaccine,” she added.

In the statement, Dr. Kahn, associate professor of pediatrics at Cincinnati Children's Hospital Medical Center, said she believed that the opinions of the Texas physicians “might also be representative of physicians in other states. The study notes that in 2007, HPV vaccination rates among girls aged 11–18 years in the United States ranged from about 6% to 25%, and that “physician endorsement of vaccination is one of the most important predictors of vaccine acceptance.”

Dr. Kahn is a co-principal investigator in a National Institutes of Health-sponsored study of use of the HPV vaccine in HIV-infected adolescents. Merck is providing the vaccine (Gardasil) used in that study.

Less than half of some 1,100 surveyed primary care physicians in Texas said they follow current recommendations to vaccinate adolescent girls with the approved quadrivalent human papillomavirus vaccine.

The results suggest that “additional efforts are needed to improve clinician awareness of and adherence to national recommendations,” the study investigators reported in Cancer Epidemiology, Biomarkers & Prevention.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has recommended targeting HPV vaccination to 11- to 12-year-old girls. The group advises catch-up vaccinations in 13- to 26-year-old females and vaccination of 9- to 10-year-olds at the provider's discretion. The Food and Drug Administration has approved the vaccine for use in girls and women aged 9–26.

Of the 1,122 family physicians, pediatricians, ob.gyns., and internists who responded to the survey, 49% said they always recommend the HPV vaccine to girls aged 11–12. Sixty-four percent, however, said they always recommend vaccination for 13- to 17-year-old girls, “suggesting that parents or physicians may be delaying vaccination until girls are older than 12,” the authors said.

Nearly 70% of respondents said they would be “extremely” or “somewhat” likely to recommend the vaccine for boys aged 11–12, if the vaccine were approved for use in that population.

Physicians in academic settings were about twice as likely to recommend vaccination as their counterparts in nonacademic settings.

Barriers to recommending the vaccine included parental refusal because of concerns over vaccine safety (70%) and inadequate insurance coverage (67%), the researchers wrote (Cancer Epidemiol. Biomarkers Prev. 2009;18:25–32).

“Two years after the [FDA] approved the vaccine, the study suggests that additional efforts are needed to encourage physicians to follow these national recommendations,” Dr. Jessica A. Kahn, the study's lead author, said in a statement issued by the American Association for Cancer Research, which publishes the journal. “Most physicians are aware of the vaccine and what it prevents, but they may lack knowledge about issues of safety and how to address parental concerns. That may be making them reluctant to deliver the vaccine,” she added.

In the statement, Dr. Kahn, associate professor of pediatrics at Cincinnati Children's Hospital Medical Center, said she believed that the opinions of the Texas physicians “might also be representative of physicians in other states. The study notes that in 2007, HPV vaccination rates among girls aged 11–18 years in the United States ranged from about 6% to 25%, and that “physician endorsement of vaccination is one of the most important predictors of vaccine acceptance.”

Dr. Kahn is a co-principal investigator in a National Institutes of Health-sponsored study of use of the HPV vaccine in HIV-infected adolescents. Merck is providing the vaccine (Gardasil) used in that study.

The Food and Drug Administration has approved a new Haemophilus influenzae type b (Hib) vaccine for use as a booster dose in children aged 15 months through 4 years, providing another option for children whose boosters were deferred as a result of the nationwide Hib vaccine shortage that began almost 2 years ago.

The monovalent Hib vaccine is Hiberix (Haemophilus b conjugate vaccine [tetanus toxoid conjugate]), which is manufactured by GlaxoSmithKline (GSK). It was first marketed in Germany in 1996, and is now available in almost 100 countries, including the United States, according to the GSK Web site.

“This approval will provide an additional safe and effective vaccine to help ensure that there is an adequate Hib vaccine supply during necessary catch-up vaccinations,” Dr. Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research, said in a statement.

Under its accelerated approval program, the FDA concluded that Hiberix was safe and effective as a booster dose in the United States, based on data from seven studies of more than 1,000 children that was conducted in Europe, Latin America, and Canada. As a condition of the accelerated approval, GSK will conduct a postmarketing study of Hiberix in the United States, which will evaluate the safety and immunogenicity of Hiberix as a booster and primary vaccine, compared with a Hib vaccine that is already available in the United States, according to the statement.

The nationwide shortage of Hib vaccine dates back to December 2007, a result of a voluntary recall and subsequent suspension of Merck & Co.'s PedvaxHIB and COMVAX, two of the four Hib vaccines licensed in the United States for primary and booster doses. The shortage prompted the Centers for Disease Control and Prevention to recommend that the Hib booster be deferred for children who were not at high risk for infection, which was in effect from Dec. 18, 2007, through June 25, 2009. But after Sanofi-Aventis increased production of its Hib-containing vaccine doses in July 2009, the CDC recommended that the booster dose be reinstated with “limited catch-up” with the available monovalent and combination products.

Almost 3 weeks before the FDA's announcement, Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases, stressed the “critical importance” of reinstating the booster dose of Hib vaccine in children aged 12-15 months, in a July 30 letter to health care providers. She said that the CDC was aware of some providers who were delaying administering the catch-up booster dose until supplies of a monovalent vaccine became available, but advised against this practice.

She noted that although there was enough Hib vaccine available to return to providing the three doses of primary vaccinations and the booster dose, the supply of the combination vaccine Pentacel (DTaP-IPV/Hib) was increasing, and the supply of the monovalent vaccine was “near stable.” (At that time, Hiberix was not yet approved.) Therefore, “to reinstate the booster dose and maximize the number of children protected from Hib, most practices will need to incorporate DTaP-IPV/Hib, even if this is not their preference,” she said.

“We believe that we are in the final stretch of the Hib vaccine shortage,” Dr. Schuchat said in the July 30 letter. She said that CDC's Hib experts have not seen an increase in invasive Hib disease, but because of the potential for increased nasopharyngeal carriage of the Hib bacterium, “it is critical that providers continue to provide children with the full primary series and return to including the booster at this time.”

'It is critical that providers … return to including the [Hib] booster at this time.'

Source Dr. Schuchat

The Food and Drug Administration has approved a new Haemophilus influenzae type b (Hib) vaccine for use as a booster dose in children aged 15 months through 4 years, providing another option for children whose boosters were deferred as a result of the nationwide Hib vaccine shortage that began almost 2 years ago.

The monovalent Hib vaccine is Hiberix (Haemophilus b conjugate vaccine [tetanus toxoid conjugate]), which is manufactured by GlaxoSmithKline (GSK). It was first marketed in Germany in 1996, and is now available in almost 100 countries, including the United States, according to the GSK Web site.

“This approval will provide an additional safe and effective vaccine to help ensure that there is an adequate Hib vaccine supply during necessary catch-up vaccinations,” Dr. Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research, said in a statement.

Under its accelerated approval program, the FDA concluded that Hiberix was safe and effective as a booster dose in the United States, based on data from seven studies of more than 1,000 children that was conducted in Europe, Latin America, and Canada. As a condition of the accelerated approval, GSK will conduct a postmarketing study of Hiberix in the United States, which will evaluate the safety and immunogenicity of Hiberix as a booster and primary vaccine, compared with a Hib vaccine that is already available in the United States, according to the statement.

The nationwide shortage of Hib vaccine dates back to December 2007, a result of a voluntary recall and subsequent suspension of Merck & Co.'s PedvaxHIB and COMVAX, two of the four Hib vaccines licensed in the United States for primary and booster doses. The shortage prompted the Centers for Disease Control and Prevention to recommend that the Hib booster be deferred for children who were not at high risk for infection, which was in effect from Dec. 18, 2007, through June 25, 2009. But after Sanofi-Aventis increased production of its Hib-containing vaccine doses in July 2009, the CDC recommended that the booster dose be reinstated with “limited catch-up” with the available monovalent and combination products.

Almost 3 weeks before the FDA's announcement, Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases, stressed the “critical importance” of reinstating the booster dose of Hib vaccine in children aged 12-15 months, in a July 30 letter to health care providers. She said that the CDC was aware of some providers who were delaying administering the catch-up booster dose until supplies of a monovalent vaccine became available, but advised against this practice.

She noted that although there was enough Hib vaccine available to return to providing the three doses of primary vaccinations and the booster dose, the supply of the combination vaccine Pentacel (DTaP-IPV/Hib) was increasing, and the supply of the monovalent vaccine was “near stable.” (At that time, Hiberix was not yet approved.) Therefore, “to reinstate the booster dose and maximize the number of children protected from Hib, most practices will need to incorporate DTaP-IPV/Hib, even if this is not their preference,” she said.

“We believe that we are in the final stretch of the Hib vaccine shortage,” Dr. Schuchat said in the July 30 letter. She said that CDC's Hib experts have not seen an increase in invasive Hib disease, but because of the potential for increased nasopharyngeal carriage of the Hib bacterium, “it is critical that providers continue to provide children with the full primary series and return to including the booster at this time.”

'It is critical that providers … return to including the [Hib] booster at this time.'

Source Dr. Schuchat

The Food and Drug Administration has approved a new Haemophilus influenzae type b (Hib) vaccine for use as a booster dose in children aged 15 months through 4 years, providing another option for children whose boosters were deferred as a result of the nationwide Hib vaccine shortage that began almost 2 years ago.

The monovalent Hib vaccine is Hiberix (Haemophilus b conjugate vaccine [tetanus toxoid conjugate]), which is manufactured by GlaxoSmithKline (GSK). It was first marketed in Germany in 1996, and is now available in almost 100 countries, including the United States, according to the GSK Web site.

“This approval will provide an additional safe and effective vaccine to help ensure that there is an adequate Hib vaccine supply during necessary catch-up vaccinations,” Dr. Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research, said in a statement.

Under its accelerated approval program, the FDA concluded that Hiberix was safe and effective as a booster dose in the United States, based on data from seven studies of more than 1,000 children that was conducted in Europe, Latin America, and Canada. As a condition of the accelerated approval, GSK will conduct a postmarketing study of Hiberix in the United States, which will evaluate the safety and immunogenicity of Hiberix as a booster and primary vaccine, compared with a Hib vaccine that is already available in the United States, according to the statement.

The nationwide shortage of Hib vaccine dates back to December 2007, a result of a voluntary recall and subsequent suspension of Merck & Co.'s PedvaxHIB and COMVAX, two of the four Hib vaccines licensed in the United States for primary and booster doses. The shortage prompted the Centers for Disease Control and Prevention to recommend that the Hib booster be deferred for children who were not at high risk for infection, which was in effect from Dec. 18, 2007, through June 25, 2009. But after Sanofi-Aventis increased production of its Hib-containing vaccine doses in July 2009, the CDC recommended that the booster dose be reinstated with “limited catch-up” with the available monovalent and combination products.

Almost 3 weeks before the FDA's announcement, Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases, stressed the “critical importance” of reinstating the booster dose of Hib vaccine in children aged 12-15 months, in a July 30 letter to health care providers. She said that the CDC was aware of some providers who were delaying administering the catch-up booster dose until supplies of a monovalent vaccine became available, but advised against this practice.

She noted that although there was enough Hib vaccine available to return to providing the three doses of primary vaccinations and the booster dose, the supply of the combination vaccine Pentacel (DTaP-IPV/Hib) was increasing, and the supply of the monovalent vaccine was “near stable.” (At that time, Hiberix was not yet approved.) Therefore, “to reinstate the booster dose and maximize the number of children protected from Hib, most practices will need to incorporate DTaP-IPV/Hib, even if this is not their preference,” she said.

“We believe that we are in the final stretch of the Hib vaccine shortage,” Dr. Schuchat said in the July 30 letter. She said that CDC's Hib experts have not seen an increase in invasive Hib disease, but because of the potential for increased nasopharyngeal carriage of the Hib bacterium, “it is critical that providers continue to provide children with the full primary series and return to including the booster at this time.”

'It is critical that providers … return to including the [Hib] booster at this time.'

Source Dr. Schuchat

Less than half of some 1,100 surveyed primary care physicians in Texas said they follow current recommendations to vaccinate adolescent girls with the approved quadrivalent human papillomavirus vaccine.

The results suggest that "additional efforts are needed to improve clinician awareness of and adherence to national recommendations," the study investigators reported in Cancer Epidemiology, Biomarkers & Prevention.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has recommended targeting HPV vaccination to 11- to 12-year-old girls. The group advises catch-up vaccinations in 13- to 26-year-old females and vaccination of 9- to 10-year-olds at the provider's discretion. The Food and Drug Administration has approved the vaccine for use in girls and women aged 9–26.

Of the 1,122 physicians who responded to the survey, 49% said they always recommend the HPV vaccine to girls aged 11–12. Sixty-four percent, however, said they always recommend vaccination for 13- to 17-year-old girls, "suggesting that parents or physicians may be delaying vaccination until girls are older than 12," the authors said.

Nearly 70% of respondents said they would be "extremely" or "somewhat" likely to recommend the vaccine for boys aged 11–12, if the vaccine were approved for use in that population.

Physicians in academic settings were about twice as likely to recommend vaccination as their counterparts in nonacademic settings. Barriers to recommending the vaccine included parental refusal because of concerns over vaccine safety (70%) and inadequate insurance coverage (67%), the researchers wrote (Cancer Epidemiol. Biomarkers Prev. 2009;18:25–32).

"Two years after the [FDA] approved the vaccine, the study suggests that additional efforts are needed to encourage physicians to follow these national recommendations," Dr. Jessica A. Kahn, the study's lead author, said in a statement issued by the American Association for Cancer Research, which publishes the journal.

"Most physicians are aware of the vaccine and what it prevents, but they may lack knowledge about issues of safety and how to address parental concerns," she added.

In the statement, Dr. Kahn, associate professor of pediatrics at Cincinnati Children's Hospital Medical Center, said she believed that the opinions of the Texas physicians "might also be representative of physicians in other states. The study notes that in 2007, HPV vaccination rates among girls aged 11–18 years in the United States ranged from about 6% to 25%, and that "physician endorsement of vaccination is one of the most important predictors of vaccine acceptance."

Dr. Kahn is a co-principal investigator in a National Institutes of Health-sponsored study of use of the HPV vaccine in HIV-infected adolescents. Merck is providing the vaccine (Gardasil) used in that study.

Less than half of some 1,100 surveyed primary care physicians in Texas said they follow current recommendations to vaccinate adolescent girls with the approved quadrivalent human papillomavirus vaccine.

The results suggest that "additional efforts are needed to improve clinician awareness of and adherence to national recommendations," the study investigators reported in Cancer Epidemiology, Biomarkers & Prevention.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has recommended targeting HPV vaccination to 11- to 12-year-old girls. The group advises catch-up vaccinations in 13- to 26-year-old females and vaccination of 9- to 10-year-olds at the provider's discretion. The Food and Drug Administration has approved the vaccine for use in girls and women aged 9–26.

Of the 1,122 physicians who responded to the survey, 49% said they always recommend the HPV vaccine to girls aged 11–12. Sixty-four percent, however, said they always recommend vaccination for 13- to 17-year-old girls, "suggesting that parents or physicians may be delaying vaccination until girls are older than 12," the authors said.

Nearly 70% of respondents said they would be "extremely" or "somewhat" likely to recommend the vaccine for boys aged 11–12, if the vaccine were approved for use in that population.

Physicians in academic settings were about twice as likely to recommend vaccination as their counterparts in nonacademic settings. Barriers to recommending the vaccine included parental refusal because of concerns over vaccine safety (70%) and inadequate insurance coverage (67%), the researchers wrote (Cancer Epidemiol. Biomarkers Prev. 2009;18:25–32).

"Two years after the [FDA] approved the vaccine, the study suggests that additional efforts are needed to encourage physicians to follow these national recommendations," Dr. Jessica A. Kahn, the study's lead author, said in a statement issued by the American Association for Cancer Research, which publishes the journal.

"Most physicians are aware of the vaccine and what it prevents, but they may lack knowledge about issues of safety and how to address parental concerns," she added.

In the statement, Dr. Kahn, associate professor of pediatrics at Cincinnati Children's Hospital Medical Center, said she believed that the opinions of the Texas physicians "might also be representative of physicians in other states. The study notes that in 2007, HPV vaccination rates among girls aged 11–18 years in the United States ranged from about 6% to 25%, and that "physician endorsement of vaccination is one of the most important predictors of vaccine acceptance."

Dr. Kahn is a co-principal investigator in a National Institutes of Health-sponsored study of use of the HPV vaccine in HIV-infected adolescents. Merck is providing the vaccine (Gardasil) used in that study.

Less than half of some 1,100 surveyed primary care physicians in Texas said they follow current recommendations to vaccinate adolescent girls with the approved quadrivalent human papillomavirus vaccine.

The results suggest that "additional efforts are needed to improve clinician awareness of and adherence to national recommendations," the study investigators reported in Cancer Epidemiology, Biomarkers & Prevention.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has recommended targeting HPV vaccination to 11- to 12-year-old girls. The group advises catch-up vaccinations in 13- to 26-year-old females and vaccination of 9- to 10-year-olds at the provider's discretion. The Food and Drug Administration has approved the vaccine for use in girls and women aged 9–26.

Of the 1,122 physicians who responded to the survey, 49% said they always recommend the HPV vaccine to girls aged 11–12. Sixty-four percent, however, said they always recommend vaccination for 13- to 17-year-old girls, "suggesting that parents or physicians may be delaying vaccination until girls are older than 12," the authors said.

Nearly 70% of respondents said they would be "extremely" or "somewhat" likely to recommend the vaccine for boys aged 11–12, if the vaccine were approved for use in that population.

Physicians in academic settings were about twice as likely to recommend vaccination as their counterparts in nonacademic settings. Barriers to recommending the vaccine included parental refusal because of concerns over vaccine safety (70%) and inadequate insurance coverage (67%), the researchers wrote (Cancer Epidemiol. Biomarkers Prev. 2009;18:25–32).

"Two years after the [FDA] approved the vaccine, the study suggests that additional efforts are needed to encourage physicians to follow these national recommendations," Dr. Jessica A. Kahn, the study's lead author, said in a statement issued by the American Association for Cancer Research, which publishes the journal.

"Most physicians are aware of the vaccine and what it prevents, but they may lack knowledge about issues of safety and how to address parental concerns," she added.

In the statement, Dr. Kahn, associate professor of pediatrics at Cincinnati Children's Hospital Medical Center, said she believed that the opinions of the Texas physicians "might also be representative of physicians in other states. The study notes that in 2007, HPV vaccination rates among girls aged 11–18 years in the United States ranged from about 6% to 25%, and that "physician endorsement of vaccination is one of the most important predictors of vaccine acceptance."

Dr. Kahn is a co-principal investigator in a National Institutes of Health-sponsored study of use of the HPV vaccine in HIV-infected adolescents. Merck is providing the vaccine (Gardasil) used in that study.

The cancer risk warnings associated with tumor necrosis factor blockers will be strengthened to include the increased risk of cancer identified in children treated with drugs in this class, a result of an analysis of 48 reports of cancer in pediatric patients who were treated with these agents, according to a Food and Drug Administration statement.

The boxed warning in the prescribing information for these agents will “highlight the increased risk of cancer in children and adolescents who receive these drugs,” the statement said.

Information about reports of new-onset psoriasis during treatment with a TNF blocker will also be added to the prescribing information of these products, the FDA announced.

The adverse events section of the label will be updated to include information on reports of new-onset psoriasis associated with TNF-blocker therapy. Health care professionals should “be aware of the possibility and monitor for the emergence or worsening of psoriasis during treatment with TNF blockers, particularly pustular and palmoplantar forms of psoriasis,” according to the agency statement.

The FDA reviewed 69 cases of new-onset psoriasis (2 were pediatric cases), which appeared “weeks to years” after TNF treatment was started in people who had not reported having psoriasis previously. Almost half (32 cases) were pustular or palmoplantar forms. In 12 cases, patients were hospitalized.

In most cases, psoriasis improved once treatment was stopped. Because of the number of reports and the temporal relationship between the initiation of TNF blocker treatment and the onset of psoriasis, the “FDA concludes there is a possible association between the development of psoriasis and the use of these drugs,” the statement said.

The investigation of the malignancy reports, first announced in June 2008 by the FDA, concluded that TNF blocker treatment in children and adolescents was associated with an increased risk of cancer after an average of 30 months.

Lymphomas accounted for about half of the cancer cases, according to the FDA. Information about the higher-than-expected rate of lymphomas in adults who were treated with TNF-blockers is already included in the prescribing information.

Pediatric rheumatologist Thomas Lehman said that he expects this warning to deter some parents and physicians from the use of these agents. Several concerned parents and physicians had contacted him within a few days of the FDA statement to discuss the warning. Some children who could benefit from these medications will not receive them because of fears provoked by the warning, Dr. Lehman said in an interview.

But he said it was important to note that the FDA statement says that the agency could not “fully characterize the strength of the association” between TNF-blocker use and development of a malignancy.

In addition, “parents should be aware that they must balance a clearly very small risk of malignancy against the very large risk of damage from inadequately controlled arthritis,” said Dr. Lehman, chief of the division of pediatric rheumatology at the Hospital for Special Surgery in New York.

Physicians who were in practice before the anti-TNF drugs became available are familiar with the degree of pain and disability and the associated psychological toll that inadequately controlled arthritis takes on the child and family.

Dr. Lehman, who is also professor of clinical pediatrics at New York Weill Cornell Medical Center, is on the speakers bureau for Wyeth Pharmaceuticals and Amgen Inc., which market etanercept, and Abbott Laboratories, manufacturer of adalimumab.

The cancer risk warnings associated with tumor necrosis factor blockers will be strengthened to include the increased risk of cancer identified in children treated with drugs in this class, a result of an analysis of 48 reports of cancer in pediatric patients who were treated with these agents, according to a Food and Drug Administration statement.

The boxed warning in the prescribing information for these agents will “highlight the increased risk of cancer in children and adolescents who receive these drugs,” the statement said.

Information about reports of new-onset psoriasis during treatment with a TNF blocker will also be added to the prescribing information of these products, the FDA announced.

The adverse events section of the label will be updated to include information on reports of new-onset psoriasis associated with TNF-blocker therapy. Health care professionals should “be aware of the possibility and monitor for the emergence or worsening of psoriasis during treatment with TNF blockers, particularly pustular and palmoplantar forms of psoriasis,” according to the agency statement.

The FDA reviewed 69 cases of new-onset psoriasis (2 were pediatric cases), which appeared “weeks to years” after TNF treatment was started in people who had not reported having psoriasis previously. Almost half (32 cases) were pustular or palmoplantar forms. In 12 cases, patients were hospitalized.

In most cases, psoriasis improved once treatment was stopped. Because of the number of reports and the temporal relationship between the initiation of TNF blocker treatment and the onset of psoriasis, the “FDA concludes there is a possible association between the development of psoriasis and the use of these drugs,” the statement said.

The investigation of the malignancy reports, first announced in June 2008 by the FDA, concluded that TNF blocker treatment in children and adolescents was associated with an increased risk of cancer after an average of 30 months.

Lymphomas accounted for about half of the cancer cases, according to the FDA. Information about the higher-than-expected rate of lymphomas in adults who were treated with TNF-blockers is already included in the prescribing information.

Pediatric rheumatologist Thomas Lehman said that he expects this warning to deter some parents and physicians from the use of these agents. Several concerned parents and physicians had contacted him within a few days of the FDA statement to discuss the warning. Some children who could benefit from these medications will not receive them because of fears provoked by the warning, Dr. Lehman said in an interview.

But he said it was important to note that the FDA statement says that the agency could not “fully characterize the strength of the association” between TNF-blocker use and development of a malignancy.

In addition, “parents should be aware that they must balance a clearly very small risk of malignancy against the very large risk of damage from inadequately controlled arthritis,” said Dr. Lehman, chief of the division of pediatric rheumatology at the Hospital for Special Surgery in New York.

Physicians who were in practice before the anti-TNF drugs became available are familiar with the degree of pain and disability and the associated psychological toll that inadequately controlled arthritis takes on the child and family.

Dr. Lehman, who is also professor of clinical pediatrics at New York Weill Cornell Medical Center, is on the speakers bureau for Wyeth Pharmaceuticals and Amgen Inc., which market etanercept, and Abbott Laboratories, manufacturer of adalimumab.

The cancer risk warnings associated with tumor necrosis factor blockers will be strengthened to include the increased risk of cancer identified in children treated with drugs in this class, a result of an analysis of 48 reports of cancer in pediatric patients who were treated with these agents, according to a Food and Drug Administration statement.

The boxed warning in the prescribing information for these agents will “highlight the increased risk of cancer in children and adolescents who receive these drugs,” the statement said.

Information about reports of new-onset psoriasis during treatment with a TNF blocker will also be added to the prescribing information of these products, the FDA announced.

The adverse events section of the label will be updated to include information on reports of new-onset psoriasis associated with TNF-blocker therapy. Health care professionals should “be aware of the possibility and monitor for the emergence or worsening of psoriasis during treatment with TNF blockers, particularly pustular and palmoplantar forms of psoriasis,” according to the agency statement.

The FDA reviewed 69 cases of new-onset psoriasis (2 were pediatric cases), which appeared “weeks to years” after TNF treatment was started in people who had not reported having psoriasis previously. Almost half (32 cases) were pustular or palmoplantar forms. In 12 cases, patients were hospitalized.

In most cases, psoriasis improved once treatment was stopped. Because of the number of reports and the temporal relationship between the initiation of TNF blocker treatment and the onset of psoriasis, the “FDA concludes there is a possible association between the development of psoriasis and the use of these drugs,” the statement said.

The investigation of the malignancy reports, first announced in June 2008 by the FDA, concluded that TNF blocker treatment in children and adolescents was associated with an increased risk of cancer after an average of 30 months.

Lymphomas accounted for about half of the cancer cases, according to the FDA. Information about the higher-than-expected rate of lymphomas in adults who were treated with TNF-blockers is already included in the prescribing information.

Pediatric rheumatologist Thomas Lehman said that he expects this warning to deter some parents and physicians from the use of these agents. Several concerned parents and physicians had contacted him within a few days of the FDA statement to discuss the warning. Some children who could benefit from these medications will not receive them because of fears provoked by the warning, Dr. Lehman said in an interview.

But he said it was important to note that the FDA statement says that the agency could not “fully characterize the strength of the association” between TNF-blocker use and development of a malignancy.

In addition, “parents should be aware that they must balance a clearly very small risk of malignancy against the very large risk of damage from inadequately controlled arthritis,” said Dr. Lehman, chief of the division of pediatric rheumatology at the Hospital for Special Surgery in New York.

Physicians who were in practice before the anti-TNF drugs became available are familiar with the degree of pain and disability and the associated psychological toll that inadequately controlled arthritis takes on the child and family.

Dr. Lehman, who is also professor of clinical pediatrics at New York Weill Cornell Medical Center, is on the speakers bureau for Wyeth Pharmaceuticals and Amgen Inc., which market etanercept, and Abbott Laboratories, manufacturer of adalimumab.

A consumer information page, with alink to the approval letter, is posted at www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm176124.htm

Sculptra Aesthetic

(injectable poly-L-lactic acid, Sanofi-aventis)

Sculptra is an injectable filler containing microparticles of poly-L-lactic acid approved by the Food and Drug Administration in August for use in immune-competent people as a single regimen for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles “in which deep dermal grid pattern (cross-hatch) injection technique is appropriate,” according to the manufacturer. The injectable was first approved in 2004 for correcting lipoatrophy in HIV patients.

▸ Recommended Usage: Injected into the deep dermis. Injection requirements for Sculptra Aesthetic are “unique,” and include “a tunneling technique in a grid pattern that is medial to the nasolabial fold contour defect” being corrected, according to prescription information.

▸ Special Considerations: Contraindicated in patients with a hypersensitivity to any of the components of this product and those with a known history of keloid formation or hypertrophic scarring. The product has not been studied in the periorbital area, but use in this area has been associated with an increased risk of papules and nodules, according to reports in the literature. Side effects can include injection site discomfort, redness, bruising, bleeding, itching, and swelling, noted the manufacturer.

▸Comment: Poly-L-lactic acid is a biodegradable synthetic polymer that has been widely used for years in dissolvable stitches, bone screws, and facial implants, according to the FDA. A randomized, multicenter, evaluator-blinded controlled study of 233 immune-competent mostly female patients (mean age 51 years) with previously untreated nasolabial fold wrinkles and wrinkle assessment scores of 2 (shallow) through 4 (deep) was conducted.

Patients were treated with bilateral injections of Sculptra Aesthetic (at 3-week intervals for up to four treatments) or with CosmoPlast (INAMED Aesthetics) for a maximum of four sessions over 9 weeks. At 13 months, those who received Sculptra had improvements in wrinkle assessment scores in correction of the contour deficiency of the nasolabial folds. Improvements were maintained among those patients followed for up to 25 months, according to the prescribing information. CosmoPlast results were maintained for up to 3 months.

In an interview, Dr. Leslie S. Baumann, director of cosmetic dermatology at the University of Miami, said that she has used Sculptra off-label for hundreds of patients since it was approved in 2004. It is not her first choice for nasolabial folds, but she likes to use it for improving cheek volume, which is similar to the HIV lipoatrophy indication.

The biggest issue with Sculptra is that patients need to have four to eight treatments before they see any improvement in cheek volume, which is more expensive initially than other treatments, she said. Also, it is difficult to predict how many treatments people will need.

Dr. Baumann tells patients that they will need four to eight treatments 1 month apart, and that they usually will not see changes until the third or fourth treatment. It is worth it, though, “because once you get them the way you want them to look, it lasts 2–3 years,” she said.

The University of Miami was among the Sculptra Aesthetic study sites, and Dr. Baumann said she has been an investigator for Dermik Laboratories (the dermatology division of sanofi-aventis) and other major cosmetic filler manufacturers.

She described Sculptra as a “dermal stimulator” rather than a filler because it stimulates the dermis to make collagen. She cautioned that it should not be used in areas where there is a lot of movement, such as the corner of the mouth, because of the risk of developing hard lumps. “I've seen people with horrible lumps under their eyes and there's nothing you can do,” she said.

Dr. Baumann stressed the need to be properly trained in how to inject Sculptra. When she trains residents, “this is the last thing I'll teach them, because they really have to get their skills down.”

A consumer information page, with alink to the approval letter, is posted at www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm176124.htm

Sculptra Aesthetic

(injectable poly-L-lactic acid, Sanofi-aventis)

Sculptra is an injectable filler containing microparticles of poly-L-lactic acid approved by the Food and Drug Administration in August for use in immune-competent people as a single regimen for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles “in which deep dermal grid pattern (cross-hatch) injection technique is appropriate,” according to the manufacturer. The injectable was first approved in 2004 for correcting lipoatrophy in HIV patients.

▸ Recommended Usage: Injected into the deep dermis. Injection requirements for Sculptra Aesthetic are “unique,” and include “a tunneling technique in a grid pattern that is medial to the nasolabial fold contour defect” being corrected, according to prescription information.

▸ Special Considerations: Contraindicated in patients with a hypersensitivity to any of the components of this product and those with a known history of keloid formation or hypertrophic scarring. The product has not been studied in the periorbital area, but use in this area has been associated with an increased risk of papules and nodules, according to reports in the literature. Side effects can include injection site discomfort, redness, bruising, bleeding, itching, and swelling, noted the manufacturer.

▸Comment: Poly-L-lactic acid is a biodegradable synthetic polymer that has been widely used for years in dissolvable stitches, bone screws, and facial implants, according to the FDA. A randomized, multicenter, evaluator-blinded controlled study of 233 immune-competent mostly female patients (mean age 51 years) with previously untreated nasolabial fold wrinkles and wrinkle assessment scores of 2 (shallow) through 4 (deep) was conducted.

Patients were treated with bilateral injections of Sculptra Aesthetic (at 3-week intervals for up to four treatments) or with CosmoPlast (INAMED Aesthetics) for a maximum of four sessions over 9 weeks. At 13 months, those who received Sculptra had improvements in wrinkle assessment scores in correction of the contour deficiency of the nasolabial folds. Improvements were maintained among those patients followed for up to 25 months, according to the prescribing information. CosmoPlast results were maintained for up to 3 months.

In an interview, Dr. Leslie S. Baumann, director of cosmetic dermatology at the University of Miami, said that she has used Sculptra off-label for hundreds of patients since it was approved in 2004. It is not her first choice for nasolabial folds, but she likes to use it for improving cheek volume, which is similar to the HIV lipoatrophy indication.

The biggest issue with Sculptra is that patients need to have four to eight treatments before they see any improvement in cheek volume, which is more expensive initially than other treatments, she said. Also, it is difficult to predict how many treatments people will need.

Dr. Baumann tells patients that they will need four to eight treatments 1 month apart, and that they usually will not see changes until the third or fourth treatment. It is worth it, though, “because once you get them the way you want them to look, it lasts 2–3 years,” she said.

The University of Miami was among the Sculptra Aesthetic study sites, and Dr. Baumann said she has been an investigator for Dermik Laboratories (the dermatology division of sanofi-aventis) and other major cosmetic filler manufacturers.

She described Sculptra as a “dermal stimulator” rather than a filler because it stimulates the dermis to make collagen. She cautioned that it should not be used in areas where there is a lot of movement, such as the corner of the mouth, because of the risk of developing hard lumps. “I've seen people with horrible lumps under their eyes and there's nothing you can do,” she said.

Dr. Baumann stressed the need to be properly trained in how to inject Sculptra. When she trains residents, “this is the last thing I'll teach them, because they really have to get their skills down.”

A consumer information page, with alink to the approval letter, is posted at www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm176124.htm

Sculptra Aesthetic

(injectable poly-L-lactic acid, Sanofi-aventis)

Sculptra is an injectable filler containing microparticles of poly-L-lactic acid approved by the Food and Drug Administration in August for use in immune-competent people as a single regimen for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles “in which deep dermal grid pattern (cross-hatch) injection technique is appropriate,” according to the manufacturer. The injectable was first approved in 2004 for correcting lipoatrophy in HIV patients.

▸ Recommended Usage: Injected into the deep dermis. Injection requirements for Sculptra Aesthetic are “unique,” and include “a tunneling technique in a grid pattern that is medial to the nasolabial fold contour defect” being corrected, according to prescription information.

▸ Special Considerations: Contraindicated in patients with a hypersensitivity to any of the components of this product and those with a known history of keloid formation or hypertrophic scarring. The product has not been studied in the periorbital area, but use in this area has been associated with an increased risk of papules and nodules, according to reports in the literature. Side effects can include injection site discomfort, redness, bruising, bleeding, itching, and swelling, noted the manufacturer.

▸Comment: Poly-L-lactic acid is a biodegradable synthetic polymer that has been widely used for years in dissolvable stitches, bone screws, and facial implants, according to the FDA. A randomized, multicenter, evaluator-blinded controlled study of 233 immune-competent mostly female patients (mean age 51 years) with previously untreated nasolabial fold wrinkles and wrinkle assessment scores of 2 (shallow) through 4 (deep) was conducted.

Patients were treated with bilateral injections of Sculptra Aesthetic (at 3-week intervals for up to four treatments) or with CosmoPlast (INAMED Aesthetics) for a maximum of four sessions over 9 weeks. At 13 months, those who received Sculptra had improvements in wrinkle assessment scores in correction of the contour deficiency of the nasolabial folds. Improvements were maintained among those patients followed for up to 25 months, according to the prescribing information. CosmoPlast results were maintained for up to 3 months.

In an interview, Dr. Leslie S. Baumann, director of cosmetic dermatology at the University of Miami, said that she has used Sculptra off-label for hundreds of patients since it was approved in 2004. It is not her first choice for nasolabial folds, but she likes to use it for improving cheek volume, which is similar to the HIV lipoatrophy indication.

The biggest issue with Sculptra is that patients need to have four to eight treatments before they see any improvement in cheek volume, which is more expensive initially than other treatments, she said. Also, it is difficult to predict how many treatments people will need.

Dr. Baumann tells patients that they will need four to eight treatments 1 month apart, and that they usually will not see changes until the third or fourth treatment. It is worth it, though, “because once you get them the way you want them to look, it lasts 2–3 years,” she said.

The University of Miami was among the Sculptra Aesthetic study sites, and Dr. Baumann said she has been an investigator for Dermik Laboratories (the dermatology division of sanofi-aventis) and other major cosmetic filler manufacturers.

She described Sculptra as a “dermal stimulator” rather than a filler because it stimulates the dermis to make collagen. She cautioned that it should not be used in areas where there is a lot of movement, such as the corner of the mouth, because of the risk of developing hard lumps. “I've seen people with horrible lumps under their eyes and there's nothing you can do,” she said.

Dr. Baumann stressed the need to be properly trained in how to inject Sculptra. When she trains residents, “this is the last thing I'll teach them, because they really have to get their skills down.”

ADELPHI, MD. — Clinicians should educate their patients about the potential for hepatotoxicity with acetaminophen and make sure they understand acetaminophen is the active ingredient in Tylenol and is contained in many combination over-the-counter and prescription products, a Food and Drug Administration representative said at an advisory panel meeting on the topic.

During a briefing held after the meeting, Dr. Sandra Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research (CDER), said that there are multiple components to the problem and there is “probably not one [individual] thing that will reverse the trend of acetaminophen-related liver toxicity.”

The FDA convened the joint meeting of its Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and Anesthetic and Life Support Drugs Advisory Committee to seek input from a variety of specialists on different options proposed by the agency to address the ongoing problem of acetaminophen-induced liver injury.

At the meeting, the majority of the panel recommended major changes to acetaminophen-containing products, including lowering the maximum daily dose and single adult dose of acetaminophen in nonprescription products, limiting pediatric liquid formulations to only one concentration, and adding a boxed warning about the risk of liver damage to prescription acetaminophen combination products.

In other votes, the majority of the panel, in a 24-13 vote, did not support eliminating over-the-counter acetaminophen combination products.

But in a 20-17 vote, the panel narrowly voted to recommend the elimination of prescription products containing a combination of acetaminophen and other drugs such as oxycodone (Percocet) and hydrocodone. The hydrocodone-acetaminophen combination, which includes Vicodin, is the most commonly prescribed pain medication in the United States, and was identified as a common cause of acetaminophen-induced hepatotoxicity and the cause of many deaths related to liver failure.

Acetaminophen-induced hepatotoxicity is usually related to both unintentional and intentional ingestions of products containing acetaminophen that exceeds the maximum daily dose of 4 g/day, Dr. Gerald Dal Pan, director of CDER's Office of Surveillance and Epidemiology, said at the meeting.

Among the data from different speakers and sources presented at the meeting was a survey of emergency departments (EDs) that found that 50% (54,743) of acetaminophen-related visits to EDs in 2006-2007 were the result of “self-harm, of which almost half involved opioid-analgesic combinations, and 38% involved single-ingredient acetaminophen products. Almost 14,000 (10%) were for unsupervised ingestions among children under age 10, and about 13,000 (12%) were other types of unintentional overdoses.

Acetaminophen products account for about 640 cases of acute liver failure every year in the United States, according to the Centers of Disease Control and Prevention. In addition, 5% of calls to poison control centers in 2005 involved acetaminophen; 37% of those calls were in children under age 6 years, and 60% of the cases were unintentional.

In a 21-16 vote, the panel also recommended that the maximum daily dose of 4 g of acetaminophen recommended for nonprescription single-ingredient and combination products be reduced, and they voted 24-13 that the maximum nonprescription single adult dose be limited to 650 mg (two 325-mg tablets).

The panel voted 26-11 that the current acetaminophen OTC dosage—two doses of 500 mg—be switched to prescription status. Some panelists voting against this switch said it would create a barrier for some patients, particularly the elderly, to getting the medication, while some of those voting for the switch said it would provide an opportunity for direct discussion with patient about their pain.

The FDA usually follows its advisory panels' advice, which is not binding.

ADELPHI, MD. — Clinicians should educate their patients about the potential for hepatotoxicity with acetaminophen and make sure they understand acetaminophen is the active ingredient in Tylenol and is contained in many combination over-the-counter and prescription products, a Food and Drug Administration representative said at an advisory panel meeting on the topic.

During a briefing held after the meeting, Dr. Sandra Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research (CDER), said that there are multiple components to the problem and there is “probably not one [individual] thing that will reverse the trend of acetaminophen-related liver toxicity.”

The FDA convened the joint meeting of its Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and Anesthetic and Life Support Drugs Advisory Committee to seek input from a variety of specialists on different options proposed by the agency to address the ongoing problem of acetaminophen-induced liver injury.

At the meeting, the majority of the panel recommended major changes to acetaminophen-containing products, including lowering the maximum daily dose and single adult dose of acetaminophen in nonprescription products, limiting pediatric liquid formulations to only one concentration, and adding a boxed warning about the risk of liver damage to prescription acetaminophen combination products.

In other votes, the majority of the panel, in a 24-13 vote, did not support eliminating over-the-counter acetaminophen combination products.

But in a 20-17 vote, the panel narrowly voted to recommend the elimination of prescription products containing a combination of acetaminophen and other drugs such as oxycodone (Percocet) and hydrocodone. The hydrocodone-acetaminophen combination, which includes Vicodin, is the most commonly prescribed pain medication in the United States, and was identified as a common cause of acetaminophen-induced hepatotoxicity and the cause of many deaths related to liver failure.

Acetaminophen-induced hepatotoxicity is usually related to both unintentional and intentional ingestions of products containing acetaminophen that exceeds the maximum daily dose of 4 g/day, Dr. Gerald Dal Pan, director of CDER's Office of Surveillance and Epidemiology, said at the meeting.

Among the data from different speakers and sources presented at the meeting was a survey of emergency departments (EDs) that found that 50% (54,743) of acetaminophen-related visits to EDs in 2006-2007 were the result of “self-harm, of which almost half involved opioid-analgesic combinations, and 38% involved single-ingredient acetaminophen products. Almost 14,000 (10%) were for unsupervised ingestions among children under age 10, and about 13,000 (12%) were other types of unintentional overdoses.

Acetaminophen products account for about 640 cases of acute liver failure every year in the United States, according to the Centers of Disease Control and Prevention. In addition, 5% of calls to poison control centers in 2005 involved acetaminophen; 37% of those calls were in children under age 6 years, and 60% of the cases were unintentional.

In a 21-16 vote, the panel also recommended that the maximum daily dose of 4 g of acetaminophen recommended for nonprescription single-ingredient and combination products be reduced, and they voted 24-13 that the maximum nonprescription single adult dose be limited to 650 mg (two 325-mg tablets).

The panel voted 26-11 that the current acetaminophen OTC dosage—two doses of 500 mg—be switched to prescription status. Some panelists voting against this switch said it would create a barrier for some patients, particularly the elderly, to getting the medication, while some of those voting for the switch said it would provide an opportunity for direct discussion with patient about their pain.

The FDA usually follows its advisory panels' advice, which is not binding.

ADELPHI, MD. — Clinicians should educate their patients about the potential for hepatotoxicity with acetaminophen and make sure they understand acetaminophen is the active ingredient in Tylenol and is contained in many combination over-the-counter and prescription products, a Food and Drug Administration representative said at an advisory panel meeting on the topic.

During a briefing held after the meeting, Dr. Sandra Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research (CDER), said that there are multiple components to the problem and there is “probably not one [individual] thing that will reverse the trend of acetaminophen-related liver toxicity.”

The FDA convened the joint meeting of its Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and Anesthetic and Life Support Drugs Advisory Committee to seek input from a variety of specialists on different options proposed by the agency to address the ongoing problem of acetaminophen-induced liver injury.

At the meeting, the majority of the panel recommended major changes to acetaminophen-containing products, including lowering the maximum daily dose and single adult dose of acetaminophen in nonprescription products, limiting pediatric liquid formulations to only one concentration, and adding a boxed warning about the risk of liver damage to prescription acetaminophen combination products.

In other votes, the majority of the panel, in a 24-13 vote, did not support eliminating over-the-counter acetaminophen combination products.

But in a 20-17 vote, the panel narrowly voted to recommend the elimination of prescription products containing a combination of acetaminophen and other drugs such as oxycodone (Percocet) and hydrocodone. The hydrocodone-acetaminophen combination, which includes Vicodin, is the most commonly prescribed pain medication in the United States, and was identified as a common cause of acetaminophen-induced hepatotoxicity and the cause of many deaths related to liver failure.

Acetaminophen-induced hepatotoxicity is usually related to both unintentional and intentional ingestions of products containing acetaminophen that exceeds the maximum daily dose of 4 g/day, Dr. Gerald Dal Pan, director of CDER's Office of Surveillance and Epidemiology, said at the meeting.

Among the data from different speakers and sources presented at the meeting was a survey of emergency departments (EDs) that found that 50% (54,743) of acetaminophen-related visits to EDs in 2006-2007 were the result of “self-harm, of which almost half involved opioid-analgesic combinations, and 38% involved single-ingredient acetaminophen products. Almost 14,000 (10%) were for unsupervised ingestions among children under age 10, and about 13,000 (12%) were other types of unintentional overdoses.

Acetaminophen products account for about 640 cases of acute liver failure every year in the United States, according to the Centers of Disease Control and Prevention. In addition, 5% of calls to poison control centers in 2005 involved acetaminophen; 37% of those calls were in children under age 6 years, and 60% of the cases were unintentional.

In a 21-16 vote, the panel also recommended that the maximum daily dose of 4 g of acetaminophen recommended for nonprescription single-ingredient and combination products be reduced, and they voted 24-13 that the maximum nonprescription single adult dose be limited to 650 mg (two 325-mg tablets).

The panel voted 26-11 that the current acetaminophen OTC dosage—two doses of 500 mg—be switched to prescription status. Some panelists voting against this switch said it would create a barrier for some patients, particularly the elderly, to getting the medication, while some of those voting for the switch said it would provide an opportunity for direct discussion with patient about their pain.

The FDA usually follows its advisory panels' advice, which is not binding.

Last month, the Food and Drug Administration approved the antiplatelet agent prasugrel to reduce the risk of clotting during percutaneous coronary intervention, with labeling that includes a boxed warning about the potential for significant and sometimes fatal bleeding associated with the drug.

Specifically, prasugrel, a thienopyridine, was approved for reducing thrombotic cardiovascular events, including stent thrombosis, in the following patients with acute coronary syndrome who will be managed with percutaneous coronary intervention (PCI): those with unstable angina or non-ST elevation myocardial infarction (NSTEMI) and those with ST-elevation MI (STEMI), when managed with either primary or delayed PCI.

In the pivotal phase III TRITON-TIMI 38 trial of 13,608 patients with a threatened or actual myocardial infarction who were about to undergo angioplasty, prasugrel (Effient) was more effective than clopidogrel (Plavix) at reducing subsequent nonfatal myocardial infarction (9.1% vs. 7%). Patients with a history of stroke were more likely to have a repeat stroke on prasugrel, however. There was also a greater risk of significant bleeding events with prasugrel.

Because of that higher risk, prasugrel's labeling includes a boxed warning about the bleeding, which advises against using the drug in patients with active pathological bleeding, a history of transient ischemic attacks or stroke, or urgent need for surgery, including coronary artery bypass graft surgery.

“Effient offers physicians an alternative treatment for preventing dangerous blood clots from forming and causing a heart attack or stroke during or after an angioplasty procedure,” Dr. John Jenkins, director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research, said in a statement. “Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug.”

In February 2009, the FDA's Cardiovascular and Renal Drugs Advisory Committee voted unanimously that the drug's benefits outweighed its risk and backed prasugrel's approval. The drug was developed by Eli Lilly & Co. and Daiichi Sankyo Inc., and is available in 5-mg and 10-mg tablets. Treatment is started with a 60-mg single oral loading dose, followed by 10 mg once daily. The label says that 5 mg per day should be considered for patients who weigh less than 60 kg and advises that patients should also take 75–325 mg of aspirin a day.

Because of the large number of patients now receiving stents, “achieving a consistent and effective level of platelet inhibition is paramount to preventing stent thrombosis and myocardial ischemic events,” Dr. Curtiss Stinis, an interventional cardiologist at Scripps Clinic and Research Foundation, La Jolla, Calif., said in an interview. Noting that the effectiveness of clopidogrel can vary widely across individual patients, and that some patients do not have an adequate response to clopidogrel, despite increasing the dose, he said that for such patients, “prasugrel offers an alternative.” Dr. Stinis is director of peripheral interventions in the division of cardiovascular diseases at the Scripps Foundation.

In his own practice, Dr. Stinis said he expects that prasugrel will “definitely be useful” in patients who had had an inadequate response to clopidogrel by blood test assay, or who have already had an episode of stent thrombosis. He added, however, that it was likely that he would still routinely prescribe clopidogrel to patients who have an adequate response to that drug, and to elderly patients or patients with a previous stroke who are likely at a higher risk of bleeding with prasugrel.

Dr. Stinis said that he has been a speaker for Eli Lilly in the past.

Alicia Ault contributed to this report.

Last month, the Food and Drug Administration approved the antiplatelet agent prasugrel to reduce the risk of clotting during percutaneous coronary intervention, with labeling that includes a boxed warning about the potential for significant and sometimes fatal bleeding associated with the drug.

Specifically, prasugrel, a thienopyridine, was approved for reducing thrombotic cardiovascular events, including stent thrombosis, in the following patients with acute coronary syndrome who will be managed with percutaneous coronary intervention (PCI): those with unstable angina or non-ST elevation myocardial infarction (NSTEMI) and those with ST-elevation MI (STEMI), when managed with either primary or delayed PCI.

In the pivotal phase III TRITON-TIMI 38 trial of 13,608 patients with a threatened or actual myocardial infarction who were about to undergo angioplasty, prasugrel (Effient) was more effective than clopidogrel (Plavix) at reducing subsequent nonfatal myocardial infarction (9.1% vs. 7%). Patients with a history of stroke were more likely to have a repeat stroke on prasugrel, however. There was also a greater risk of significant bleeding events with prasugrel.

Because of that higher risk, prasugrel's labeling includes a boxed warning about the bleeding, which advises against using the drug in patients with active pathological bleeding, a history of transient ischemic attacks or stroke, or urgent need for surgery, including coronary artery bypass graft surgery.

“Effient offers physicians an alternative treatment for preventing dangerous blood clots from forming and causing a heart attack or stroke during or after an angioplasty procedure,” Dr. John Jenkins, director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research, said in a statement. “Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug.”

In February 2009, the FDA's Cardiovascular and Renal Drugs Advisory Committee voted unanimously that the drug's benefits outweighed its risk and backed prasugrel's approval. The drug was developed by Eli Lilly & Co. and Daiichi Sankyo Inc., and is available in 5-mg and 10-mg tablets. Treatment is started with a 60-mg single oral loading dose, followed by 10 mg once daily. The label says that 5 mg per day should be considered for patients who weigh less than 60 kg and advises that patients should also take 75–325 mg of aspirin a day.

Because of the large number of patients now receiving stents, “achieving a consistent and effective level of platelet inhibition is paramount to preventing stent thrombosis and myocardial ischemic events,” Dr. Curtiss Stinis, an interventional cardiologist at Scripps Clinic and Research Foundation, La Jolla, Calif., said in an interview. Noting that the effectiveness of clopidogrel can vary widely across individual patients, and that some patients do not have an adequate response to clopidogrel, despite increasing the dose, he said that for such patients, “prasugrel offers an alternative.” Dr. Stinis is director of peripheral interventions in the division of cardiovascular diseases at the Scripps Foundation.

In his own practice, Dr. Stinis said he expects that prasugrel will “definitely be useful” in patients who had had an inadequate response to clopidogrel by blood test assay, or who have already had an episode of stent thrombosis. He added, however, that it was likely that he would still routinely prescribe clopidogrel to patients who have an adequate response to that drug, and to elderly patients or patients with a previous stroke who are likely at a higher risk of bleeding with prasugrel.

Dr. Stinis said that he has been a speaker for Eli Lilly in the past.

Alicia Ault contributed to this report.

Last month, the Food and Drug Administration approved the antiplatelet agent prasugrel to reduce the risk of clotting during percutaneous coronary intervention, with labeling that includes a boxed warning about the potential for significant and sometimes fatal bleeding associated with the drug.

Specifically, prasugrel, a thienopyridine, was approved for reducing thrombotic cardiovascular events, including stent thrombosis, in the following patients with acute coronary syndrome who will be managed with percutaneous coronary intervention (PCI): those with unstable angina or non-ST elevation myocardial infarction (NSTEMI) and those with ST-elevation MI (STEMI), when managed with either primary or delayed PCI.

In the pivotal phase III TRITON-TIMI 38 trial of 13,608 patients with a threatened or actual myocardial infarction who were about to undergo angioplasty, prasugrel (Effient) was more effective than clopidogrel (Plavix) at reducing subsequent nonfatal myocardial infarction (9.1% vs. 7%). Patients with a history of stroke were more likely to have a repeat stroke on prasugrel, however. There was also a greater risk of significant bleeding events with prasugrel.

Because of that higher risk, prasugrel's labeling includes a boxed warning about the bleeding, which advises against using the drug in patients with active pathological bleeding, a history of transient ischemic attacks or stroke, or urgent need for surgery, including coronary artery bypass graft surgery.

“Effient offers physicians an alternative treatment for preventing dangerous blood clots from forming and causing a heart attack or stroke during or after an angioplasty procedure,” Dr. John Jenkins, director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research, said in a statement. “Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug.”

In February 2009, the FDA's Cardiovascular and Renal Drugs Advisory Committee voted unanimously that the drug's benefits outweighed its risk and backed prasugrel's approval. The drug was developed by Eli Lilly & Co. and Daiichi Sankyo Inc., and is available in 5-mg and 10-mg tablets. Treatment is started with a 60-mg single oral loading dose, followed by 10 mg once daily. The label says that 5 mg per day should be considered for patients who weigh less than 60 kg and advises that patients should also take 75–325 mg of aspirin a day.

Because of the large number of patients now receiving stents, “achieving a consistent and effective level of platelet inhibition is paramount to preventing stent thrombosis and myocardial ischemic events,” Dr. Curtiss Stinis, an interventional cardiologist at Scripps Clinic and Research Foundation, La Jolla, Calif., said in an interview. Noting that the effectiveness of clopidogrel can vary widely across individual patients, and that some patients do not have an adequate response to clopidogrel, despite increasing the dose, he said that for such patients, “prasugrel offers an alternative.” Dr. Stinis is director of peripheral interventions in the division of cardiovascular diseases at the Scripps Foundation.

In his own practice, Dr. Stinis said he expects that prasugrel will “definitely be useful” in patients who had had an inadequate response to clopidogrel by blood test assay, or who have already had an episode of stent thrombosis. He added, however, that it was likely that he would still routinely prescribe clopidogrel to patients who have an adequate response to that drug, and to elderly patients or patients with a previous stroke who are likely at a higher risk of bleeding with prasugrel.

Dr. Stinis said that he has been a speaker for Eli Lilly in the past.

Alicia Ault contributed to this report.

The long-awaited regulation on sunscreen labeling is expected to be issued by the Food and Drug Administration this fall, more than 2 years after the agency proposed the regulation to address issues concerning testing and labeling requirements for ultraviolet A protection.

Rita Chappelle, a spokesperson for the FDA, said in an interview that the agency anticipates a final ruling by September but is not providing any more specific information about what elements of the proposed rule would be included in the final rule.

The proposed rule, announced in the summer of 2007, includes a rating system that would use 1-4 stars on sunscreen product labels to indicate the degree of ultraviolet A (UVA) protection the product provides and a prominent warning regarding skin cancer and other risks of sun exposure in the “Drug Facts” box. The proposed rule also caps the maximum sun protection factor (SPF) claim allowed at SPF 50+ and includes guidance on how to measure UVA protection.

Ms. Chappelle also said that changes are being made to the proposed rule based on comments that the FDA received in response to the proposal—even those that came in after the 90-day comment period was closed in November 2007. The FDA received more than 3,000 comments in response to the proposal, which included a large amount of scientific data on topics such as UVA, UVB, and nanotechnology. The FDA had requested more information about the safety of sunscreen products that use nanotechnology because of the potential risk of nanoparticle ingredients penetrating the skin.

In an interview, Dr. Henry Lim, chairman of dermatology, at the Henry Ford Health System, Detroit, said that he did not know what the final rule would include, but that he and other dermatologists are looking forward to the release of the new regulations, which will be beneficial to consumers, particularly with the added information about UVA.

At a meeting that industry and American Academy of Dermatology representatives had with the FDA in December, Dr. Lim, chair of the Academy's council on science and research said that agency officials had questions about labeling issues, and asked industry representatives for information about the tests for UVA protection.

The long-awaited regulation on sunscreen labeling is expected to be issued by the Food and Drug Administration this fall, more than 2 years after the agency proposed the regulation to address issues concerning testing and labeling requirements for ultraviolet A protection.

Rita Chappelle, a spokesperson for the FDA, said in an interview that the agency anticipates a final ruling by September but is not providing any more specific information about what elements of the proposed rule would be included in the final rule.

The proposed rule, announced in the summer of 2007, includes a rating system that would use 1-4 stars on sunscreen product labels to indicate the degree of ultraviolet A (UVA) protection the product provides and a prominent warning regarding skin cancer and other risks of sun exposure in the “Drug Facts” box. The proposed rule also caps the maximum sun protection factor (SPF) claim allowed at SPF 50+ and includes guidance on how to measure UVA protection.

Ms. Chappelle also said that changes are being made to the proposed rule based on comments that the FDA received in response to the proposal—even those that came in after the 90-day comment period was closed in November 2007. The FDA received more than 3,000 comments in response to the proposal, which included a large amount of scientific data on topics such as UVA, UVB, and nanotechnology. The FDA had requested more information about the safety of sunscreen products that use nanotechnology because of the potential risk of nanoparticle ingredients penetrating the skin.

In an interview, Dr. Henry Lim, chairman of dermatology, at the Henry Ford Health System, Detroit, said that he did not know what the final rule would include, but that he and other dermatologists are looking forward to the release of the new regulations, which will be beneficial to consumers, particularly with the added information about UVA.

At a meeting that industry and American Academy of Dermatology representatives had with the FDA in December, Dr. Lim, chair of the Academy's council on science and research said that agency officials had questions about labeling issues, and asked industry representatives for information about the tests for UVA protection.

The long-awaited regulation on sunscreen labeling is expected to be issued by the Food and Drug Administration this fall, more than 2 years after the agency proposed the regulation to address issues concerning testing and labeling requirements for ultraviolet A protection.

Rita Chappelle, a spokesperson for the FDA, said in an interview that the agency anticipates a final ruling by September but is not providing any more specific information about what elements of the proposed rule would be included in the final rule.

The proposed rule, announced in the summer of 2007, includes a rating system that would use 1-4 stars on sunscreen product labels to indicate the degree of ultraviolet A (UVA) protection the product provides and a prominent warning regarding skin cancer and other risks of sun exposure in the “Drug Facts” box. The proposed rule also caps the maximum sun protection factor (SPF) claim allowed at SPF 50+ and includes guidance on how to measure UVA protection.

Ms. Chappelle also said that changes are being made to the proposed rule based on comments that the FDA received in response to the proposal—even those that came in after the 90-day comment period was closed in November 2007. The FDA received more than 3,000 comments in response to the proposal, which included a large amount of scientific data on topics such as UVA, UVB, and nanotechnology. The FDA had requested more information about the safety of sunscreen products that use nanotechnology because of the potential risk of nanoparticle ingredients penetrating the skin.

In an interview, Dr. Henry Lim, chairman of dermatology, at the Henry Ford Health System, Detroit, said that he did not know what the final rule would include, but that he and other dermatologists are looking forward to the release of the new regulations, which will be beneficial to consumers, particularly with the added information about UVA.

At a meeting that industry and American Academy of Dermatology representatives had with the FDA in December, Dr. Lim, chair of the Academy's council on science and research said that agency officials had questions about labeling issues, and asked industry representatives for information about the tests for UVA protection.