Elizabeth Mechcatie

The diphtheria, tetanus, and acellular pertussis (DTaP) vaccine manufactured by Sanofi-Pasteur was approved last month for use as the fifth consecutive dose of the vaccine series in children aged 4 through 6 years, following four previous doses of the same vaccine.

The vaccine, marketed as DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) by Sanofi-Pasteur, was approved for four consecutive doses in 2002, administered at 2, 4, 6, and 15–20 months of age. The Food and Drug Administration approved the fifth dose based on safety data and booster responses in a study of more than 400 children for the 4- to 6-year-old dose at 22 different sites, according to Sanofi-Pasteur.

From a practical standpoint, this approval allows physicians using DAPTACEL to stock one brand of the vaccine in the refrigerator for use for all five doses, Dr. Robert W. Frenck Jr., professor of pediatrics, Cincinnati Children's Hospital Medical Center, said in an interview.

There is no scientific reason to suspect that using different brand vaccines for a vaccine series in a child would be ineffective, but “from a purist standpoint, if you can use the same vaccine for the whole series, you may argue that it may have some benefit,” added Dr. Frenck, a member of the American Academy of Pediatrics' Committee on Infectious Diseases. He was not involved in DAPTACEL studies and had no conflicts to disclose.

The diphtheria, tetanus, and acellular pertussis (DTaP) vaccine manufactured by Sanofi-Pasteur was approved last month for use as the fifth consecutive dose of the vaccine series in children aged 4 through 6 years, following four previous doses of the same vaccine.

The vaccine, marketed as DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) by Sanofi-Pasteur, was approved for four consecutive doses in 2002, administered at 2, 4, 6, and 15–20 months of age. The Food and Drug Administration approved the fifth dose based on safety data and booster responses in a study of more than 400 children for the 4- to 6-year-old dose at 22 different sites, according to Sanofi-Pasteur.

From a practical standpoint, this approval allows physicians using DAPTACEL to stock one brand of the vaccine in the refrigerator for use for all five doses, Dr. Robert W. Frenck Jr., professor of pediatrics, Cincinnati Children's Hospital Medical Center, said in an interview.

There is no scientific reason to suspect that using different brand vaccines for a vaccine series in a child would be ineffective, but “from a purist standpoint, if you can use the same vaccine for the whole series, you may argue that it may have some benefit,” added Dr. Frenck, a member of the American Academy of Pediatrics' Committee on Infectious Diseases. He was not involved in DAPTACEL studies and had no conflicts to disclose.

The diphtheria, tetanus, and acellular pertussis (DTaP) vaccine manufactured by Sanofi-Pasteur was approved last month for use as the fifth consecutive dose of the vaccine series in children aged 4 through 6 years, following four previous doses of the same vaccine.

The vaccine, marketed as DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) by Sanofi-Pasteur, was approved for four consecutive doses in 2002, administered at 2, 4, 6, and 15–20 months of age. The Food and Drug Administration approved the fifth dose based on safety data and booster responses in a study of more than 400 children for the 4- to 6-year-old dose at 22 different sites, according to Sanofi-Pasteur.

From a practical standpoint, this approval allows physicians using DAPTACEL to stock one brand of the vaccine in the refrigerator for use for all five doses, Dr. Robert W. Frenck Jr., professor of pediatrics, Cincinnati Children's Hospital Medical Center, said in an interview.

There is no scientific reason to suspect that using different brand vaccines for a vaccine series in a child would be ineffective, but “from a purist standpoint, if you can use the same vaccine for the whole series, you may argue that it may have some benefit,” added Dr. Frenck, a member of the American Academy of Pediatrics' Committee on Infectious Diseases. He was not involved in DAPTACEL studies and had no conflicts to disclose.

The diphtheria, tetanus and acellular pertussis (DTaP) vaccine manufactured by Sanofi-Pasteur was approved last month for use as the fifth consecutive dose of the vaccine series in children aged 4 through 6 years, following four previous doses of the same vaccine.

The vaccine, marketed as DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) by Sanofi-Pasteur, was approved for four consecutive doses in 2002, administered at 2, 4, 6, and 15–20 months of age. The Food and Drug Administration approved the fifth dose last month, based on safety data and booster responses in a study of more than 400 children for the 4- to 6-year-old dose at 22 different sites, according to Sanofi-Pasteur.

From a practical standpoint, this approval allows pediatricians using DAPTACEL to stock one brand of the vaccine in the refrigerator for use for all five doses, Dr. Robert W. Frenck Jr., professor of pediatrics, Cincinnati Children's Hospital Medical Center, said in an interview.

Although there is no scientific reason to suspect that using different brand vaccines for a vaccine series in a child would be ineffective, “from a purist standpoint, if you can use the same vaccine for the whole series, you may argue that it may have some benefit,” added Dr. Frenck, a member of the American Academy of Pediatrics' Committee on Infectious Diseases.

He was not involved in DAPTACEL studies and had no conflicts to disclose.

The diphtheria, tetanus and acellular pertussis (DTaP) vaccine manufactured by Sanofi-Pasteur was approved last month for use as the fifth consecutive dose of the vaccine series in children aged 4 through 6 years, following four previous doses of the same vaccine.

The vaccine, marketed as DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) by Sanofi-Pasteur, was approved for four consecutive doses in 2002, administered at 2, 4, 6, and 15–20 months of age. The Food and Drug Administration approved the fifth dose last month, based on safety data and booster responses in a study of more than 400 children for the 4- to 6-year-old dose at 22 different sites, according to Sanofi-Pasteur.

From a practical standpoint, this approval allows pediatricians using DAPTACEL to stock one brand of the vaccine in the refrigerator for use for all five doses, Dr. Robert W. Frenck Jr., professor of pediatrics, Cincinnati Children's Hospital Medical Center, said in an interview.

Although there is no scientific reason to suspect that using different brand vaccines for a vaccine series in a child would be ineffective, “from a purist standpoint, if you can use the same vaccine for the whole series, you may argue that it may have some benefit,” added Dr. Frenck, a member of the American Academy of Pediatrics' Committee on Infectious Diseases.

He was not involved in DAPTACEL studies and had no conflicts to disclose.

The diphtheria, tetanus and acellular pertussis (DTaP) vaccine manufactured by Sanofi-Pasteur was approved last month for use as the fifth consecutive dose of the vaccine series in children aged 4 through 6 years, following four previous doses of the same vaccine.

The vaccine, marketed as DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) by Sanofi-Pasteur, was approved for four consecutive doses in 2002, administered at 2, 4, 6, and 15–20 months of age. The Food and Drug Administration approved the fifth dose last month, based on safety data and booster responses in a study of more than 400 children for the 4- to 6-year-old dose at 22 different sites, according to Sanofi-Pasteur.

From a practical standpoint, this approval allows pediatricians using DAPTACEL to stock one brand of the vaccine in the refrigerator for use for all five doses, Dr. Robert W. Frenck Jr., professor of pediatrics, Cincinnati Children's Hospital Medical Center, said in an interview.

Although there is no scientific reason to suspect that using different brand vaccines for a vaccine series in a child would be ineffective, “from a purist standpoint, if you can use the same vaccine for the whole series, you may argue that it may have some benefit,” added Dr. Frenck, a member of the American Academy of Pediatrics' Committee on Infectious Diseases.

He was not involved in DAPTACEL studies and had no conflicts to disclose.

The Food and Drug Administration approved the Rotarix vaccine on April 3, making it the second vaccine approved for the treatment of rotavirus in the United States.

The oral live-attenuated vaccine, manufactured by GlaxoSmithKline Biologicals, is approved for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children when administered as a two-dose series between the ages of 6 and 24 weeks, according to the FDA statement announcing the approval. Rotarix—previously approved in more than 100 countries, where more than 25 million doses have been distributed—will be available commercially in the United States in the second half of 2008, according to GSK.

Approval was based on the results of studies of more than 24,000 infants worldwide, which found that Rotarix was effective in preventing mild and severe cases of gastroenteritis caused by rotavirus during the first 2 years of life, the FDA said. Fussiness and irritability, cough and runny nose, fever, loss of appetite, and vomiting were the most common adverse events reported during the trials.

A study of more than 63,000 infants in Latin America and Finland, conducted by GSK to assess the risk of intussusception associated with Rotarix, found no increased risk among the 31,673 infants who received the vaccine, when compared with the 31,552 infants who received placebo.

An increased risk of intussusception led to the voluntary withdrawal of RotaShield—the first approved rotavirus vaccine—from the market in 1999. Rotateq, the live oral rotavirus vaccine manufactured by Merck & Co., was approved in February 2006; it is administered as a three-dose series to children between the ages of 6 and 32 weeks.

In the GSK intussusception study, however, the rates of pneumonia-related deaths and convulsions were higher among the vaccine recipients. The FDA has concluded that the available data “do not establish that these events are related to the vaccine,” but has requested that the company conduct a postmarketing study in the United States of more than 40,000 infants to provide more data on the vaccine's safety.

The observational study will enroll approximately 44,000 Rotarix recipients in the United States and will evaluate the potential increased risk of intussusception, Kawasaki disease, hospitalizations caused by acute lower respiratory tract infections, and convulsions.

That request reflects the recommendations of the FDA's Vaccines and Related Biological Products Advisory Committee, which reviewed the vaccine's safety and efficacy at a meeting in February. At that meeting, the panel voted 12–0 that the available data adequately supported the efficacy of Rotarix for preventing rotavirus caused by the serotypes included in the vaccine (G1, G2, G3, G4, and G9), and voted 11 to 1 that the data adequately supported the vaccine's safety. The panel, however, recommended a postmarketing study to follow adverse events associated with the previous rotavirus vaccines, including intussusception and Kawasaki disease, and the new signal for pneumonia deaths and a higher rate of convulsions in the Rotarix studies.

GSK's proposed indication for the vaccine included protection from the G2 subtype, but at the meeting, advisory panel members expressed concern about the vaccine's efficacy against the G2 serotype and agreed this issue could be addressed in the vaccine's labeling. The G2 strain is not included in the approved indication, which is for protection against the G1, G3, G4, and G9 strains of rotavirus.

At the FDA meeting, GSK also presented data that found that coadministration of Rotarix did not have a negative effect on the immune responses to the antigens in Pediarix, Prevnar, and ActHIB.

“This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children,” Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, said in the FDA statement.

Approximately 2.7 million cases of gastroenteritis in children in the United States every year are caused by rotavirus; about 55,000–70,000 of these children require hospitalization, and 20–60 deaths are caused by rotavirus, according to the FDA.

The Food and Drug Administration approved the Rotarix vaccine on April 3, making it the second vaccine approved for the treatment of rotavirus in the United States.

The oral live-attenuated vaccine, manufactured by GlaxoSmithKline Biologicals, is approved for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children when administered as a two-dose series between the ages of 6 and 24 weeks, according to the FDA statement announcing the approval. Rotarix—previously approved in more than 100 countries, where more than 25 million doses have been distributed—will be available commercially in the United States in the second half of 2008, according to GSK.

Approval was based on the results of studies of more than 24,000 infants worldwide, which found that Rotarix was effective in preventing mild and severe cases of gastroenteritis caused by rotavirus during the first 2 years of life, the FDA said. Fussiness and irritability, cough and runny nose, fever, loss of appetite, and vomiting were the most common adverse events reported during the trials.

A study of more than 63,000 infants in Latin America and Finland, conducted by GSK to assess the risk of intussusception associated with Rotarix, found no increased risk among the 31,673 infants who received the vaccine, when compared with the 31,552 infants who received placebo.

An increased risk of intussusception led to the voluntary withdrawal of RotaShield—the first approved rotavirus vaccine—from the market in 1999. Rotateq, the live oral rotavirus vaccine manufactured by Merck & Co., was approved in February 2006; it is administered as a three-dose series to children between the ages of 6 and 32 weeks.

In the GSK intussusception study, however, the rates of pneumonia-related deaths and convulsions were higher among the vaccine recipients. The FDA has concluded that the available data “do not establish that these events are related to the vaccine,” but has requested that the company conduct a postmarketing study in the United States of more than 40,000 infants to provide more data on the vaccine's safety.

The observational study will enroll approximately 44,000 Rotarix recipients in the United States and will evaluate the potential increased risk of intussusception, Kawasaki disease, hospitalizations caused by acute lower respiratory tract infections, and convulsions.

That request reflects the recommendations of the FDA's Vaccines and Related Biological Products Advisory Committee, which reviewed the vaccine's safety and efficacy at a meeting in February. At that meeting, the panel voted 12–0 that the available data adequately supported the efficacy of Rotarix for preventing rotavirus caused by the serotypes included in the vaccine (G1, G2, G3, G4, and G9), and voted 11 to 1 that the data adequately supported the vaccine's safety. The panel, however, recommended a postmarketing study to follow adverse events associated with the previous rotavirus vaccines, including intussusception and Kawasaki disease, and the new signal for pneumonia deaths and a higher rate of convulsions in the Rotarix studies.

GSK's proposed indication for the vaccine included protection from the G2 subtype, but at the meeting, advisory panel members expressed concern about the vaccine's efficacy against the G2 serotype and agreed this issue could be addressed in the vaccine's labeling. The G2 strain is not included in the approved indication, which is for protection against the G1, G3, G4, and G9 strains of rotavirus.

At the FDA meeting, GSK also presented data that found that coadministration of Rotarix did not have a negative effect on the immune responses to the antigens in Pediarix, Prevnar, and ActHIB.

“This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children,” Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, said in the FDA statement.

Approximately 2.7 million cases of gastroenteritis in children in the United States every year are caused by rotavirus; about 55,000–70,000 of these children require hospitalization, and 20–60 deaths are caused by rotavirus, according to the FDA.

The Food and Drug Administration approved the Rotarix vaccine on April 3, making it the second vaccine approved for the treatment of rotavirus in the United States.

The oral live-attenuated vaccine, manufactured by GlaxoSmithKline Biologicals, is approved for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children when administered as a two-dose series between the ages of 6 and 24 weeks, according to the FDA statement announcing the approval. Rotarix—previously approved in more than 100 countries, where more than 25 million doses have been distributed—will be available commercially in the United States in the second half of 2008, according to GSK.

Approval was based on the results of studies of more than 24,000 infants worldwide, which found that Rotarix was effective in preventing mild and severe cases of gastroenteritis caused by rotavirus during the first 2 years of life, the FDA said. Fussiness and irritability, cough and runny nose, fever, loss of appetite, and vomiting were the most common adverse events reported during the trials.

A study of more than 63,000 infants in Latin America and Finland, conducted by GSK to assess the risk of intussusception associated with Rotarix, found no increased risk among the 31,673 infants who received the vaccine, when compared with the 31,552 infants who received placebo.

An increased risk of intussusception led to the voluntary withdrawal of RotaShield—the first approved rotavirus vaccine—from the market in 1999. Rotateq, the live oral rotavirus vaccine manufactured by Merck & Co., was approved in February 2006; it is administered as a three-dose series to children between the ages of 6 and 32 weeks.

In the GSK intussusception study, however, the rates of pneumonia-related deaths and convulsions were higher among the vaccine recipients. The FDA has concluded that the available data “do not establish that these events are related to the vaccine,” but has requested that the company conduct a postmarketing study in the United States of more than 40,000 infants to provide more data on the vaccine's safety.

The observational study will enroll approximately 44,000 Rotarix recipients in the United States and will evaluate the potential increased risk of intussusception, Kawasaki disease, hospitalizations caused by acute lower respiratory tract infections, and convulsions.

That request reflects the recommendations of the FDA's Vaccines and Related Biological Products Advisory Committee, which reviewed the vaccine's safety and efficacy at a meeting in February. At that meeting, the panel voted 12–0 that the available data adequately supported the efficacy of Rotarix for preventing rotavirus caused by the serotypes included in the vaccine (G1, G2, G3, G4, and G9), and voted 11 to 1 that the data adequately supported the vaccine's safety. The panel, however, recommended a postmarketing study to follow adverse events associated with the previous rotavirus vaccines, including intussusception and Kawasaki disease, and the new signal for pneumonia deaths and a higher rate of convulsions in the Rotarix studies.

GSK's proposed indication for the vaccine included protection from the G2 subtype, but at the meeting, advisory panel members expressed concern about the vaccine's efficacy against the G2 serotype and agreed this issue could be addressed in the vaccine's labeling. The G2 strain is not included in the approved indication, which is for protection against the G1, G3, G4, and G9 strains of rotavirus.

At the FDA meeting, GSK also presented data that found that coadministration of Rotarix did not have a negative effect on the immune responses to the antigens in Pediarix, Prevnar, and ActHIB.

“This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children,” Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, said in the FDA statement.

Approximately 2.7 million cases of gastroenteritis in children in the United States every year are caused by rotavirus; about 55,000–70,000 of these children require hospitalization, and 20–60 deaths are caused by rotavirus, according to the FDA.

The Food and Drug Administration's recent approval of the tumor necrosis factor blocker adalimumab for treating juvenile idiopathic arthritis makes it the first biologic treatment approved for this indication since the 1999 approval of the TNF-blocker etanercept.

Adalimumab was approved for reducing the signs and symptoms of moderately to severely active juvenile idiopathic arthritis (JIA) in patients aged 4 years and older, alone or in combination with methotrexate. It is administered by a subcutaneous injection every other week, at doses based on weight.

Adalimumab is “an excellent choice for children with severe arthritis who need an anti-TNF agent,” Dr. Thomas Lehman, chief of the division of pediatric rheumatology, at the Hospital for Special Surgery, New York City, said in an interview. Although many children are initially controlled on etanercept, “those who break through often respond to Humira [adalimumab], as do most of those who do not respond to Enbrel [etanercept] initially,” he said.

Dr. Lehman said that adalimumab has been used extensively in pediatric patients over the past 4 years. “We've had excellent success in children with severe arthritis or uveitis associated with juvenile arthritis who have not responded to Enbrel,” he said. Dr. Lehman said he was not involved in the study that led to approval, but is a speaker for Abbott Laboratories, which markets adalimumab as Humira, and etanercept (Enbrel) manufacturer Amgen.

Approval was based on a four-phase, multicenter study of 171 children, aged 4–17 years with polyarticular JIA, with signs of active moderate or severe disease, despite previous treatment with NSAIDs, analgesics, corticosteroids, or disease-modifying antirheumatic drugs. (Patients who had been treated with biologic therapies before were excluded.) During the first phase, all patients received adalimumab for 16 weeks; 94% of those on methotrexate and 74% of those not on methotrexate had a pediatric American College of Rheumatology 30 response. These responders were randomized to continue to receive treatment or were switched to placebo; at the end of 32 weeks, significantly fewer of those who remained on adalimumab had disease flares, compared with those who were switched to placebo: Among those on methotrexate, 37% of those on adalimumab had a flare vs. 65% of those on placebo. Among those not on methotrexate, 43% of those on adalimumab had a flare vs. 71% of those on placebo.

ACR responses were maintained for up to 2 years among those who continued with treatment during the open-label extension phase of the study.

Overall, the type and frequency of adverse reactions were similar in the pediatric patients to those seen in adults. Neutropenia, streptococcal pharyngitis, increased aminotransferases, herpes zoster, myositis, metrorrhagia, and appendicitis were among the severe adverse reactions reported in the JIA study, according to Abbott. The labels for adalimumab and the other TNF blockers carry a black box warning about the risk of serious infections associated with treatment. In the JIA study, 4% of patients had a serious infection within about 2 years of starting treatment, and included herpes simplex, pneumonia, urinary tract infections, pharyngitis, and herpes zoster, according to Abbott.

The Food and Drug Administration's recent approval of the tumor necrosis factor blocker adalimumab for treating juvenile idiopathic arthritis makes it the first biologic treatment approved for this indication since the 1999 approval of the TNF-blocker etanercept.

Adalimumab was approved for reducing the signs and symptoms of moderately to severely active juvenile idiopathic arthritis (JIA) in patients aged 4 years and older, alone or in combination with methotrexate. It is administered by a subcutaneous injection every other week, at doses based on weight.

Adalimumab is “an excellent choice for children with severe arthritis who need an anti-TNF agent,” Dr. Thomas Lehman, chief of the division of pediatric rheumatology, at the Hospital for Special Surgery, New York City, said in an interview. Although many children are initially controlled on etanercept, “those who break through often respond to Humira [adalimumab], as do most of those who do not respond to Enbrel [etanercept] initially,” he said.

Dr. Lehman said that adalimumab has been used extensively in pediatric patients over the past 4 years. “We've had excellent success in children with severe arthritis or uveitis associated with juvenile arthritis who have not responded to Enbrel,” he said. Dr. Lehman said he was not involved in the study that led to approval, but is a speaker for Abbott Laboratories, which markets adalimumab as Humira, and etanercept (Enbrel) manufacturer Amgen.

Approval was based on a four-phase, multicenter study of 171 children, aged 4–17 years with polyarticular JIA, with signs of active moderate or severe disease, despite previous treatment with NSAIDs, analgesics, corticosteroids, or disease-modifying antirheumatic drugs. (Patients who had been treated with biologic therapies before were excluded.) During the first phase, all patients received adalimumab for 16 weeks; 94% of those on methotrexate and 74% of those not on methotrexate had a pediatric American College of Rheumatology 30 response. These responders were randomized to continue to receive treatment or were switched to placebo; at the end of 32 weeks, significantly fewer of those who remained on adalimumab had disease flares, compared with those who were switched to placebo: Among those on methotrexate, 37% of those on adalimumab had a flare vs. 65% of those on placebo. Among those not on methotrexate, 43% of those on adalimumab had a flare vs. 71% of those on placebo.

ACR responses were maintained for up to 2 years among those who continued with treatment during the open-label extension phase of the study.

Overall, the type and frequency of adverse reactions were similar in the pediatric patients to those seen in adults. Neutropenia, streptococcal pharyngitis, increased aminotransferases, herpes zoster, myositis, metrorrhagia, and appendicitis were among the severe adverse reactions reported in the JIA study, according to Abbott. The labels for adalimumab and the other TNF blockers carry a black box warning about the risk of serious infections associated with treatment. In the JIA study, 4% of patients had a serious infection within about 2 years of starting treatment, and included herpes simplex, pneumonia, urinary tract infections, pharyngitis, and herpes zoster, according to Abbott.

The Food and Drug Administration's recent approval of the tumor necrosis factor blocker adalimumab for treating juvenile idiopathic arthritis makes it the first biologic treatment approved for this indication since the 1999 approval of the TNF-blocker etanercept.

Adalimumab was approved for reducing the signs and symptoms of moderately to severely active juvenile idiopathic arthritis (JIA) in patients aged 4 years and older, alone or in combination with methotrexate. It is administered by a subcutaneous injection every other week, at doses based on weight.

Adalimumab is “an excellent choice for children with severe arthritis who need an anti-TNF agent,” Dr. Thomas Lehman, chief of the division of pediatric rheumatology, at the Hospital for Special Surgery, New York City, said in an interview. Although many children are initially controlled on etanercept, “those who break through often respond to Humira [adalimumab], as do most of those who do not respond to Enbrel [etanercept] initially,” he said.

Dr. Lehman said that adalimumab has been used extensively in pediatric patients over the past 4 years. “We've had excellent success in children with severe arthritis or uveitis associated with juvenile arthritis who have not responded to Enbrel,” he said. Dr. Lehman said he was not involved in the study that led to approval, but is a speaker for Abbott Laboratories, which markets adalimumab as Humira, and etanercept (Enbrel) manufacturer Amgen.

Approval was based on a four-phase, multicenter study of 171 children, aged 4–17 years with polyarticular JIA, with signs of active moderate or severe disease, despite previous treatment with NSAIDs, analgesics, corticosteroids, or disease-modifying antirheumatic drugs. (Patients who had been treated with biologic therapies before were excluded.) During the first phase, all patients received adalimumab for 16 weeks; 94% of those on methotrexate and 74% of those not on methotrexate had a pediatric American College of Rheumatology 30 response. These responders were randomized to continue to receive treatment or were switched to placebo; at the end of 32 weeks, significantly fewer of those who remained on adalimumab had disease flares, compared with those who were switched to placebo: Among those on methotrexate, 37% of those on adalimumab had a flare vs. 65% of those on placebo. Among those not on methotrexate, 43% of those on adalimumab had a flare vs. 71% of those on placebo.

ACR responses were maintained for up to 2 years among those who continued with treatment during the open-label extension phase of the study.

Overall, the type and frequency of adverse reactions were similar in the pediatric patients to those seen in adults. Neutropenia, streptococcal pharyngitis, increased aminotransferases, herpes zoster, myositis, metrorrhagia, and appendicitis were among the severe adverse reactions reported in the JIA study, according to Abbott. The labels for adalimumab and the other TNF blockers carry a black box warning about the risk of serious infections associated with treatment. In the JIA study, 4% of patients had a serious infection within about 2 years of starting treatment, and included herpes simplex, pneumonia, urinary tract infections, pharyngitis, and herpes zoster, according to Abbott.

The influenza-related hospitalization rates of young children with asthma were four times greater than those of children without asthma, and outpatient visits attributable to influenza were about twice as likely among those with asthma, according to Dr. E. Kathryn Miller and her associates.

The results are similar to those of retrospective studies that found that the rate of influenza-attributable outpatient visits for children with asthma and other medical conditions was higher than among healthy children, the investigators noted. But they added that their study may be the first to use prospective, laboratory-confirmed surveillance over several years to estimate rates of influenza-attributable visits for these two groups of children in outpatient settings (Pediatrics 2008;121:1-8).

The investigators conducted a prospective study that included children aged 6-59 months. Patients were either hospitalized between 2000 and 2004 or presented to clinics or emergency departments with acute respiratory illnesses (ARIs) or fever during two flu seasons between 2002 and 2004. In both the hospital and outpatient settings, throat and nasal swabs were obtained and tested for influenza, said Dr. Miller of the department of pediatrics at Vanderbilt University in Nashville, Tenn.

Of the 1,468 children hospitalized, 81 (6%) had lab-confirmed influenza; about one-quarter of these 81 children had asthma. Among children aged 6-23 months, the average annual rate of hospitalizations attributable to influenza was 2.8 cases/1,000 children with asthma, compared with 0.6 cases/1,000 children among healthy children, a significant difference. But the difference was not significant among those children aged 24-59 months: 0.6 cases/1,000 children among those with asthma, vs. 0.2 cases/1,000 children among the healthy children.

Among the 1,432 children enrolled in the outpatient settings, influenza was confirmed in 249 patients (17%); 15% had asthma. Among the children aged 6-23 months with asthma, the average annual rate of outpatient visits attributable to influenza was 316/1,000 children, compared with 152/1,000 children among healthy children. Among those children aged 24-59 months, the rates were 188 cases/1,000 children with asthma, vs. 102 cases/1,000 healthy children in 2003-2004. Both differences were statistically significant.

The authors speculated that possible explanations for the higher rates of inpatient and outpatient visits among children with asthma included their greater susceptibility to influenza and the greater likelihood they will have a more severe influenza-related illness.

They also may be more likely to seek medical help for a fever or ARI and may be more likely to be hospitalized because of concerns about their risk of asthma exacerbations, the investigators noted.

Vaccination rates were low in both groups: About 27% of those children with asthma had been vaccinated, and 12%–15% of the children without asthma had been vaccinated, according to parent reports.

The influenza-related hospitalization rates of young children with asthma were four times greater than those of children without asthma, and outpatient visits attributable to influenza were about twice as likely among those with asthma, according to Dr. E. Kathryn Miller and her associates.

The results are similar to those of retrospective studies that found that the rate of influenza-attributable outpatient visits for children with asthma and other medical conditions was higher than among healthy children, the investigators noted. But they added that their study may be the first to use prospective, laboratory-confirmed surveillance over several years to estimate rates of influenza-attributable visits for these two groups of children in outpatient settings (Pediatrics 2008;121:1-8).

The investigators conducted a prospective study that included children aged 6-59 months. Patients were either hospitalized between 2000 and 2004 or presented to clinics or emergency departments with acute respiratory illnesses (ARIs) or fever during two flu seasons between 2002 and 2004. In both the hospital and outpatient settings, throat and nasal swabs were obtained and tested for influenza, said Dr. Miller of the department of pediatrics at Vanderbilt University in Nashville, Tenn.

Of the 1,468 children hospitalized, 81 (6%) had lab-confirmed influenza; about one-quarter of these 81 children had asthma. Among children aged 6-23 months, the average annual rate of hospitalizations attributable to influenza was 2.8 cases/1,000 children with asthma, compared with 0.6 cases/1,000 children among healthy children, a significant difference. But the difference was not significant among those children aged 24-59 months: 0.6 cases/1,000 children among those with asthma, vs. 0.2 cases/1,000 children among the healthy children.

Among the 1,432 children enrolled in the outpatient settings, influenza was confirmed in 249 patients (17%); 15% had asthma. Among the children aged 6-23 months with asthma, the average annual rate of outpatient visits attributable to influenza was 316/1,000 children, compared with 152/1,000 children among healthy children. Among those children aged 24-59 months, the rates were 188 cases/1,000 children with asthma, vs. 102 cases/1,000 healthy children in 2003-2004. Both differences were statistically significant.

The authors speculated that possible explanations for the higher rates of inpatient and outpatient visits among children with asthma included their greater susceptibility to influenza and the greater likelihood they will have a more severe influenza-related illness.

They also may be more likely to seek medical help for a fever or ARI and may be more likely to be hospitalized because of concerns about their risk of asthma exacerbations, the investigators noted.

Vaccination rates were low in both groups: About 27% of those children with asthma had been vaccinated, and 12%–15% of the children without asthma had been vaccinated, according to parent reports.

The influenza-related hospitalization rates of young children with asthma were four times greater than those of children without asthma, and outpatient visits attributable to influenza were about twice as likely among those with asthma, according to Dr. E. Kathryn Miller and her associates.

The results are similar to those of retrospective studies that found that the rate of influenza-attributable outpatient visits for children with asthma and other medical conditions was higher than among healthy children, the investigators noted. But they added that their study may be the first to use prospective, laboratory-confirmed surveillance over several years to estimate rates of influenza-attributable visits for these two groups of children in outpatient settings (Pediatrics 2008;121:1-8).

The investigators conducted a prospective study that included children aged 6-59 months. Patients were either hospitalized between 2000 and 2004 or presented to clinics or emergency departments with acute respiratory illnesses (ARIs) or fever during two flu seasons between 2002 and 2004. In both the hospital and outpatient settings, throat and nasal swabs were obtained and tested for influenza, said Dr. Miller of the department of pediatrics at Vanderbilt University in Nashville, Tenn.

Of the 1,468 children hospitalized, 81 (6%) had lab-confirmed influenza; about one-quarter of these 81 children had asthma. Among children aged 6-23 months, the average annual rate of hospitalizations attributable to influenza was 2.8 cases/1,000 children with asthma, compared with 0.6 cases/1,000 children among healthy children, a significant difference. But the difference was not significant among those children aged 24-59 months: 0.6 cases/1,000 children among those with asthma, vs. 0.2 cases/1,000 children among the healthy children.

Among the 1,432 children enrolled in the outpatient settings, influenza was confirmed in 249 patients (17%); 15% had asthma. Among the children aged 6-23 months with asthma, the average annual rate of outpatient visits attributable to influenza was 316/1,000 children, compared with 152/1,000 children among healthy children. Among those children aged 24-59 months, the rates were 188 cases/1,000 children with asthma, vs. 102 cases/1,000 healthy children in 2003-2004. Both differences were statistically significant.

The authors speculated that possible explanations for the higher rates of inpatient and outpatient visits among children with asthma included their greater susceptibility to influenza and the greater likelihood they will have a more severe influenza-related illness.

They also may be more likely to seek medical help for a fever or ARI and may be more likely to be hospitalized because of concerns about their risk of asthma exacerbations, the investigators noted.

Vaccination rates were low in both groups: About 27% of those children with asthma had been vaccinated, and 12%–15% of the children without asthma had been vaccinated, according to parent reports.

Every year an estimated 7,091 children under age 12 are treated in U.S. emergency departments for adverse events related to over-the-counter and prescription cough and cold medications.

Almost two-thirds of these visits were due to unsupervised ingestions, reported Dr. Melissa K. Schaefer and her associates at the Centers for Disease Control and Prevention. The estimate is based on emergency department (ED) visits for adverse drug events attributable to cough and cold medications, identified from a nationally representative sample of 63 emergency departments in 2004 and 2005. The 7,091 visits make up almost 6% of all ED visits related to all medications in this age group; 66% of the study visits were related to unsupervised ingestions–significantly higher than the 47% of ED visits related to unsupervised ingestions of other medications. The cough and cold products contained decongestants, expectorants, or combinations of decongestants, antihistamines, antitussive, and/or expectorant ingredients.

Hospital admission or extended observation was not needed in 93% of these cases, but 23% of patients had to undergo gastric decontamination. In over half of the cases, no symptoms were noted in the ED. However, among children who were symptomatic, 19% had allergic symptoms and 13% had neurologic symptoms.

The investigators noted that surveillance data from this and future studies could “help target education, enforcement, and engineering strategies for reducing adverse events from cough and cold medications among children.”

The study, which will be published in the April print issue of Pediatrics, appeared on the journal's Web site (http://pediatrics.aappublications.org/cgi/content/abstract/peds.2007-3638v3

Every year an estimated 7,091 children under age 12 are treated in U.S. emergency departments for adverse events related to over-the-counter and prescription cough and cold medications.

Almost two-thirds of these visits were due to unsupervised ingestions, reported Dr. Melissa K. Schaefer and her associates at the Centers for Disease Control and Prevention. The estimate is based on emergency department (ED) visits for adverse drug events attributable to cough and cold medications, identified from a nationally representative sample of 63 emergency departments in 2004 and 2005. The 7,091 visits make up almost 6% of all ED visits related to all medications in this age group; 66% of the study visits were related to unsupervised ingestions–significantly higher than the 47% of ED visits related to unsupervised ingestions of other medications. The cough and cold products contained decongestants, expectorants, or combinations of decongestants, antihistamines, antitussive, and/or expectorant ingredients.

Hospital admission or extended observation was not needed in 93% of these cases, but 23% of patients had to undergo gastric decontamination. In over half of the cases, no symptoms were noted in the ED. However, among children who were symptomatic, 19% had allergic symptoms and 13% had neurologic symptoms.

The investigators noted that surveillance data from this and future studies could “help target education, enforcement, and engineering strategies for reducing adverse events from cough and cold medications among children.”

The study, which will be published in the April print issue of Pediatrics, appeared on the journal's Web site (http://pediatrics.aappublications.org/cgi/content/abstract/peds.2007-3638v3

Every year an estimated 7,091 children under age 12 are treated in U.S. emergency departments for adverse events related to over-the-counter and prescription cough and cold medications.

Almost two-thirds of these visits were due to unsupervised ingestions, reported Dr. Melissa K. Schaefer and her associates at the Centers for Disease Control and Prevention. The estimate is based on emergency department (ED) visits for adverse drug events attributable to cough and cold medications, identified from a nationally representative sample of 63 emergency departments in 2004 and 2005. The 7,091 visits make up almost 6% of all ED visits related to all medications in this age group; 66% of the study visits were related to unsupervised ingestions–significantly higher than the 47% of ED visits related to unsupervised ingestions of other medications. The cough and cold products contained decongestants, expectorants, or combinations of decongestants, antihistamines, antitussive, and/or expectorant ingredients.

Hospital admission or extended observation was not needed in 93% of these cases, but 23% of patients had to undergo gastric decontamination. In over half of the cases, no symptoms were noted in the ED. However, among children who were symptomatic, 19% had allergic symptoms and 13% had neurologic symptoms.

The investigators noted that surveillance data from this and future studies could “help target education, enforcement, and engineering strategies for reducing adverse events from cough and cold medications among children.”

The study, which will be published in the April print issue of Pediatrics, appeared on the journal's Web site (http://pediatrics.aappublications.org/cgi/content/abstract/peds.2007-3638v3

The public health advisory is available at www.fda.gov/cder/drug/advisory/cough_cold_2008.htmwww.fda.gov/consumer/updates/coughcold011708.html

The Food and Drug Administration has released a public health advisory strongly recommending against the use of over-the-counter cough and cold products in children and infants aged under 2 years, but will not issue recommendations until the spring about the use of these products in children aged 2-11 years.

During a telebriefing, Dr. Charles Ganley, director of the FDA's Office of Nonprescription Products, said that the agency had completed its safety review of these products in children aged under 2 years and concluded that the products should not be used in this age group because of the risk of “serious and potentially life-threatening side effects.” The advisory is based on a review of information the agency received about serious side effects–including deaths and seizures–associated with the use of these products in children this young. Also contributing to the decision were discussions and recommendations made at the FDA's Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee joint meeting in October 2007, where the advisory panel members agreed that there was no available scientific evidence that these products were safe and effective in children aged under 12 years, and they voted 21-1 that these products should not be used in children under age 2.

Still pending, however, is the final decision about the use of over-the-counter (OTC) cough and cold products in children aged 2-11 years. An internal working group is continuing to deliberate over what to recommend for this age group.

At the October meeting, the panels voted 13-9 that these products should not be used in children aged 2-5 years, but they voted 15-7 in favor of keeping them available for children aged 6-11 years. Dr. Ganley said that there was debate over differences of opinion among the working group, which has been reviewing this issue since the panel meeting in October. The agency plans to make final recommendations in the spring, he said.

But the group unanimously agreed that that the data in children under 2 years raised significant concerns and that OTC cough and cold products should not be used in this age group. Part of the reason the FDA decided to release the advisory now is that it is the middle of cough and cold season and there is evidence that parents and caregivers of children may be continuing to administer these products to children under age 2 without consulting their health care providers, according to Dr. Ganley.

He referred to a survey of parents of children younger than 2 years of age–conducted by National Public Radio, the Kaiser Family Foundation, and the Harvard School of Public Health in November 2007. When asked what best described their reaction to the recent news about the safety and effectiveness of the OTC cough and cold products for children, 20% said they planned to continue using these products, 26% were undecided, and 15% had not heard about the discussions. (Sixteen percent said they planned to stop using these products, 22% said they had never used or planned to use them, and 1% were in the “other” category.)

And at a workshop on OTC product use among adolescents, held by the FDA and Consumer Healthcare Products Association (CHPA) last fall, a survey of parents aged 16-25 years with infants younger than 12 months of age found that 86% considered the use of OTC cough and cold medications appropriate for children under age 2 years, without consulting a physician. “That's the problem we're trying to address today,” Dr. Ganley said.

The agency has never endorsed the use of these products in children this young, and in the past, has left it up to the discretion of the health care provider to decide whether their use was appropriate. Shortly before the October panel meeting, manufacturers of products with wording and images of infants on the packaging of these products voluntarily pulled them off the market, and the CHPA and its member companies recommended to the FDA that the “ask a doctor” statement on the labels of these products be changed to “do not use” in children under age 2–a suggestion which is supported by the agency, he said.

The public health advisory is available at www.fda.gov/cder/drug/advisory/cough_cold_2008.htmwww.fda.gov/consumer/updates/coughcold011708.html

The Food and Drug Administration has released a public health advisory strongly recommending against the use of over-the-counter cough and cold products in children and infants aged under 2 years, but will not issue recommendations until the spring about the use of these products in children aged 2-11 years.

During a telebriefing, Dr. Charles Ganley, director of the FDA's Office of Nonprescription Products, said that the agency had completed its safety review of these products in children aged under 2 years and concluded that the products should not be used in this age group because of the risk of “serious and potentially life-threatening side effects.” The advisory is based on a review of information the agency received about serious side effects–including deaths and seizures–associated with the use of these products in children this young. Also contributing to the decision were discussions and recommendations made at the FDA's Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee joint meeting in October 2007, where the advisory panel members agreed that there was no available scientific evidence that these products were safe and effective in children aged under 12 years, and they voted 21-1 that these products should not be used in children under age 2.

Still pending, however, is the final decision about the use of over-the-counter (OTC) cough and cold products in children aged 2-11 years. An internal working group is continuing to deliberate over what to recommend for this age group.

At the October meeting, the panels voted 13-9 that these products should not be used in children aged 2-5 years, but they voted 15-7 in favor of keeping them available for children aged 6-11 years. Dr. Ganley said that there was debate over differences of opinion among the working group, which has been reviewing this issue since the panel meeting in October. The agency plans to make final recommendations in the spring, he said.

But the group unanimously agreed that that the data in children under 2 years raised significant concerns and that OTC cough and cold products should not be used in this age group. Part of the reason the FDA decided to release the advisory now is that it is the middle of cough and cold season and there is evidence that parents and caregivers of children may be continuing to administer these products to children under age 2 without consulting their health care providers, according to Dr. Ganley.

He referred to a survey of parents of children younger than 2 years of age–conducted by National Public Radio, the Kaiser Family Foundation, and the Harvard School of Public Health in November 2007. When asked what best described their reaction to the recent news about the safety and effectiveness of the OTC cough and cold products for children, 20% said they planned to continue using these products, 26% were undecided, and 15% had not heard about the discussions. (Sixteen percent said they planned to stop using these products, 22% said they had never used or planned to use them, and 1% were in the “other” category.)

And at a workshop on OTC product use among adolescents, held by the FDA and Consumer Healthcare Products Association (CHPA) last fall, a survey of parents aged 16-25 years with infants younger than 12 months of age found that 86% considered the use of OTC cough and cold medications appropriate for children under age 2 years, without consulting a physician. “That's the problem we're trying to address today,” Dr. Ganley said.

The agency has never endorsed the use of these products in children this young, and in the past, has left it up to the discretion of the health care provider to decide whether their use was appropriate. Shortly before the October panel meeting, manufacturers of products with wording and images of infants on the packaging of these products voluntarily pulled them off the market, and the CHPA and its member companies recommended to the FDA that the “ask a doctor” statement on the labels of these products be changed to “do not use” in children under age 2–a suggestion which is supported by the agency, he said.

The public health advisory is available at www.fda.gov/cder/drug/advisory/cough_cold_2008.htmwww.fda.gov/consumer/updates/coughcold011708.html

The Food and Drug Administration has released a public health advisory strongly recommending against the use of over-the-counter cough and cold products in children and infants aged under 2 years, but will not issue recommendations until the spring about the use of these products in children aged 2-11 years.

During a telebriefing, Dr. Charles Ganley, director of the FDA's Office of Nonprescription Products, said that the agency had completed its safety review of these products in children aged under 2 years and concluded that the products should not be used in this age group because of the risk of “serious and potentially life-threatening side effects.” The advisory is based on a review of information the agency received about serious side effects–including deaths and seizures–associated with the use of these products in children this young. Also contributing to the decision were discussions and recommendations made at the FDA's Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee joint meeting in October 2007, where the advisory panel members agreed that there was no available scientific evidence that these products were safe and effective in children aged under 12 years, and they voted 21-1 that these products should not be used in children under age 2.

Still pending, however, is the final decision about the use of over-the-counter (OTC) cough and cold products in children aged 2-11 years. An internal working group is continuing to deliberate over what to recommend for this age group.

At the October meeting, the panels voted 13-9 that these products should not be used in children aged 2-5 years, but they voted 15-7 in favor of keeping them available for children aged 6-11 years. Dr. Ganley said that there was debate over differences of opinion among the working group, which has been reviewing this issue since the panel meeting in October. The agency plans to make final recommendations in the spring, he said.

But the group unanimously agreed that that the data in children under 2 years raised significant concerns and that OTC cough and cold products should not be used in this age group. Part of the reason the FDA decided to release the advisory now is that it is the middle of cough and cold season and there is evidence that parents and caregivers of children may be continuing to administer these products to children under age 2 without consulting their health care providers, according to Dr. Ganley.

He referred to a survey of parents of children younger than 2 years of age–conducted by National Public Radio, the Kaiser Family Foundation, and the Harvard School of Public Health in November 2007. When asked what best described their reaction to the recent news about the safety and effectiveness of the OTC cough and cold products for children, 20% said they planned to continue using these products, 26% were undecided, and 15% had not heard about the discussions. (Sixteen percent said they planned to stop using these products, 22% said they had never used or planned to use them, and 1% were in the “other” category.)

And at a workshop on OTC product use among adolescents, held by the FDA and Consumer Healthcare Products Association (CHPA) last fall, a survey of parents aged 16-25 years with infants younger than 12 months of age found that 86% considered the use of OTC cough and cold medications appropriate for children under age 2 years, without consulting a physician. “That's the problem we're trying to address today,” Dr. Ganley said.

The agency has never endorsed the use of these products in children this young, and in the past, has left it up to the discretion of the health care provider to decide whether their use was appropriate. Shortly before the October panel meeting, manufacturers of products with wording and images of infants on the packaging of these products voluntarily pulled them off the market, and the CHPA and its member companies recommended to the FDA that the “ask a doctor” statement on the labels of these products be changed to “do not use” in children under age 2–a suggestion which is supported by the agency, he said.

A study of preschool-age, inner-city children with asthma found marked fluctuations in the degree of asthma control within 3 months, suggesting that frequent evaluations of asthma control in this population may be warranted, investigators reported.

“We know asthma is an unstable disease, but we underestimated just how unpredictably it could behave over time, especially in inner-city kids,” the study's lead author, Dr. Hemant P. Sharma, noted in a statement issued by Johns Hopkins University, Baltimore, where he is a pediatric allergist.

The 6-month study of 150 predominantly black children aged 2–6 years (mean age 4.4 years) with asthma living in Baltimore evaluated their long-term controller medication use and their use of asthma-related health care at baseline, and at 3 and 6 months. At baseline, the children were classified into National Asthma Education and Prevention Program control categories for asthma: mild intermittent (37%), mild persistent (17%), moderate persistent (21%), and severe persistent (25%).

Only 39% of the children reported long-term use of controller medication (inhaled corticosteroids, cromolyn and nedocromil, oral leukotriene modifiers, long-acting β-agonists, and oral theophylline), wrote Dr. Sharma and his associates.

At 3 months, asthma control had deteriorated in 46% of the children who had mild intermittent asthma at baseline and in 33% of those with mild persistent asthma at baseline. Changes in control also were seen at 3 months in more than half of the children with moderate persistent asthma at baseline and in about half of those with severe persistent asthma at baseline.

Among children with persistent symptoms at baseline, “even greater shifts were observed between baseline and 6 months,” at which time a change in the degree of asthma control was seen in more than two-thirds of the children with persistent symptoms at baseline (Pediatrics 2007;120[5]:e1174–81).

These results “underscore the labile nature of asthma,” and suggest that assessments of asthma control in young, inner-city children “should be repeated at least every 3 months to take advantage of opportunities to prevent future morbidity,” Dr. Sharma and his associates said.

Poor control of asthma was an independent predictor of the children's use of asthma-related health care (unscheduled doctor visits, emergency department visits, and hospitalizations) during the preceding 3 months, with a significant association between poor asthma control and recent use of asthma-related health care, “suggesting that asthma control is related to overall recent disease activity,” they said. For example, 5% of those with mild intermittent asthma had an unscheduled doctor visit related to asthma within the previous 3 months, compared with 23% of those with moderate persistent asthma, and 42% of those with severe persistent asthma.

Their reported use of long-term controller medications, however, was not an independent predictor of their use of asthma-related health care.

The ability to accurately identify children who are at the greatest risk of morbidity in the future is a “key component” of successfully preventing asthma-related health care use and targeting high-risk children, but information about which clinical factors predict the risk of future asthma-related health care use among children is lacking, the authors wrote.

These findings have “direct implications to inner-city black children, who bear much of the asthma burden in the United States.” The authors indicated they have no financial relationships to disclose.

A study of preschool-age, inner-city children with asthma found marked fluctuations in the degree of asthma control within 3 months, suggesting that frequent evaluations of asthma control in this population may be warranted, investigators reported.

“We know asthma is an unstable disease, but we underestimated just how unpredictably it could behave over time, especially in inner-city kids,” the study's lead author, Dr. Hemant P. Sharma, noted in a statement issued by Johns Hopkins University, Baltimore, where he is a pediatric allergist.

The 6-month study of 150 predominantly black children aged 2–6 years (mean age 4.4 years) with asthma living in Baltimore evaluated their long-term controller medication use and their use of asthma-related health care at baseline, and at 3 and 6 months. At baseline, the children were classified into National Asthma Education and Prevention Program control categories for asthma: mild intermittent (37%), mild persistent (17%), moderate persistent (21%), and severe persistent (25%).

Only 39% of the children reported long-term use of controller medication (inhaled corticosteroids, cromolyn and nedocromil, oral leukotriene modifiers, long-acting β-agonists, and oral theophylline), wrote Dr. Sharma and his associates.

At 3 months, asthma control had deteriorated in 46% of the children who had mild intermittent asthma at baseline and in 33% of those with mild persistent asthma at baseline. Changes in control also were seen at 3 months in more than half of the children with moderate persistent asthma at baseline and in about half of those with severe persistent asthma at baseline.

Among children with persistent symptoms at baseline, “even greater shifts were observed between baseline and 6 months,” at which time a change in the degree of asthma control was seen in more than two-thirds of the children with persistent symptoms at baseline (Pediatrics 2007;120[5]:e1174–81).

These results “underscore the labile nature of asthma,” and suggest that assessments of asthma control in young, inner-city children “should be repeated at least every 3 months to take advantage of opportunities to prevent future morbidity,” Dr. Sharma and his associates said.

Poor control of asthma was an independent predictor of the children's use of asthma-related health care (unscheduled doctor visits, emergency department visits, and hospitalizations) during the preceding 3 months, with a significant association between poor asthma control and recent use of asthma-related health care, “suggesting that asthma control is related to overall recent disease activity,” they said. For example, 5% of those with mild intermittent asthma had an unscheduled doctor visit related to asthma within the previous 3 months, compared with 23% of those with moderate persistent asthma, and 42% of those with severe persistent asthma.

Their reported use of long-term controller medications, however, was not an independent predictor of their use of asthma-related health care.

The ability to accurately identify children who are at the greatest risk of morbidity in the future is a “key component” of successfully preventing asthma-related health care use and targeting high-risk children, but information about which clinical factors predict the risk of future asthma-related health care use among children is lacking, the authors wrote.

These findings have “direct implications to inner-city black children, who bear much of the asthma burden in the United States.” The authors indicated they have no financial relationships to disclose.

A study of preschool-age, inner-city children with asthma found marked fluctuations in the degree of asthma control within 3 months, suggesting that frequent evaluations of asthma control in this population may be warranted, investigators reported.

“We know asthma is an unstable disease, but we underestimated just how unpredictably it could behave over time, especially in inner-city kids,” the study's lead author, Dr. Hemant P. Sharma, noted in a statement issued by Johns Hopkins University, Baltimore, where he is a pediatric allergist.

The 6-month study of 150 predominantly black children aged 2–6 years (mean age 4.4 years) with asthma living in Baltimore evaluated their long-term controller medication use and their use of asthma-related health care at baseline, and at 3 and 6 months. At baseline, the children were classified into National Asthma Education and Prevention Program control categories for asthma: mild intermittent (37%), mild persistent (17%), moderate persistent (21%), and severe persistent (25%).

Only 39% of the children reported long-term use of controller medication (inhaled corticosteroids, cromolyn and nedocromil, oral leukotriene modifiers, long-acting β-agonists, and oral theophylline), wrote Dr. Sharma and his associates.

At 3 months, asthma control had deteriorated in 46% of the children who had mild intermittent asthma at baseline and in 33% of those with mild persistent asthma at baseline. Changes in control also were seen at 3 months in more than half of the children with moderate persistent asthma at baseline and in about half of those with severe persistent asthma at baseline.

Among children with persistent symptoms at baseline, “even greater shifts were observed between baseline and 6 months,” at which time a change in the degree of asthma control was seen in more than two-thirds of the children with persistent symptoms at baseline (Pediatrics 2007;120[5]:e1174–81).

These results “underscore the labile nature of asthma,” and suggest that assessments of asthma control in young, inner-city children “should be repeated at least every 3 months to take advantage of opportunities to prevent future morbidity,” Dr. Sharma and his associates said.

Poor control of asthma was an independent predictor of the children's use of asthma-related health care (unscheduled doctor visits, emergency department visits, and hospitalizations) during the preceding 3 months, with a significant association between poor asthma control and recent use of asthma-related health care, “suggesting that asthma control is related to overall recent disease activity,” they said. For example, 5% of those with mild intermittent asthma had an unscheduled doctor visit related to asthma within the previous 3 months, compared with 23% of those with moderate persistent asthma, and 42% of those with severe persistent asthma.

Their reported use of long-term controller medications, however, was not an independent predictor of their use of asthma-related health care.

The ability to accurately identify children who are at the greatest risk of morbidity in the future is a “key component” of successfully preventing asthma-related health care use and targeting high-risk children, but information about which clinical factors predict the risk of future asthma-related health care use among children is lacking, the authors wrote.

These findings have “direct implications to inner-city black children, who bear much of the asthma burden in the United States.” The authors indicated they have no financial relationships to disclose.

The influenza-related hospitalization rates of young children with asthma were four times greater than those of children without asthma, and outpatient visits attributable to influenza were about twice as likely among those with asthma, according to Dr. E. Kathryn Miller and her associates.

The results are similar to those of retrospective studies that found that the rate of influenza-attributable outpatient visits for children with asthma and other medical conditions was higher than among healthy children, the investigators noted. But they added that their study may be the first to use prospective, laboratory-confirmed surveillance over several years to estimate rates of influenza-attributable visits for these two groups of children in outpatient settings (Pediatrics 2008;121:1–8).

The investigators conducted a prospective study that included children aged 6–59 months. Patients were either hospitalized between 2000 and 2004 or presented to clinics or emergency departments with acute respiratory illnesses (ARIs) or fever during two flu seasons between 2002 and 2004. In both the hospital and outpatient settings, throat and nasal swabs were obtained and tested for influenza, said Dr. Miller of the department of pediatrics at Vanderbilt University in Nashville, Tenn.

Of the 1,468 children hospitalized, 81 (6%) had lab-confirmed influenza; about one-quarter of these 81 children had asthma. Among children aged 6–23 months, the average annual rate of hospitalizations attributable to influenza was 2.8 cases/1,000 children with asthma, compared with 0.6 cases/1,000 children among healthy children, a significant difference. But the difference was not significant among those children aged 24–59 months: 0.6 cases/1,000 children among those with asthma, compared with 0.2 cases/1,000 children among the healthy children.

Among the 1,432 children enrolled in the outpatient settings, influenza was confirmed in 249 patients (17%); 15% had asthma. Among the children aged 6–23 months with asthma, the average annual rate of outpatient visits attributable to influenza was 316/1,000 children, compared with 152/1,000 children among healthy children. Among those children aged 24–59 months, the rates were 188 cases/1,000 children with asthma, compared with 102 cases/1,000 healthy children in 2003–2004. Both differences were statistically significant.

The authors speculated that possible explanations for the higher rates of inpatient and outpatient visits among children with asthma included their greater susceptibility to influenza and the greater likelihood they will have a more severe influenza-related illness. They also may be more likely to seek medical help for a fever or ARI and may be more likely to be hospitalized because of concerns about their risk of asthma exacerbations, the investigators noted.

Vaccination rates were low in both groups: About 27% of those children with asthma had been vaccinated, and 12%–15% of the children without asthma had been vaccinated, according to parent reports. “Targeted strategies to increase the influenza vaccination rates for both children with asthma and healthy children [aged] 6–59 months are needed,” the researchers said.

The influenza-related hospitalization rates of young children with asthma were four times greater than those of children without asthma, and outpatient visits attributable to influenza were about twice as likely among those with asthma, according to Dr. E. Kathryn Miller and her associates.

The results are similar to those of retrospective studies that found that the rate of influenza-attributable outpatient visits for children with asthma and other medical conditions was higher than among healthy children, the investigators noted. But they added that their study may be the first to use prospective, laboratory-confirmed surveillance over several years to estimate rates of influenza-attributable visits for these two groups of children in outpatient settings (Pediatrics 2008;121:1–8).

The investigators conducted a prospective study that included children aged 6–59 months. Patients were either hospitalized between 2000 and 2004 or presented to clinics or emergency departments with acute respiratory illnesses (ARIs) or fever during two flu seasons between 2002 and 2004. In both the hospital and outpatient settings, throat and nasal swabs were obtained and tested for influenza, said Dr. Miller of the department of pediatrics at Vanderbilt University in Nashville, Tenn.

Of the 1,468 children hospitalized, 81 (6%) had lab-confirmed influenza; about one-quarter of these 81 children had asthma. Among children aged 6–23 months, the average annual rate of hospitalizations attributable to influenza was 2.8 cases/1,000 children with asthma, compared with 0.6 cases/1,000 children among healthy children, a significant difference. But the difference was not significant among those children aged 24–59 months: 0.6 cases/1,000 children among those with asthma, compared with 0.2 cases/1,000 children among the healthy children.

Among the 1,432 children enrolled in the outpatient settings, influenza was confirmed in 249 patients (17%); 15% had asthma. Among the children aged 6–23 months with asthma, the average annual rate of outpatient visits attributable to influenza was 316/1,000 children, compared with 152/1,000 children among healthy children. Among those children aged 24–59 months, the rates were 188 cases/1,000 children with asthma, compared with 102 cases/1,000 healthy children in 2003–2004. Both differences were statistically significant.

The authors speculated that possible explanations for the higher rates of inpatient and outpatient visits among children with asthma included their greater susceptibility to influenza and the greater likelihood they will have a more severe influenza-related illness. They also may be more likely to seek medical help for a fever or ARI and may be more likely to be hospitalized because of concerns about their risk of asthma exacerbations, the investigators noted.

Vaccination rates were low in both groups: About 27% of those children with asthma had been vaccinated, and 12%–15% of the children without asthma had been vaccinated, according to parent reports. “Targeted strategies to increase the influenza vaccination rates for both children with asthma and healthy children [aged] 6–59 months are needed,” the researchers said.

The influenza-related hospitalization rates of young children with asthma were four times greater than those of children without asthma, and outpatient visits attributable to influenza were about twice as likely among those with asthma, according to Dr. E. Kathryn Miller and her associates.

The results are similar to those of retrospective studies that found that the rate of influenza-attributable outpatient visits for children with asthma and other medical conditions was higher than among healthy children, the investigators noted. But they added that their study may be the first to use prospective, laboratory-confirmed surveillance over several years to estimate rates of influenza-attributable visits for these two groups of children in outpatient settings (Pediatrics 2008;121:1–8).

The investigators conducted a prospective study that included children aged 6–59 months. Patients were either hospitalized between 2000 and 2004 or presented to clinics or emergency departments with acute respiratory illnesses (ARIs) or fever during two flu seasons between 2002 and 2004. In both the hospital and outpatient settings, throat and nasal swabs were obtained and tested for influenza, said Dr. Miller of the department of pediatrics at Vanderbilt University in Nashville, Tenn.

Of the 1,468 children hospitalized, 81 (6%) had lab-confirmed influenza; about one-quarter of these 81 children had asthma. Among children aged 6–23 months, the average annual rate of hospitalizations attributable to influenza was 2.8 cases/1,000 children with asthma, compared with 0.6 cases/1,000 children among healthy children, a significant difference. But the difference was not significant among those children aged 24–59 months: 0.6 cases/1,000 children among those with asthma, compared with 0.2 cases/1,000 children among the healthy children.

Among the 1,432 children enrolled in the outpatient settings, influenza was confirmed in 249 patients (17%); 15% had asthma. Among the children aged 6–23 months with asthma, the average annual rate of outpatient visits attributable to influenza was 316/1,000 children, compared with 152/1,000 children among healthy children. Among those children aged 24–59 months, the rates were 188 cases/1,000 children with asthma, compared with 102 cases/1,000 healthy children in 2003–2004. Both differences were statistically significant.

The authors speculated that possible explanations for the higher rates of inpatient and outpatient visits among children with asthma included their greater susceptibility to influenza and the greater likelihood they will have a more severe influenza-related illness. They also may be more likely to seek medical help for a fever or ARI and may be more likely to be hospitalized because of concerns about their risk of asthma exacerbations, the investigators noted.

Vaccination rates were low in both groups: About 27% of those children with asthma had been vaccinated, and 12%–15% of the children without asthma had been vaccinated, according to parent reports. “Targeted strategies to increase the influenza vaccination rates for both children with asthma and healthy children [aged] 6–59 months are needed,” the researchers said.

ReadyMed elastomeric infusion pumps should not be used to deliver the antibiotic daptomycin (Cubicin) because of a “potentially significant impurity” that has been identified in the antibiotic when stored in this particular pump, according to the Food and Drug Administration and manufacturer of the antibiotic.

In a notice posted on the FDA's MedWatch site, the FDA announced that 2-mercaptobenzothiazole (MBT) has been isolated from reconstituted Cubicin stored in the ReadyMed infusion pumps, which are manufactured by Cardinal Health Inc. MBT is used to manufacture rubber, “and has been reported to leach from rubber stoppers and syringe components into medicinal products in the past,” the FDA said.

However, no MBT has been found in reconstituted Cubicin in other standard infusion systems that have been tested.

Daptomycin for injection is marketed as Cubicin by Cubist Pharmaceuticals Inc. In a letter to health care professionals, the company advised against the use of the ReadyMed pumps “until this issue is addressed.”

The lab studies that detected MBT in samples of daptomycin stored in the ReadyMed pumps examined the stability of daptomycin reconstituted in 0.9% sodium chloride for injection and stored in the pumps at a concentration of 20 mg/mL for at least 10 days in refrigerated conditions. The company also did not detect MBT in samples of daptomycin stored in Eclipse pumps, another elastomeric infusion pump manufactured by the I-Flow Corp., but has not evaluated its stability in other elastomeric infusion pumps.

“The clinical significance of this finding is unknown,” according to the letter. Neither the letter nor the FDA mentions any reports of adverse events in patients associated with this finding. But the letter also says that cutaneous exposure to MBT has been associated with dermal sensitization, and that chronic administration of MBT has been associated with an increased risk of certain tumors in laboratory rodents.

Cubist Pharmaceuticals can be contacted at 866-793-2786. The MedWatch notice is available at www.fda.gov/medwatch/safety/2008/safety08.htm#cubicinwww.fda.gov/medwatch

ReadyMed elastomeric infusion pumps should not be used to deliver the antibiotic daptomycin (Cubicin) because of a “potentially significant impurity” that has been identified in the antibiotic when stored in this particular pump, according to the Food and Drug Administration and manufacturer of the antibiotic.

In a notice posted on the FDA's MedWatch site, the FDA announced that 2-mercaptobenzothiazole (MBT) has been isolated from reconstituted Cubicin stored in the ReadyMed infusion pumps, which are manufactured by Cardinal Health Inc. MBT is used to manufacture rubber, “and has been reported to leach from rubber stoppers and syringe components into medicinal products in the past,” the FDA said.

However, no MBT has been found in reconstituted Cubicin in other standard infusion systems that have been tested.

Daptomycin for injection is marketed as Cubicin by Cubist Pharmaceuticals Inc. In a letter to health care professionals, the company advised against the use of the ReadyMed pumps “until this issue is addressed.”

The lab studies that detected MBT in samples of daptomycin stored in the ReadyMed pumps examined the stability of daptomycin reconstituted in 0.9% sodium chloride for injection and stored in the pumps at a concentration of 20 mg/mL for at least 10 days in refrigerated conditions. The company also did not detect MBT in samples of daptomycin stored in Eclipse pumps, another elastomeric infusion pump manufactured by the I-Flow Corp., but has not evaluated its stability in other elastomeric infusion pumps.

“The clinical significance of this finding is unknown,” according to the letter. Neither the letter nor the FDA mentions any reports of adverse events in patients associated with this finding. But the letter also says that cutaneous exposure to MBT has been associated with dermal sensitization, and that chronic administration of MBT has been associated with an increased risk of certain tumors in laboratory rodents.

Cubist Pharmaceuticals can be contacted at 866-793-2786. The MedWatch notice is available at www.fda.gov/medwatch/safety/2008/safety08.htm#cubicinwww.fda.gov/medwatch

ReadyMed elastomeric infusion pumps should not be used to deliver the antibiotic daptomycin (Cubicin) because of a “potentially significant impurity” that has been identified in the antibiotic when stored in this particular pump, according to the Food and Drug Administration and manufacturer of the antibiotic.

In a notice posted on the FDA's MedWatch site, the FDA announced that 2-mercaptobenzothiazole (MBT) has been isolated from reconstituted Cubicin stored in the ReadyMed infusion pumps, which are manufactured by Cardinal Health Inc. MBT is used to manufacture rubber, “and has been reported to leach from rubber stoppers and syringe components into medicinal products in the past,” the FDA said.

However, no MBT has been found in reconstituted Cubicin in other standard infusion systems that have been tested.

Daptomycin for injection is marketed as Cubicin by Cubist Pharmaceuticals Inc. In a letter to health care professionals, the company advised against the use of the ReadyMed pumps “until this issue is addressed.”

The lab studies that detected MBT in samples of daptomycin stored in the ReadyMed pumps examined the stability of daptomycin reconstituted in 0.9% sodium chloride for injection and stored in the pumps at a concentration of 20 mg/mL for at least 10 days in refrigerated conditions. The company also did not detect MBT in samples of daptomycin stored in Eclipse pumps, another elastomeric infusion pump manufactured by the I-Flow Corp., but has not evaluated its stability in other elastomeric infusion pumps.

“The clinical significance of this finding is unknown,” according to the letter. Neither the letter nor the FDA mentions any reports of adverse events in patients associated with this finding. But the letter also says that cutaneous exposure to MBT has been associated with dermal sensitization, and that chronic administration of MBT has been associated with an increased risk of certain tumors in laboratory rodents.

Cubist Pharmaceuticals can be contacted at 866-793-2786. The MedWatch notice is available at www.fda.gov/medwatch/safety/2008/safety08.htm#cubicinwww.fda.gov/medwatch