Families are the bedrock of the lives of many, but some people opt to separate permanently from family members. A recent episode of the NPR program “1A” explored why families sever ties.

JodiJacobson/Stockphoto.com

For journalist Harriet Brown, author of “Shadow Daughter: A Memoir of Estrangement,” (Da Capo Press, 2018), the decision to end her relationship with her mother came after she blamed Ms. Brown in “a blistering email” for the relapsed anorexia of Ms. Brown’s daughter.

“I was done with her,” Ms. Brown said on the program. “I told her I was done. That was it. And I never talked to her again. I think for both of us it felt final in some way.”

She said a lot of shame and stigma comes from having a bad relationship with a parent. “I really wanted to make it clear that ... sometimes walking away is really the best thing to do.”

Kristina M. Scharp, PhD, who has studied the estrangement phenomenon, said no national data exist on family estrangement. “About 12% of mothers and research would suggest even more fathers would report being estranged from one of their children,” said Dr. Scharp, who is with the University of Washington, Seattle. “It’s fairly common.”

Estrangement might be more common today because times have changed, said Joshua Coleman, PhD, author of “When Parents Hurt: Compassionate Strategies When you and Your Grown Child Don’t get Along” (HarperCollins, 2008). “Today’s adult children don’t view their relationships with their parents the way their folks did with their parents … the principles of obligation, duty, and respect that baby boomers and generations before them had for their elders aren’t necessarily there anymore,” Dr. Coleman said in a previous interview with the Chicago Tribune.

For her part, Ms. Brown said, the relationship with her mother – who is now deceased – might have been healed with respect. That respect would have looked like “acknowledging that we were different people,” she said. “Honestly, it was that basic with my mother.”

Phelps gets mental health advocacy award

In the pool, Michael Phelps was golden, with 28 Olympics medals, 23 of them gold, hanging around his neck by the end of his swimming career. But the release from the water to real life after the 2016 Summer Olympics left no outlet for troubles that had dogged him for years. Drunk driving convictions and a ban from competition during his competitive years had failed to stop his downward spiral of depression. His thoughts turned to suicide.

But his story has a bright ending. With his realization that he had hit rock bottom, and with the help of his wife and therapists, he accepted his depression and learned to live with the reality that his life is, for the most part, pretty good.

His openness about his struggles with depression has been influential. The latest recognition came in early January, when he received the Morton E. Ruderman Award in Inclusion from the Ruderman Family Foundation. As reported in the Boston Globe, Mr. Phelps was recognized for his advocacy for people with disabilities and “his own journey with mental health.”

“I do like who I am and I’m comfortable with who I am. I couldn’t say that a few years ago. So I’m in a very good place and just living life one day at a time,” Mr. Phelps remarked in an interview with CNN last year.

Mr. Phelps is now a paid spokesperson for TalkSpace, an online therapy company.

“I’d like to make a difference. I’d like to be able to save a life if I can. You know, for me that’s more important than winning a gold medal. The stuff that I’m doing now is very exciting. It’s hard, it’s challenging but it’s fun for me. That’s what drives me to get out of bed every morning,” he said.

Offenders with mental illness get a break

A law included as part of budget legislation that was signed by then-Gov. Jerry Brown of California in June 2018 has offered people with mental health troubles who have been charged with a crime the opportunity for treatment instead of jail time.

As reported in the Los Angeles Times, the law provides judges with the discretion to order offenders into treatment rather than sentencing them. Success in treatment can lead to charges being dropped.

The law has been praised by some mental health advocates but panned by law enforcement officials and prosecutors with a harder view of criminal justice. The opposition stems largely from a December 2018 ruling by the 4th District Court of Appeal that the law could be applied to retroactively address the case of a man imprisoned for 29 years in 2017 for multiple felony charges that included domestic violence and assault.

The law does not extend to those charged with murder, manslaughter, rape, and child sexual abuse. To date, citing mental illness in seeking diversion of sentencing has not proven successful in most cases.

Schools get mental health allocation

The Orleans Parish School Board, which serves all of New Orleans, will allocate $1.3 million to the Center for Resilience, a local mental health day treatment program, beginning this year. The new program will expand mental health help to children in grades 9-12, according to a report in the Times-Picayune.

The funding will enable the center to expand an existing program that helps students with behavioral issues. Such help is not available in the traditional school system. By offsetting part of the price tag for the mental health care, the initiative “[helps to make] this critical service more available for our students most in need,” said Dominique Ellis, a spokesperson for the school board. “Mental health day treatment programs like the Center for Resilience typically cost between the ranges of $80,000-$100,000 per student to operate effectively.”

The development brings New Orleans level with money spent on similar programs in other school boards nationwide. It’s a service that is sorely needed. According to statistics supplied by the Center for Resilience, 60% of New Orleans children suffer from PTSD and are 4.5 times more likely to suffer from hyperactivity, aggression, and social withdrawal than similarly aged children elsewhere in the United States.

Bill addressing opioid crisis a “no-brainer”

Legislation put forward in the current session of the Texas Legislature would require pharmacists to identify all prescription opioids with a red cap and a hard-to-miss warning of the addictive risk of the medications. In addition, pharmacists would have to explain the risk in person to those receiving the medications and get signed acknowledgment of the conversation before dispensing the drugs.

As described in an article in the Austin American-Stateman, nearly 3,000 people in Texas died from drug overdoses in 2017. The deaths tied to opioid overdoses are not certain, but other data from 2015 suggest that one-third is a reasonable estimate.

“Losing a loved one to an opioid overdose is a tragedy that far too many Texas families experience,” said Rep. Shawn Thierry last month, when she introduced the three bills. “These distinctive red caps will serve as a clear notice to Texans that opioids are unlike milder forms of prescription pain relievers and have life-altering risks that must be considered before taking them.”

Warning labels on everything from food to tobacco products, and including them on prescription opioids is a “no-brainer,” Ms. Thierry said. “The more we can educate our residents the less likely they will be to misuse these medications.”

A report issued in November 2018 chronicled the drug crisis in Texas and offered recommendations. Many of the 100 recommendations involved the absence of treatment resources in the state.

Families are the bedrock of the lives of many, but some people opt to separate permanently from family members. A recent episode of the NPR program “1A” explored why families sever ties.

JodiJacobson/Stockphoto.com

For journalist Harriet Brown, author of “Shadow Daughter: A Memoir of Estrangement,” (Da Capo Press, 2018), the decision to end her relationship with her mother came after she blamed Ms. Brown in “a blistering email” for the relapsed anorexia of Ms. Brown’s daughter.

“I was done with her,” Ms. Brown said on the program. “I told her I was done. That was it. And I never talked to her again. I think for both of us it felt final in some way.”

She said a lot of shame and stigma comes from having a bad relationship with a parent. “I really wanted to make it clear that ... sometimes walking away is really the best thing to do.”

Kristina M. Scharp, PhD, who has studied the estrangement phenomenon, said no national data exist on family estrangement. “About 12% of mothers and research would suggest even more fathers would report being estranged from one of their children,” said Dr. Scharp, who is with the University of Washington, Seattle. “It’s fairly common.”

Estrangement might be more common today because times have changed, said Joshua Coleman, PhD, author of “When Parents Hurt: Compassionate Strategies When you and Your Grown Child Don’t get Along” (HarperCollins, 2008). “Today’s adult children don’t view their relationships with their parents the way their folks did with their parents … the principles of obligation, duty, and respect that baby boomers and generations before them had for their elders aren’t necessarily there anymore,” Dr. Coleman said in a previous interview with the Chicago Tribune.

For her part, Ms. Brown said, the relationship with her mother – who is now deceased – might have been healed with respect. That respect would have looked like “acknowledging that we were different people,” she said. “Honestly, it was that basic with my mother.”

Phelps gets mental health advocacy award

In the pool, Michael Phelps was golden, with 28 Olympics medals, 23 of them gold, hanging around his neck by the end of his swimming career. But the release from the water to real life after the 2016 Summer Olympics left no outlet for troubles that had dogged him for years. Drunk driving convictions and a ban from competition during his competitive years had failed to stop his downward spiral of depression. His thoughts turned to suicide.

But his story has a bright ending. With his realization that he had hit rock bottom, and with the help of his wife and therapists, he accepted his depression and learned to live with the reality that his life is, for the most part, pretty good.

His openness about his struggles with depression has been influential. The latest recognition came in early January, when he received the Morton E. Ruderman Award in Inclusion from the Ruderman Family Foundation. As reported in the Boston Globe, Mr. Phelps was recognized for his advocacy for people with disabilities and “his own journey with mental health.”

“I do like who I am and I’m comfortable with who I am. I couldn’t say that a few years ago. So I’m in a very good place and just living life one day at a time,” Mr. Phelps remarked in an interview with CNN last year.

Mr. Phelps is now a paid spokesperson for TalkSpace, an online therapy company.

“I’d like to make a difference. I’d like to be able to save a life if I can. You know, for me that’s more important than winning a gold medal. The stuff that I’m doing now is very exciting. It’s hard, it’s challenging but it’s fun for me. That’s what drives me to get out of bed every morning,” he said.

Offenders with mental illness get a break

A law included as part of budget legislation that was signed by then-Gov. Jerry Brown of California in June 2018 has offered people with mental health troubles who have been charged with a crime the opportunity for treatment instead of jail time.

As reported in the Los Angeles Times, the law provides judges with the discretion to order offenders into treatment rather than sentencing them. Success in treatment can lead to charges being dropped.

The law has been praised by some mental health advocates but panned by law enforcement officials and prosecutors with a harder view of criminal justice. The opposition stems largely from a December 2018 ruling by the 4th District Court of Appeal that the law could be applied to retroactively address the case of a man imprisoned for 29 years in 2017 for multiple felony charges that included domestic violence and assault.

The law does not extend to those charged with murder, manslaughter, rape, and child sexual abuse. To date, citing mental illness in seeking diversion of sentencing has not proven successful in most cases.

Schools get mental health allocation

The Orleans Parish School Board, which serves all of New Orleans, will allocate $1.3 million to the Center for Resilience, a local mental health day treatment program, beginning this year. The new program will expand mental health help to children in grades 9-12, according to a report in the Times-Picayune.

The funding will enable the center to expand an existing program that helps students with behavioral issues. Such help is not available in the traditional school system. By offsetting part of the price tag for the mental health care, the initiative “[helps to make] this critical service more available for our students most in need,” said Dominique Ellis, a spokesperson for the school board. “Mental health day treatment programs like the Center for Resilience typically cost between the ranges of $80,000-$100,000 per student to operate effectively.”

The development brings New Orleans level with money spent on similar programs in other school boards nationwide. It’s a service that is sorely needed. According to statistics supplied by the Center for Resilience, 60% of New Orleans children suffer from PTSD and are 4.5 times more likely to suffer from hyperactivity, aggression, and social withdrawal than similarly aged children elsewhere in the United States.

Bill addressing opioid crisis a “no-brainer”

Legislation put forward in the current session of the Texas Legislature would require pharmacists to identify all prescription opioids with a red cap and a hard-to-miss warning of the addictive risk of the medications. In addition, pharmacists would have to explain the risk in person to those receiving the medications and get signed acknowledgment of the conversation before dispensing the drugs.

As described in an article in the Austin American-Stateman, nearly 3,000 people in Texas died from drug overdoses in 2017. The deaths tied to opioid overdoses are not certain, but other data from 2015 suggest that one-third is a reasonable estimate.

“Losing a loved one to an opioid overdose is a tragedy that far too many Texas families experience,” said Rep. Shawn Thierry last month, when she introduced the three bills. “These distinctive red caps will serve as a clear notice to Texans that opioids are unlike milder forms of prescription pain relievers and have life-altering risks that must be considered before taking them.”

Warning labels on everything from food to tobacco products, and including them on prescription opioids is a “no-brainer,” Ms. Thierry said. “The more we can educate our residents the less likely they will be to misuse these medications.”

A report issued in November 2018 chronicled the drug crisis in Texas and offered recommendations. Many of the 100 recommendations involved the absence of treatment resources in the state.

Families are the bedrock of the lives of many, but some people opt to separate permanently from family members. A recent episode of the NPR program “1A” explored why families sever ties.

JodiJacobson/Stockphoto.com

For journalist Harriet Brown, author of “Shadow Daughter: A Memoir of Estrangement,” (Da Capo Press, 2018), the decision to end her relationship with her mother came after she blamed Ms. Brown in “a blistering email” for the relapsed anorexia of Ms. Brown’s daughter.

“I was done with her,” Ms. Brown said on the program. “I told her I was done. That was it. And I never talked to her again. I think for both of us it felt final in some way.”

She said a lot of shame and stigma comes from having a bad relationship with a parent. “I really wanted to make it clear that ... sometimes walking away is really the best thing to do.”

Kristina M. Scharp, PhD, who has studied the estrangement phenomenon, said no national data exist on family estrangement. “About 12% of mothers and research would suggest even more fathers would report being estranged from one of their children,” said Dr. Scharp, who is with the University of Washington, Seattle. “It’s fairly common.”

Estrangement might be more common today because times have changed, said Joshua Coleman, PhD, author of “When Parents Hurt: Compassionate Strategies When you and Your Grown Child Don’t get Along” (HarperCollins, 2008). “Today’s adult children don’t view their relationships with their parents the way their folks did with their parents … the principles of obligation, duty, and respect that baby boomers and generations before them had for their elders aren’t necessarily there anymore,” Dr. Coleman said in a previous interview with the Chicago Tribune.

For her part, Ms. Brown said, the relationship with her mother – who is now deceased – might have been healed with respect. That respect would have looked like “acknowledging that we were different people,” she said. “Honestly, it was that basic with my mother.”

Phelps gets mental health advocacy award

In the pool, Michael Phelps was golden, with 28 Olympics medals, 23 of them gold, hanging around his neck by the end of his swimming career. But the release from the water to real life after the 2016 Summer Olympics left no outlet for troubles that had dogged him for years. Drunk driving convictions and a ban from competition during his competitive years had failed to stop his downward spiral of depression. His thoughts turned to suicide.

But his story has a bright ending. With his realization that he had hit rock bottom, and with the help of his wife and therapists, he accepted his depression and learned to live with the reality that his life is, for the most part, pretty good.

His openness about his struggles with depression has been influential. The latest recognition came in early January, when he received the Morton E. Ruderman Award in Inclusion from the Ruderman Family Foundation. As reported in the Boston Globe, Mr. Phelps was recognized for his advocacy for people with disabilities and “his own journey with mental health.”

“I do like who I am and I’m comfortable with who I am. I couldn’t say that a few years ago. So I’m in a very good place and just living life one day at a time,” Mr. Phelps remarked in an interview with CNN last year.

Mr. Phelps is now a paid spokesperson for TalkSpace, an online therapy company.

“I’d like to make a difference. I’d like to be able to save a life if I can. You know, for me that’s more important than winning a gold medal. The stuff that I’m doing now is very exciting. It’s hard, it’s challenging but it’s fun for me. That’s what drives me to get out of bed every morning,” he said.

Offenders with mental illness get a break

A law included as part of budget legislation that was signed by then-Gov. Jerry Brown of California in June 2018 has offered people with mental health troubles who have been charged with a crime the opportunity for treatment instead of jail time.

As reported in the Los Angeles Times, the law provides judges with the discretion to order offenders into treatment rather than sentencing them. Success in treatment can lead to charges being dropped.

The law has been praised by some mental health advocates but panned by law enforcement officials and prosecutors with a harder view of criminal justice. The opposition stems largely from a December 2018 ruling by the 4th District Court of Appeal that the law could be applied to retroactively address the case of a man imprisoned for 29 years in 2017 for multiple felony charges that included domestic violence and assault.

The law does not extend to those charged with murder, manslaughter, rape, and child sexual abuse. To date, citing mental illness in seeking diversion of sentencing has not proven successful in most cases.

Schools get mental health allocation

The Orleans Parish School Board, which serves all of New Orleans, will allocate $1.3 million to the Center for Resilience, a local mental health day treatment program, beginning this year. The new program will expand mental health help to children in grades 9-12, according to a report in the Times-Picayune.

The funding will enable the center to expand an existing program that helps students with behavioral issues. Such help is not available in the traditional school system. By offsetting part of the price tag for the mental health care, the initiative “[helps to make] this critical service more available for our students most in need,” said Dominique Ellis, a spokesperson for the school board. “Mental health day treatment programs like the Center for Resilience typically cost between the ranges of $80,000-$100,000 per student to operate effectively.”

The development brings New Orleans level with money spent on similar programs in other school boards nationwide. It’s a service that is sorely needed. According to statistics supplied by the Center for Resilience, 60% of New Orleans children suffer from PTSD and are 4.5 times more likely to suffer from hyperactivity, aggression, and social withdrawal than similarly aged children elsewhere in the United States.

Bill addressing opioid crisis a “no-brainer”

Legislation put forward in the current session of the Texas Legislature would require pharmacists to identify all prescription opioids with a red cap and a hard-to-miss warning of the addictive risk of the medications. In addition, pharmacists would have to explain the risk in person to those receiving the medications and get signed acknowledgment of the conversation before dispensing the drugs.

As described in an article in the Austin American-Stateman, nearly 3,000 people in Texas died from drug overdoses in 2017. The deaths tied to opioid overdoses are not certain, but other data from 2015 suggest that one-third is a reasonable estimate.

“Losing a loved one to an opioid overdose is a tragedy that far too many Texas families experience,” said Rep. Shawn Thierry last month, when she introduced the three bills. “These distinctive red caps will serve as a clear notice to Texans that opioids are unlike milder forms of prescription pain relievers and have life-altering risks that must be considered before taking them.”

Warning labels on everything from food to tobacco products, and including them on prescription opioids is a “no-brainer,” Ms. Thierry said. “The more we can educate our residents the less likely they will be to misuse these medications.”

A report issued in November 2018 chronicled the drug crisis in Texas and offered recommendations. Many of the 100 recommendations involved the absence of treatment resources in the state.

A decrease in the expression of two long noncoding RNAs in the factor VIII gene may explain the development of severe hemophilia, according to an analysis recently published in Hematology.

Researchers at the Iranian Comprehensive Hemophilia Care Center in Tehran identified two long noncoding RNAs for investigation – NONHSAT139219.2 and NONHSAT139215.2. They collected 5 mL of venous blood from 50 males with severe hemophilia A and 50 healthy male donors and analyzed the RNA expression.

The mean of the transcript levels of two long noncoding RNAs was significantly lower in the hemophilia A samples, compared with the normal samples – 5.52 for controls versus 1.25 for hemophilia A for NONHSAT139215 and 4.86 for controls versus 2.14 for hemophilia A samples for NONHSAT139219 (P less than .05).

Low expression levels of long noncoding RNAs in severe hemophilia A cases may be linked with the reduction of factor VIII levels, according to the investigators. “It is possible that the transcription of [long noncoding] RNAs leads to gene silencing or activation.”

This provides a potential biomarker with application in both prognosis and therapeutics; long noncoding RNA functional analysis should be performed in future studies, they wrote.

There was no outside funding for the study, and no potential conflict of interest was reported by the authors.

mschneider@mdedge.com

SOURCE: Niloofar N et al. Hematology. 2019;24(1):255-62.

A decrease in the expression of two long noncoding RNAs in the factor VIII gene may explain the development of severe hemophilia, according to an analysis recently published in Hematology.

Researchers at the Iranian Comprehensive Hemophilia Care Center in Tehran identified two long noncoding RNAs for investigation – NONHSAT139219.2 and NONHSAT139215.2. They collected 5 mL of venous blood from 50 males with severe hemophilia A and 50 healthy male donors and analyzed the RNA expression.

The mean of the transcript levels of two long noncoding RNAs was significantly lower in the hemophilia A samples, compared with the normal samples – 5.52 for controls versus 1.25 for hemophilia A for NONHSAT139215 and 4.86 for controls versus 2.14 for hemophilia A samples for NONHSAT139219 (P less than .05).

Low expression levels of long noncoding RNAs in severe hemophilia A cases may be linked with the reduction of factor VIII levels, according to the investigators. “It is possible that the transcription of [long noncoding] RNAs leads to gene silencing or activation.”

This provides a potential biomarker with application in both prognosis and therapeutics; long noncoding RNA functional analysis should be performed in future studies, they wrote.

There was no outside funding for the study, and no potential conflict of interest was reported by the authors.

mschneider@mdedge.com

SOURCE: Niloofar N et al. Hematology. 2019;24(1):255-62.

A decrease in the expression of two long noncoding RNAs in the factor VIII gene may explain the development of severe hemophilia, according to an analysis recently published in Hematology.

Researchers at the Iranian Comprehensive Hemophilia Care Center in Tehran identified two long noncoding RNAs for investigation – NONHSAT139219.2 and NONHSAT139215.2. They collected 5 mL of venous blood from 50 males with severe hemophilia A and 50 healthy male donors and analyzed the RNA expression.

The mean of the transcript levels of two long noncoding RNAs was significantly lower in the hemophilia A samples, compared with the normal samples – 5.52 for controls versus 1.25 for hemophilia A for NONHSAT139215 and 4.86 for controls versus 2.14 for hemophilia A samples for NONHSAT139219 (P less than .05).

Low expression levels of long noncoding RNAs in severe hemophilia A cases may be linked with the reduction of factor VIII levels, according to the investigators. “It is possible that the transcription of [long noncoding] RNAs leads to gene silencing or activation.”

This provides a potential biomarker with application in both prognosis and therapeutics; long noncoding RNA functional analysis should be performed in future studies, they wrote.

There was no outside funding for the study, and no potential conflict of interest was reported by the authors.

mschneider@mdedge.com

SOURCE: Niloofar N et al. Hematology. 2019;24(1):255-62.

Point-of-care intrapartum molecular screening of group B Streptococcus reduced the incidence of early-onset disease cases and antibiotic use, according to research published in Obstetrics & Gynecology.

James Gathany/CDC

Najoua El Helali, PharmD, from the Service de Microbiologie Clinique at Groupe Hospitalier Paris Saint-Joseph, and her colleagues measured the rate of early-onset disease group B Streptococcus (GBS) in a single-center study analyzing antenatal culture screening for 4 years prior to implementation (2006-2009) of polymerase chain reaction (PCR) screening (2010-2015). There were 11,226 deliveries (11,818 live births) during the antenatal screening period and 18,835 deliveries (18,980 live births) during the PCR screening period. Overall, 4% of deliveries during the antenatal period and 0.1% of deliveries during the intrapartum period were not screened for GBS (P less than .001).

During 2006-2015, the rate of early-onset disease of GBS decreased to 0.21/1,000 cases from 1.01/1,000 cases (risk ratio, 0.25; 95% confidence interval, 0.14-0.43; P = .026), while the rate of probable early-onset disease GBS decreased to 0.73/1,000 cases from 2.8/1,000 cases (RR, 0.25; (95% CI, 0.14-0.43; P less than .001).

For patients with early-onset GBS, length of stay in hospital decreased by 64%, and antibiotic therapy decreased by 60%, but there was no significant difference in average length of stay or duration of antibiotic therapy during the study period. There was a reduction in annual delivery- and treatment-associated costs of early-onset disease GBS from $41,875 to $11,945, while the estimated extra cost of PCR screening to avoid one additional case of early-onset disease GBS was $5,819 and a cost increase of $49 per newborn.

“The additional PCR costs were offset in part by the reduction in early-onset GBS disease treatment costs,” the investigators said.

“A randomized, controlled multicenter study is probably needed to evaluate the cost-effectiveness of this prevention strategy and demonstrate a better efficacy in populations where poorly followed women are of unknown GBS status at presentation for delivery,” the researchers said. “In term newborns, however, using infection rate as an endpoint is problematic given the sample size needed.”

The researchers said their study was potentially limited by lack of a control group and population selection, and described mothers in their center as “mostly well-informed and well-monitored during their pregnancy.”

The authors reported no relevant conflicts of interest.

SOURCE: El Helali N et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003057.

Point-of-care intrapartum molecular screening of group B Streptococcus reduced the incidence of early-onset disease cases and antibiotic use, according to research published in Obstetrics & Gynecology.

James Gathany/CDC

Najoua El Helali, PharmD, from the Service de Microbiologie Clinique at Groupe Hospitalier Paris Saint-Joseph, and her colleagues measured the rate of early-onset disease group B Streptococcus (GBS) in a single-center study analyzing antenatal culture screening for 4 years prior to implementation (2006-2009) of polymerase chain reaction (PCR) screening (2010-2015). There were 11,226 deliveries (11,818 live births) during the antenatal screening period and 18,835 deliveries (18,980 live births) during the PCR screening period. Overall, 4% of deliveries during the antenatal period and 0.1% of deliveries during the intrapartum period were not screened for GBS (P less than .001).

During 2006-2015, the rate of early-onset disease of GBS decreased to 0.21/1,000 cases from 1.01/1,000 cases (risk ratio, 0.25; 95% confidence interval, 0.14-0.43; P = .026), while the rate of probable early-onset disease GBS decreased to 0.73/1,000 cases from 2.8/1,000 cases (RR, 0.25; (95% CI, 0.14-0.43; P less than .001).

For patients with early-onset GBS, length of stay in hospital decreased by 64%, and antibiotic therapy decreased by 60%, but there was no significant difference in average length of stay or duration of antibiotic therapy during the study period. There was a reduction in annual delivery- and treatment-associated costs of early-onset disease GBS from $41,875 to $11,945, while the estimated extra cost of PCR screening to avoid one additional case of early-onset disease GBS was $5,819 and a cost increase of $49 per newborn.

“The additional PCR costs were offset in part by the reduction in early-onset GBS disease treatment costs,” the investigators said.

“A randomized, controlled multicenter study is probably needed to evaluate the cost-effectiveness of this prevention strategy and demonstrate a better efficacy in populations where poorly followed women are of unknown GBS status at presentation for delivery,” the researchers said. “In term newborns, however, using infection rate as an endpoint is problematic given the sample size needed.”

The researchers said their study was potentially limited by lack of a control group and population selection, and described mothers in their center as “mostly well-informed and well-monitored during their pregnancy.”

The authors reported no relevant conflicts of interest.

SOURCE: El Helali N et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003057.

Point-of-care intrapartum molecular screening of group B Streptococcus reduced the incidence of early-onset disease cases and antibiotic use, according to research published in Obstetrics & Gynecology.

James Gathany/CDC

Najoua El Helali, PharmD, from the Service de Microbiologie Clinique at Groupe Hospitalier Paris Saint-Joseph, and her colleagues measured the rate of early-onset disease group B Streptococcus (GBS) in a single-center study analyzing antenatal culture screening for 4 years prior to implementation (2006-2009) of polymerase chain reaction (PCR) screening (2010-2015). There were 11,226 deliveries (11,818 live births) during the antenatal screening period and 18,835 deliveries (18,980 live births) during the PCR screening period. Overall, 4% of deliveries during the antenatal period and 0.1% of deliveries during the intrapartum period were not screened for GBS (P less than .001).

During 2006-2015, the rate of early-onset disease of GBS decreased to 0.21/1,000 cases from 1.01/1,000 cases (risk ratio, 0.25; 95% confidence interval, 0.14-0.43; P = .026), while the rate of probable early-onset disease GBS decreased to 0.73/1,000 cases from 2.8/1,000 cases (RR, 0.25; (95% CI, 0.14-0.43; P less than .001).

For patients with early-onset GBS, length of stay in hospital decreased by 64%, and antibiotic therapy decreased by 60%, but there was no significant difference in average length of stay or duration of antibiotic therapy during the study period. There was a reduction in annual delivery- and treatment-associated costs of early-onset disease GBS from $41,875 to $11,945, while the estimated extra cost of PCR screening to avoid one additional case of early-onset disease GBS was $5,819 and a cost increase of $49 per newborn.

“The additional PCR costs were offset in part by the reduction in early-onset GBS disease treatment costs,” the investigators said.

“A randomized, controlled multicenter study is probably needed to evaluate the cost-effectiveness of this prevention strategy and demonstrate a better efficacy in populations where poorly followed women are of unknown GBS status at presentation for delivery,” the researchers said. “In term newborns, however, using infection rate as an endpoint is problematic given the sample size needed.”

The researchers said their study was potentially limited by lack of a control group and population selection, and described mothers in their center as “mostly well-informed and well-monitored during their pregnancy.”

The authors reported no relevant conflicts of interest.

SOURCE: El Helali N et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003057.

Topical ionic contraviral therapy decreased the size of cutaneous warts caused by human papillomavirus virus (HPV) by a mean of 3 mm, a significant improvement compared with placebo, in a proof-of-concept study, Dr. Melanie Rijsbergen and her associates reported in the British Journal of Dermatology.

The mean HPV load also declined by 94% in warts treated with the treatment, a combination of digoxin and furosemide in a topical gel, Dr. Rijsbergen of the Center for Human Drug Research, Leiden, the Netherlands, and her coauthors wrote.

“It has been shown that DNA viruses, such as HPV, rely on potassium influx ... for replication. The cardiac glycoside digoxin and loop diuretic furosemide both inhibit potassium influx by interacting with the cell membrane ion cotransporters,” they said, noting that in 2006, an in vitro study found that “the inhibitory effect on DNA replication was most potent when digoxin and furosemide were combined.”

The placebo-controlled phase 2a trial randomized 80 patients with at least two plantar or common warts to one of four arms: digoxin 0.125% plus furosemide 0.125%; digoxin 0.125%; furosemide 0.125%; or placebo applied once a day for 42 consecutive days. A subset of 20 warts underwent histopathology and immunohistochemistry. In all, 139 warts were treated.


Patients were a mean of 26 years old and had developed warts a mean of 6 years before study onset. They had a mean of three warts each; about half were common and half were plantar.

In an analysis of all treated warts, each active treatment conferred a significant benefit, compared with placebo. The combination treatment was the most effective, with a mean diameter reduction of 3 mm. Warts exposed to digoxin alone or furosemide alone showed a mean reduction of about 2 mm.

At the study’s end, primary wart clearance rates were similar in all treatment groups – around 15%. None of the primary warts in the placebo group cleared. Common warts were more responsive to treatment than were plantar warts (24%-27% vs. 8%-15%). “The increased treatment resistance of plantar warts was previously described and seems to be mainly due to callus formation resulting in a decrease in cutaneous permeability of a drug,” the authors wrote.

The HPV viral load decreased by 94% in warts exposed to the combination therapy – a significant benefit, compared with placebo.

There were no discontinuations because of adverse events, and no serious adverse events related to treatment. There was no topical irritation associated with the treatment.

One author is an employee of Cutanea Life Sciences, which funded the study. Dr. Rijsbergen and the remaining authors declared no financial conflicts.

msullivan@mdedge.com

SOURCE: Rijsbergen M et al. Br J Dermatol. 2018 Dec 22. doi: 10.1111/bjd.17583.

Topical ionic contraviral therapy decreased the size of cutaneous warts caused by human papillomavirus virus (HPV) by a mean of 3 mm, a significant improvement compared with placebo, in a proof-of-concept study, Dr. Melanie Rijsbergen and her associates reported in the British Journal of Dermatology.

The mean HPV load also declined by 94% in warts treated with the treatment, a combination of digoxin and furosemide in a topical gel, Dr. Rijsbergen of the Center for Human Drug Research, Leiden, the Netherlands, and her coauthors wrote.

“It has been shown that DNA viruses, such as HPV, rely on potassium influx ... for replication. The cardiac glycoside digoxin and loop diuretic furosemide both inhibit potassium influx by interacting with the cell membrane ion cotransporters,” they said, noting that in 2006, an in vitro study found that “the inhibitory effect on DNA replication was most potent when digoxin and furosemide were combined.”

The placebo-controlled phase 2a trial randomized 80 patients with at least two plantar or common warts to one of four arms: digoxin 0.125% plus furosemide 0.125%; digoxin 0.125%; furosemide 0.125%; or placebo applied once a day for 42 consecutive days. A subset of 20 warts underwent histopathology and immunohistochemistry. In all, 139 warts were treated.


Patients were a mean of 26 years old and had developed warts a mean of 6 years before study onset. They had a mean of three warts each; about half were common and half were plantar.

In an analysis of all treated warts, each active treatment conferred a significant benefit, compared with placebo. The combination treatment was the most effective, with a mean diameter reduction of 3 mm. Warts exposed to digoxin alone or furosemide alone showed a mean reduction of about 2 mm.

At the study’s end, primary wart clearance rates were similar in all treatment groups – around 15%. None of the primary warts in the placebo group cleared. Common warts were more responsive to treatment than were plantar warts (24%-27% vs. 8%-15%). “The increased treatment resistance of plantar warts was previously described and seems to be mainly due to callus formation resulting in a decrease in cutaneous permeability of a drug,” the authors wrote.

The HPV viral load decreased by 94% in warts exposed to the combination therapy – a significant benefit, compared with placebo.

There were no discontinuations because of adverse events, and no serious adverse events related to treatment. There was no topical irritation associated with the treatment.

One author is an employee of Cutanea Life Sciences, which funded the study. Dr. Rijsbergen and the remaining authors declared no financial conflicts.

msullivan@mdedge.com

SOURCE: Rijsbergen M et al. Br J Dermatol. 2018 Dec 22. doi: 10.1111/bjd.17583.

Topical ionic contraviral therapy decreased the size of cutaneous warts caused by human papillomavirus virus (HPV) by a mean of 3 mm, a significant improvement compared with placebo, in a proof-of-concept study, Dr. Melanie Rijsbergen and her associates reported in the British Journal of Dermatology.

The mean HPV load also declined by 94% in warts treated with the treatment, a combination of digoxin and furosemide in a topical gel, Dr. Rijsbergen of the Center for Human Drug Research, Leiden, the Netherlands, and her coauthors wrote.

“It has been shown that DNA viruses, such as HPV, rely on potassium influx ... for replication. The cardiac glycoside digoxin and loop diuretic furosemide both inhibit potassium influx by interacting with the cell membrane ion cotransporters,” they said, noting that in 2006, an in vitro study found that “the inhibitory effect on DNA replication was most potent when digoxin and furosemide were combined.”

The placebo-controlled phase 2a trial randomized 80 patients with at least two plantar or common warts to one of four arms: digoxin 0.125% plus furosemide 0.125%; digoxin 0.125%; furosemide 0.125%; or placebo applied once a day for 42 consecutive days. A subset of 20 warts underwent histopathology and immunohistochemistry. In all, 139 warts were treated.


Patients were a mean of 26 years old and had developed warts a mean of 6 years before study onset. They had a mean of three warts each; about half were common and half were plantar.

In an analysis of all treated warts, each active treatment conferred a significant benefit, compared with placebo. The combination treatment was the most effective, with a mean diameter reduction of 3 mm. Warts exposed to digoxin alone or furosemide alone showed a mean reduction of about 2 mm.

At the study’s end, primary wart clearance rates were similar in all treatment groups – around 15%. None of the primary warts in the placebo group cleared. Common warts were more responsive to treatment than were plantar warts (24%-27% vs. 8%-15%). “The increased treatment resistance of plantar warts was previously described and seems to be mainly due to callus formation resulting in a decrease in cutaneous permeability of a drug,” the authors wrote.

The HPV viral load decreased by 94% in warts exposed to the combination therapy – a significant benefit, compared with placebo.

There were no discontinuations because of adverse events, and no serious adverse events related to treatment. There was no topical irritation associated with the treatment.

One author is an employee of Cutanea Life Sciences, which funded the study. Dr. Rijsbergen and the remaining authors declared no financial conflicts.

msullivan@mdedge.com

SOURCE: Rijsbergen M et al. Br J Dermatol. 2018 Dec 22. doi: 10.1111/bjd.17583.

Clinical question: Does metformin increase the risk of lactic acidosis in chronic kidney disease (CKD)?

Background: Metformin is first-line therapy for type 2 diabetes mellitus (DM) because of its low cost, safety, and potential cardiovascular benefit, but fear of lactic acidosis has limited its use in CKD. The risk of acidosis in CKD patients with varying levels of renal function has not been clearly defined.

Study design: Retrospective community-based cohort study.

Setting: Geisinger Health System in Pennsylvania.

Synopsis: A total of 75,413 patients were identified with diagnostic codes or medication prescriptions indicating DM. Forty-five percent of patients were taking metformin at enrollment, increasing by 18% over the 5.7 years of median follow-up. The primary outcome was inpatient acidosis, defined by an ICD-9-CM code capturing multiple forms of acidosis but excluding diabetic ketoacidosis.

When metformin users and nonusers were compared, risk of acidosis was similar for the entire cohort and for subgroups of patients with an estimated glomerular filtration rate (eGFR) greater than 90, 60-89, 45-59, and 30-44. Conversely, metformin use was associated with a higher risk of acidosis in patients with eGFR less than 30 (adjusted hazard ratio, 2.07; 95% confidence interval, 1.33-3.22). Metformin not increasing the risk of acidosis at eGFR greater than 30 also was noted in an additional analysis using sulfonylurea medications as an active comparator and was replicated in a separate database with 82,000 patients from 350 private health systems. As with all observational studies, this study is limited by the potential for residual confounding.

Bottom line: Metformin appears to be safe in CKD patients with eGFR above 30 mL/min per 1.73 m².



Citation: Lazarus B et al. Association of metformin use with risk of lactic acidosis across the range of kidney function: A community- based cohort study. JAMA Int Med. 2018;178(7):903-10.

Dr. Wanner is director, hospital medicine section, and associate chief, division of general internal medicine, University of Utah, Salt Lake City.

Clinical question: Does metformin increase the risk of lactic acidosis in chronic kidney disease (CKD)?

Background: Metformin is first-line therapy for type 2 diabetes mellitus (DM) because of its low cost, safety, and potential cardiovascular benefit, but fear of lactic acidosis has limited its use in CKD. The risk of acidosis in CKD patients with varying levels of renal function has not been clearly defined.

Study design: Retrospective community-based cohort study.

Setting: Geisinger Health System in Pennsylvania.

Synopsis: A total of 75,413 patients were identified with diagnostic codes or medication prescriptions indicating DM. Forty-five percent of patients were taking metformin at enrollment, increasing by 18% over the 5.7 years of median follow-up. The primary outcome was inpatient acidosis, defined by an ICD-9-CM code capturing multiple forms of acidosis but excluding diabetic ketoacidosis.

When metformin users and nonusers were compared, risk of acidosis was similar for the entire cohort and for subgroups of patients with an estimated glomerular filtration rate (eGFR) greater than 90, 60-89, 45-59, and 30-44. Conversely, metformin use was associated with a higher risk of acidosis in patients with eGFR less than 30 (adjusted hazard ratio, 2.07; 95% confidence interval, 1.33-3.22). Metformin not increasing the risk of acidosis at eGFR greater than 30 also was noted in an additional analysis using sulfonylurea medications as an active comparator and was replicated in a separate database with 82,000 patients from 350 private health systems. As with all observational studies, this study is limited by the potential for residual confounding.

Bottom line: Metformin appears to be safe in CKD patients with eGFR above 30 mL/min per 1.73 m².



Citation: Lazarus B et al. Association of metformin use with risk of lactic acidosis across the range of kidney function: A community- based cohort study. JAMA Int Med. 2018;178(7):903-10.

Dr. Wanner is director, hospital medicine section, and associate chief, division of general internal medicine, University of Utah, Salt Lake City.

Clinical question: Does metformin increase the risk of lactic acidosis in chronic kidney disease (CKD)?

Background: Metformin is first-line therapy for type 2 diabetes mellitus (DM) because of its low cost, safety, and potential cardiovascular benefit, but fear of lactic acidosis has limited its use in CKD. The risk of acidosis in CKD patients with varying levels of renal function has not been clearly defined.

Study design: Retrospective community-based cohort study.

Setting: Geisinger Health System in Pennsylvania.

Synopsis: A total of 75,413 patients were identified with diagnostic codes or medication prescriptions indicating DM. Forty-five percent of patients were taking metformin at enrollment, increasing by 18% over the 5.7 years of median follow-up. The primary outcome was inpatient acidosis, defined by an ICD-9-CM code capturing multiple forms of acidosis but excluding diabetic ketoacidosis.

When metformin users and nonusers were compared, risk of acidosis was similar for the entire cohort and for subgroups of patients with an estimated glomerular filtration rate (eGFR) greater than 90, 60-89, 45-59, and 30-44. Conversely, metformin use was associated with a higher risk of acidosis in patients with eGFR less than 30 (adjusted hazard ratio, 2.07; 95% confidence interval, 1.33-3.22). Metformin not increasing the risk of acidosis at eGFR greater than 30 also was noted in an additional analysis using sulfonylurea medications as an active comparator and was replicated in a separate database with 82,000 patients from 350 private health systems. As with all observational studies, this study is limited by the potential for residual confounding.

Bottom line: Metformin appears to be safe in CKD patients with eGFR above 30 mL/min per 1.73 m².



Citation: Lazarus B et al. Association of metformin use with risk of lactic acidosis across the range of kidney function: A community- based cohort study. JAMA Int Med. 2018;178(7):903-10.

Dr. Wanner is director, hospital medicine section, and associate chief, division of general internal medicine, University of Utah, Salt Lake City.

This 80-year-old man has been complaining to health care providers about the asymptomatic lesion on his right forearm for at least 5 years—“maybe more,” he says. During that time, he has been given a variety of diagnoses, mostly “infection” of some sort, along with prescriptions for oral antibiotics (cephalexin, trimethoprim/sulfa), topical antibiotics (mupirocin, triple-antibiotic cream), and germicidal washes (povidone and others). None of these treatment attempts has achieved results.

Prior to now, there has been no referral to dermatology, nor has any provider suggested biopsy of the lesion. The patient has a history of skin cancer (basal cell or squamous cell carcinomas) on his face, back, and arms. These followed a lifetime of sun exposure due to his work in construction and roofing.

EXAMINATION
The lesion in question is located on the dorsal aspect of his mid right forearm. Measuring almost 4 cm in aggregate, the lesion is composed of 2 adjacent bright red half-moon friable nodules in a circular configuration. There is almost no erythema or edema in or around the lesion, which is neither warm nor tender to touch.

There are no palpable nodes in the adjacent epitrochlear or axillary nodal locations.

The surrounding skin of this arm, as well as that of the opposite arm, is quite thin, discolored, and scaly and is covered with stellate scars. Examination of all other sun-exposed areas reveals similar changes but no other notable lesions.

What’s the diagnosis?

DISCUSSION
It would be obvious to most readers that a biopsy is in order, given the likelihood that this lesion is either a basal cell or squamous cell carcinoma—an impression bolstered by the contextual findings of advanced sun damage and the history of skin cancer. And yet, this patient finds himself with a nonhealing friable lesion that is at least 5 years old.

Repeated misdiagnosis as infection is actually a common occurrence. One suspects that at least some of the providers making this mistake followed the patient’s lead: Many affected patients assume such lesions represent infection and therefore demand treatment appropriate for that diagnosis.

As a rule, however, bacterial infections don’t last years, especially in the absence of pain and swelling. Yes, there are nonbacterial infections (eg, those caused by acid-fast bacilli) that can be just as, if not more, indolent, but they too are apt to be painful and swollen.

Biopsy, the obvious missing step in this entire saga, would rule out any of these odd things (including melanoma, which has been known to present in this atypical morphologic manner). Other items in the differential include pyogenic granuloma and metastatic cancer (eg, breast, colon, lung).

In this case, biopsy confirmed the lesion was (as expected) a basal cell carcinoma. The lesion was excised in 2 stages over a 2.5-month period. And the patient was reminded that he will remain at extremely high risk for additional sun-caused skin cancers for the rest of his life.

TAKE-HOME LEARNING POINTS

• Nonhealing lesions should be assumed to be skin cancer until proven otherwise, especially in sun-damaged individuals.
• Correct treatment is dictated by correct diagnosis; in this case, a biopsy was clearly indicated.
• Besides the more common cancers (eg, basal cell and squamous cell carcinoma), there were numerous other items in the differential, including melanoma and even metastatic cancer.
• Only rarely do skin infections smolder for years without pain or surrounding erythema.

This 80-year-old man has been complaining to health care providers about the asymptomatic lesion on his right forearm for at least 5 years—“maybe more,” he says. During that time, he has been given a variety of diagnoses, mostly “infection” of some sort, along with prescriptions for oral antibiotics (cephalexin, trimethoprim/sulfa), topical antibiotics (mupirocin, triple-antibiotic cream), and germicidal washes (povidone and others). None of these treatment attempts has achieved results.

Prior to now, there has been no referral to dermatology, nor has any provider suggested biopsy of the lesion. The patient has a history of skin cancer (basal cell or squamous cell carcinomas) on his face, back, and arms. These followed a lifetime of sun exposure due to his work in construction and roofing.

EXAMINATION
The lesion in question is located on the dorsal aspect of his mid right forearm. Measuring almost 4 cm in aggregate, the lesion is composed of 2 adjacent bright red half-moon friable nodules in a circular configuration. There is almost no erythema or edema in or around the lesion, which is neither warm nor tender to touch.

There are no palpable nodes in the adjacent epitrochlear or axillary nodal locations.

The surrounding skin of this arm, as well as that of the opposite arm, is quite thin, discolored, and scaly and is covered with stellate scars. Examination of all other sun-exposed areas reveals similar changes but no other notable lesions.

What’s the diagnosis?

DISCUSSION
It would be obvious to most readers that a biopsy is in order, given the likelihood that this lesion is either a basal cell or squamous cell carcinoma—an impression bolstered by the contextual findings of advanced sun damage and the history of skin cancer. And yet, this patient finds himself with a nonhealing friable lesion that is at least 5 years old.

Repeated misdiagnosis as infection is actually a common occurrence. One suspects that at least some of the providers making this mistake followed the patient’s lead: Many affected patients assume such lesions represent infection and therefore demand treatment appropriate for that diagnosis.

As a rule, however, bacterial infections don’t last years, especially in the absence of pain and swelling. Yes, there are nonbacterial infections (eg, those caused by acid-fast bacilli) that can be just as, if not more, indolent, but they too are apt to be painful and swollen.

Biopsy, the obvious missing step in this entire saga, would rule out any of these odd things (including melanoma, which has been known to present in this atypical morphologic manner). Other items in the differential include pyogenic granuloma and metastatic cancer (eg, breast, colon, lung).

In this case, biopsy confirmed the lesion was (as expected) a basal cell carcinoma. The lesion was excised in 2 stages over a 2.5-month period. And the patient was reminded that he will remain at extremely high risk for additional sun-caused skin cancers for the rest of his life.

TAKE-HOME LEARNING POINTS

• Nonhealing lesions should be assumed to be skin cancer until proven otherwise, especially in sun-damaged individuals.
• Correct treatment is dictated by correct diagnosis; in this case, a biopsy was clearly indicated.
• Besides the more common cancers (eg, basal cell and squamous cell carcinoma), there were numerous other items in the differential, including melanoma and even metastatic cancer.
• Only rarely do skin infections smolder for years without pain or surrounding erythema.

This 80-year-old man has been complaining to health care providers about the asymptomatic lesion on his right forearm for at least 5 years—“maybe more,” he says. During that time, he has been given a variety of diagnoses, mostly “infection” of some sort, along with prescriptions for oral antibiotics (cephalexin, trimethoprim/sulfa), topical antibiotics (mupirocin, triple-antibiotic cream), and germicidal washes (povidone and others). None of these treatment attempts has achieved results.

Prior to now, there has been no referral to dermatology, nor has any provider suggested biopsy of the lesion. The patient has a history of skin cancer (basal cell or squamous cell carcinomas) on his face, back, and arms. These followed a lifetime of sun exposure due to his work in construction and roofing.

EXAMINATION
The lesion in question is located on the dorsal aspect of his mid right forearm. Measuring almost 4 cm in aggregate, the lesion is composed of 2 adjacent bright red half-moon friable nodules in a circular configuration. There is almost no erythema or edema in or around the lesion, which is neither warm nor tender to touch.

There are no palpable nodes in the adjacent epitrochlear or axillary nodal locations.

The surrounding skin of this arm, as well as that of the opposite arm, is quite thin, discolored, and scaly and is covered with stellate scars. Examination of all other sun-exposed areas reveals similar changes but no other notable lesions.

What’s the diagnosis?

DISCUSSION
It would be obvious to most readers that a biopsy is in order, given the likelihood that this lesion is either a basal cell or squamous cell carcinoma—an impression bolstered by the contextual findings of advanced sun damage and the history of skin cancer. And yet, this patient finds himself with a nonhealing friable lesion that is at least 5 years old.

Repeated misdiagnosis as infection is actually a common occurrence. One suspects that at least some of the providers making this mistake followed the patient’s lead: Many affected patients assume such lesions represent infection and therefore demand treatment appropriate for that diagnosis.

As a rule, however, bacterial infections don’t last years, especially in the absence of pain and swelling. Yes, there are nonbacterial infections (eg, those caused by acid-fast bacilli) that can be just as, if not more, indolent, but they too are apt to be painful and swollen.

Biopsy, the obvious missing step in this entire saga, would rule out any of these odd things (including melanoma, which has been known to present in this atypical morphologic manner). Other items in the differential include pyogenic granuloma and metastatic cancer (eg, breast, colon, lung).

In this case, biopsy confirmed the lesion was (as expected) a basal cell carcinoma. The lesion was excised in 2 stages over a 2.5-month period. And the patient was reminded that he will remain at extremely high risk for additional sun-caused skin cancers for the rest of his life.

TAKE-HOME LEARNING POINTS

• Nonhealing lesions should be assumed to be skin cancer until proven otherwise, especially in sun-damaged individuals.
• Correct treatment is dictated by correct diagnosis; in this case, a biopsy was clearly indicated.
• Besides the more common cancers (eg, basal cell and squamous cell carcinoma), there were numerous other items in the differential, including melanoma and even metastatic cancer.
• Only rarely do skin infections smolder for years without pain or surrounding erythema.

The FP suspected invasive squamous cell carcinoma (SCC) related to human papillomavirus. He recognized that the patient was at a higher risk of this secondary to the HIV/AIDS diagnosis.

The FP recommended a shave biopsy (See the Watch & Learn video on “Shave biopsy.”) of the ulcerated lesion, and the patient consented to this procedure. The FP used a surgical marker to mark an area at the edge of the ulcer including some tissue outside of the ulcer. (This is recommended for biopsy of any ulcerated skin lesion.) He then injected 1% lidocaine with epinephrine into the edge of the ulcer for anesthesia and to minimize bleeding during the shave biopsy. The shave was performed and aluminum chloride, along with electrosurgery, was used to stop the bleeding.

The pathology showed an invasive SCC. Due to the size and location of the lesions, the patient was referred to Colorectal Surgery.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Squamous cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:999-1007.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

The FP suspected invasive squamous cell carcinoma (SCC) related to human papillomavirus. He recognized that the patient was at a higher risk of this secondary to the HIV/AIDS diagnosis.

The FP recommended a shave biopsy (See the Watch & Learn video on “Shave biopsy.”) of the ulcerated lesion, and the patient consented to this procedure. The FP used a surgical marker to mark an area at the edge of the ulcer including some tissue outside of the ulcer. (This is recommended for biopsy of any ulcerated skin lesion.) He then injected 1% lidocaine with epinephrine into the edge of the ulcer for anesthesia and to minimize bleeding during the shave biopsy. The shave was performed and aluminum chloride, along with electrosurgery, was used to stop the bleeding.

The pathology showed an invasive SCC. Due to the size and location of the lesions, the patient was referred to Colorectal Surgery.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Squamous cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:999-1007.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

The FP suspected invasive squamous cell carcinoma (SCC) related to human papillomavirus. He recognized that the patient was at a higher risk of this secondary to the HIV/AIDS diagnosis.

The FP recommended a shave biopsy (See the Watch & Learn video on “Shave biopsy.”) of the ulcerated lesion, and the patient consented to this procedure. The FP used a surgical marker to mark an area at the edge of the ulcer including some tissue outside of the ulcer. (This is recommended for biopsy of any ulcerated skin lesion.) He then injected 1% lidocaine with epinephrine into the edge of the ulcer for anesthesia and to minimize bleeding during the shave biopsy. The shave was performed and aluminum chloride, along with electrosurgery, was used to stop the bleeding.

The pathology showed an invasive SCC. Due to the size and location of the lesions, the patient was referred to Colorectal Surgery.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Squamous cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:999-1007.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

The novel osteoporosis medication romosozumab received a recommendation from a Food and Drug Administration committee for approval to treat postmenopausal women at high risk of fracture.

In an 18-1 vote, the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee agreed that the risk-benefit profile of romosozumab, to be marketed by Amgen as Evenity, was favorable enough to support approval. Relative risk reductions of up to 75%, compared with placebo, and 36%, compared with alendronate, were seen in pivotal clinical trials.

A signal for increased major adverse cardiovascular events (MACE) among those receiving romosozumab had been seen in just one of the clinical trials, with a hazard ratio for MACE of 1.87 for those taking romosozumab, compared with those taking alendronate (95% confidence interval, 1.11-3.14).

Committee members were enthusiastic about the efficacy of the monoclonal antibody, which binds to sclerostin and prevents its inhibiting effect, allowing robust new bone formation. “I want to emphasize the remarkable skeletal efficacy of this drug; truly, it’s better than anything we’ve seen before,” said committee member Sundeep Khosla, MD, professor of medicine and physiology at the Mayo Clinic, Rochester, Minn.

In its application, the sponsor relied on two clinical trials. In the first, 7,180 women with osteoporosis aged 55-90 years were randomized 1:1 to receive romosozumab or placebo for 12 months in a double-blind trial. After this time, participants in each arm received follow-on treatment with denosumab (Prolia) for another 12 months. This study, dubbed Trial 337, followed morphometric vertebral fractures at 12 and 24 months. Morphometric fractures included both symptomatic and asymptomatic fractures.

Those treated with romosozumab had relative risk reductions of new vertebral fractures of 73% and 75%, compared with those given placebo at 12 and 24 months. Absolute risk reductions for vertebral fractures were 1.30% and 1.89% at 1 and 2 years (P less than .001 for both).

The second study, Trial 142, was a double-blind, active-controlled study that included 4,093 women aged 55-90 years with osteoporosis and a history of prior fragility fracture. Participants were randomized 1:1 to receive either romosozumab or alendronate for 12 months, with an additional variable period of alendronate follow-on of at least 12 months for both arms.

For Trial 142, one primary endpoint was morphometric vertebral fractures at month 24. An additional endpoint, clinical fracture, was a composite of symptomatic vertebral fractures and nonvertebral fractures. This second endpoint was assessed at the time of primary analysis, an event-driven cut point that occurred when at least 330 participants experienced a clinical fracture and all participants had completed the 24-month visit.

Bruce Jancin/Frontline Medical News

Almost all the committee’s questioning and discussion centered on this potential increased cardiovascular risk. Amgen, in discussion with the FDA, had agreed to a black box warning designed to wave off prescribing romosozumab to those at increased risk for cardiovascular disease, focusing on those with a history of MI or stroke.

Additionally, the sponsor proposed a postmarketing real-world observational study to track incidence of MACE in those receiving romosozumab, comparing them with those receiving standard of care for osteoporosis.

Several committee members pointed out a problem with the proposed safety mitigation scheme: By conducting a postmarketing observational study for a drug that has a black-box warning to exclude those at high risk for MACE, the chance of detecting an actual cardiovascular safety problem plummets. “This is the textbook example of when observational studies struggle or are virtually guaranteed to fail,” noted Tobias Gerhard, PhD, a pharmacoepidemiologist at Rutgers University, New Brunswick, N.J.

On the other hand, noted several committee members, pausing to conduct a premarketing randomized, controlled trial would keep a beneficial drug away from a population in need. A postmarketing randomized, controlled trial, even a simple trial, still presents challenges, some of the committee acknowledged. Dr. Khosla voiced the opinion that “A randomized, controlled trial is virtually impossible.”

The committee, which was charged with discussing, but not voting on, what additional data should be obtained – and when – to sort out the cardiovascular safety question, was approximately evenly divided in the matter of whether an observational or registry-based trial, or a controlled trial, would be the best path forward.

Committee member Robert A. Adler, MD, put a realistic frame around the debate. “As an endocrinologist, I deal with nuances every day. I really think the kind of clinician who is going to be using this drug is used to dealing with benefits and risks and trying to tailor treatment to a given patient,” said Dr. Adler, professor of internal medicine and epidemiology at Virginia Commonwealth University, Richmond.

In its proposed indication, Amgen defined the population of menopausal women at high risk of fracture as those with a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Romosozumab would be given as a once-monthly subcutaneous injection of 210 mg for a period of 12 months, to be followed by antiresorptive therapy.

Most of the participants in the clinical trials resided outside the United States, primarily because of the difficulty of recruiting clinical trial participants in the United States, Amgen officials said during their presentation. However, neither the time to the first positively adjudicated MACE nor bone mineral density responses at month 12 differed significantly across the various geographic regions where clinical trial sites were located, said Rachel Wagman, MD, the executive medical director of global clinical development for Amgen. Still, several committee members called for postmarketing data to focus on U.S. patients.

Romosozumab was approved for marketing in Japan on Jan. 8, 2019; approval is also being sought in Europe .

The FDA usually follows the recommendations of its advisory panels.
 

koakes@mdedge.com

The novel osteoporosis medication romosozumab received a recommendation from a Food and Drug Administration committee for approval to treat postmenopausal women at high risk of fracture.

In an 18-1 vote, the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee agreed that the risk-benefit profile of romosozumab, to be marketed by Amgen as Evenity, was favorable enough to support approval. Relative risk reductions of up to 75%, compared with placebo, and 36%, compared with alendronate, were seen in pivotal clinical trials.

A signal for increased major adverse cardiovascular events (MACE) among those receiving romosozumab had been seen in just one of the clinical trials, with a hazard ratio for MACE of 1.87 for those taking romosozumab, compared with those taking alendronate (95% confidence interval, 1.11-3.14).

Committee members were enthusiastic about the efficacy of the monoclonal antibody, which binds to sclerostin and prevents its inhibiting effect, allowing robust new bone formation. “I want to emphasize the remarkable skeletal efficacy of this drug; truly, it’s better than anything we’ve seen before,” said committee member Sundeep Khosla, MD, professor of medicine and physiology at the Mayo Clinic, Rochester, Minn.

In its application, the sponsor relied on two clinical trials. In the first, 7,180 women with osteoporosis aged 55-90 years were randomized 1:1 to receive romosozumab or placebo for 12 months in a double-blind trial. After this time, participants in each arm received follow-on treatment with denosumab (Prolia) for another 12 months. This study, dubbed Trial 337, followed morphometric vertebral fractures at 12 and 24 months. Morphometric fractures included both symptomatic and asymptomatic fractures.

Those treated with romosozumab had relative risk reductions of new vertebral fractures of 73% and 75%, compared with those given placebo at 12 and 24 months. Absolute risk reductions for vertebral fractures were 1.30% and 1.89% at 1 and 2 years (P less than .001 for both).

The second study, Trial 142, was a double-blind, active-controlled study that included 4,093 women aged 55-90 years with osteoporosis and a history of prior fragility fracture. Participants were randomized 1:1 to receive either romosozumab or alendronate for 12 months, with an additional variable period of alendronate follow-on of at least 12 months for both arms.

For Trial 142, one primary endpoint was morphometric vertebral fractures at month 24. An additional endpoint, clinical fracture, was a composite of symptomatic vertebral fractures and nonvertebral fractures. This second endpoint was assessed at the time of primary analysis, an event-driven cut point that occurred when at least 330 participants experienced a clinical fracture and all participants had completed the 24-month visit.

Bruce Jancin/Frontline Medical News

Almost all the committee’s questioning and discussion centered on this potential increased cardiovascular risk. Amgen, in discussion with the FDA, had agreed to a black box warning designed to wave off prescribing romosozumab to those at increased risk for cardiovascular disease, focusing on those with a history of MI or stroke.

Additionally, the sponsor proposed a postmarketing real-world observational study to track incidence of MACE in those receiving romosozumab, comparing them with those receiving standard of care for osteoporosis.

Several committee members pointed out a problem with the proposed safety mitigation scheme: By conducting a postmarketing observational study for a drug that has a black-box warning to exclude those at high risk for MACE, the chance of detecting an actual cardiovascular safety problem plummets. “This is the textbook example of when observational studies struggle or are virtually guaranteed to fail,” noted Tobias Gerhard, PhD, a pharmacoepidemiologist at Rutgers University, New Brunswick, N.J.

On the other hand, noted several committee members, pausing to conduct a premarketing randomized, controlled trial would keep a beneficial drug away from a population in need. A postmarketing randomized, controlled trial, even a simple trial, still presents challenges, some of the committee acknowledged. Dr. Khosla voiced the opinion that “A randomized, controlled trial is virtually impossible.”

The committee, which was charged with discussing, but not voting on, what additional data should be obtained – and when – to sort out the cardiovascular safety question, was approximately evenly divided in the matter of whether an observational or registry-based trial, or a controlled trial, would be the best path forward.

Committee member Robert A. Adler, MD, put a realistic frame around the debate. “As an endocrinologist, I deal with nuances every day. I really think the kind of clinician who is going to be using this drug is used to dealing with benefits and risks and trying to tailor treatment to a given patient,” said Dr. Adler, professor of internal medicine and epidemiology at Virginia Commonwealth University, Richmond.

In its proposed indication, Amgen defined the population of menopausal women at high risk of fracture as those with a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Romosozumab would be given as a once-monthly subcutaneous injection of 210 mg for a period of 12 months, to be followed by antiresorptive therapy.

Most of the participants in the clinical trials resided outside the United States, primarily because of the difficulty of recruiting clinical trial participants in the United States, Amgen officials said during their presentation. However, neither the time to the first positively adjudicated MACE nor bone mineral density responses at month 12 differed significantly across the various geographic regions where clinical trial sites were located, said Rachel Wagman, MD, the executive medical director of global clinical development for Amgen. Still, several committee members called for postmarketing data to focus on U.S. patients.

Romosozumab was approved for marketing in Japan on Jan. 8, 2019; approval is also being sought in Europe .

The FDA usually follows the recommendations of its advisory panels.
 

koakes@mdedge.com

The novel osteoporosis medication romosozumab received a recommendation from a Food and Drug Administration committee for approval to treat postmenopausal women at high risk of fracture.

In an 18-1 vote, the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee agreed that the risk-benefit profile of romosozumab, to be marketed by Amgen as Evenity, was favorable enough to support approval. Relative risk reductions of up to 75%, compared with placebo, and 36%, compared with alendronate, were seen in pivotal clinical trials.

A signal for increased major adverse cardiovascular events (MACE) among those receiving romosozumab had been seen in just one of the clinical trials, with a hazard ratio for MACE of 1.87 for those taking romosozumab, compared with those taking alendronate (95% confidence interval, 1.11-3.14).

Committee members were enthusiastic about the efficacy of the monoclonal antibody, which binds to sclerostin and prevents its inhibiting effect, allowing robust new bone formation. “I want to emphasize the remarkable skeletal efficacy of this drug; truly, it’s better than anything we’ve seen before,” said committee member Sundeep Khosla, MD, professor of medicine and physiology at the Mayo Clinic, Rochester, Minn.

In its application, the sponsor relied on two clinical trials. In the first, 7,180 women with osteoporosis aged 55-90 years were randomized 1:1 to receive romosozumab or placebo for 12 months in a double-blind trial. After this time, participants in each arm received follow-on treatment with denosumab (Prolia) for another 12 months. This study, dubbed Trial 337, followed morphometric vertebral fractures at 12 and 24 months. Morphometric fractures included both symptomatic and asymptomatic fractures.

Those treated with romosozumab had relative risk reductions of new vertebral fractures of 73% and 75%, compared with those given placebo at 12 and 24 months. Absolute risk reductions for vertebral fractures were 1.30% and 1.89% at 1 and 2 years (P less than .001 for both).

The second study, Trial 142, was a double-blind, active-controlled study that included 4,093 women aged 55-90 years with osteoporosis and a history of prior fragility fracture. Participants were randomized 1:1 to receive either romosozumab or alendronate for 12 months, with an additional variable period of alendronate follow-on of at least 12 months for both arms.

For Trial 142, one primary endpoint was morphometric vertebral fractures at month 24. An additional endpoint, clinical fracture, was a composite of symptomatic vertebral fractures and nonvertebral fractures. This second endpoint was assessed at the time of primary analysis, an event-driven cut point that occurred when at least 330 participants experienced a clinical fracture and all participants had completed the 24-month visit.

Bruce Jancin/Frontline Medical News

Almost all the committee’s questioning and discussion centered on this potential increased cardiovascular risk. Amgen, in discussion with the FDA, had agreed to a black box warning designed to wave off prescribing romosozumab to those at increased risk for cardiovascular disease, focusing on those with a history of MI or stroke.

Additionally, the sponsor proposed a postmarketing real-world observational study to track incidence of MACE in those receiving romosozumab, comparing them with those receiving standard of care for osteoporosis.

Several committee members pointed out a problem with the proposed safety mitigation scheme: By conducting a postmarketing observational study for a drug that has a black-box warning to exclude those at high risk for MACE, the chance of detecting an actual cardiovascular safety problem plummets. “This is the textbook example of when observational studies struggle or are virtually guaranteed to fail,” noted Tobias Gerhard, PhD, a pharmacoepidemiologist at Rutgers University, New Brunswick, N.J.

On the other hand, noted several committee members, pausing to conduct a premarketing randomized, controlled trial would keep a beneficial drug away from a population in need. A postmarketing randomized, controlled trial, even a simple trial, still presents challenges, some of the committee acknowledged. Dr. Khosla voiced the opinion that “A randomized, controlled trial is virtually impossible.”

The committee, which was charged with discussing, but not voting on, what additional data should be obtained – and when – to sort out the cardiovascular safety question, was approximately evenly divided in the matter of whether an observational or registry-based trial, or a controlled trial, would be the best path forward.

Committee member Robert A. Adler, MD, put a realistic frame around the debate. “As an endocrinologist, I deal with nuances every day. I really think the kind of clinician who is going to be using this drug is used to dealing with benefits and risks and trying to tailor treatment to a given patient,” said Dr. Adler, professor of internal medicine and epidemiology at Virginia Commonwealth University, Richmond.

In its proposed indication, Amgen defined the population of menopausal women at high risk of fracture as those with a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Romosozumab would be given as a once-monthly subcutaneous injection of 210 mg for a period of 12 months, to be followed by antiresorptive therapy.

Most of the participants in the clinical trials resided outside the United States, primarily because of the difficulty of recruiting clinical trial participants in the United States, Amgen officials said during their presentation. However, neither the time to the first positively adjudicated MACE nor bone mineral density responses at month 12 differed significantly across the various geographic regions where clinical trial sites were located, said Rachel Wagman, MD, the executive medical director of global clinical development for Amgen. Still, several committee members called for postmarketing data to focus on U.S. patients.

Romosozumab was approved for marketing in Japan on Jan. 8, 2019; approval is also being sought in Europe .

The FDA usually follows the recommendations of its advisory panels.
 

koakes@mdedge.com

More than 23% of all antibiotic prescriptions filled in 2016 were medically unnecessary, and another 36% were questionable, according to an analysis of prescribing data for 19.2 million children and nonelderly adults.

Based on the diagnosis codes for 15.5 million prescriptions filled that year, at least 3.6 million (23.2%) were “inappropriate” – prescribed for conditions for which an antibiotic is almost never recommended, such as acute upper respiratory conditions – and 5.5 million (35.5%) were “potentially inappropriate” – conditions such as acute sinusitis or otitis media, for which an antibiotic is only sometimes recommended, Kao-Ping Chua, MD, PhD, of the University of Michigan, Ann Arbor, and his associates reported in the BMJ.

Only 12.8% of filled prescriptions for the 39 oral antibiotics assessed were classified as “appropriate” under the investigators’ scheme, which assigned an antibiotic appropriateness level to all 91,738 diagnostic codes in the 2016 ICD-10-CM. Finally, 28.5% of antibiotic fills were not associated with a recent diagnosis code, suggesting that they involved phone consultations that did not result in claims or visits that were paid out of pocket and did not make it into the Truven MarketScan Commercial Claims and Encounters database used in the study, the investigators said.

The three highest levels of inappropriate fills were 70.7% in office-based settings, 6.2% in urgent care centers, and 4.7% in emergency departments.

“The unacceptable scale of inappropriate antibiotic prescribing in the United States ... underscores the need to learn more about prescriptions that aren’t justified by a diagnosis – or are written after no diagnosis at all,” coinvestigator Jeffrey Linder, MD, of Northwestern University, Chicago, said in a written statement.

Prescriptions for children, who represented almost a quarter of all antibiotic fills, were less likely to be inappropriate than those for adults aged 18-64 years. Proportions for children were 17.1% inappropriate, 48.7% potentially inappropriate, and 17.0% appropriate, compared with 25.2%, 31.4%, and 11.4%, respectively, for adults, Dr. Chua and his associates said.

“This study shows how data and analytics can help us identify and understand important challenges facing the American health care system,” said Gopal Khanna, director of the Agency for Healthcare Research and Quality, which funded the study. “We now need to use these data to spur change in the prescribing of these very common medications.”

rfranki@mdedge.com

SOURCE: Chua K-P et al. BMJ. 2019;364:k5092. doi: 10.1136/bmj.k5092.

More than 23% of all antibiotic prescriptions filled in 2016 were medically unnecessary, and another 36% were questionable, according to an analysis of prescribing data for 19.2 million children and nonelderly adults.

Based on the diagnosis codes for 15.5 million prescriptions filled that year, at least 3.6 million (23.2%) were “inappropriate” – prescribed for conditions for which an antibiotic is almost never recommended, such as acute upper respiratory conditions – and 5.5 million (35.5%) were “potentially inappropriate” – conditions such as acute sinusitis or otitis media, for which an antibiotic is only sometimes recommended, Kao-Ping Chua, MD, PhD, of the University of Michigan, Ann Arbor, and his associates reported in the BMJ.

Only 12.8% of filled prescriptions for the 39 oral antibiotics assessed were classified as “appropriate” under the investigators’ scheme, which assigned an antibiotic appropriateness level to all 91,738 diagnostic codes in the 2016 ICD-10-CM. Finally, 28.5% of antibiotic fills were not associated with a recent diagnosis code, suggesting that they involved phone consultations that did not result in claims or visits that were paid out of pocket and did not make it into the Truven MarketScan Commercial Claims and Encounters database used in the study, the investigators said.

The three highest levels of inappropriate fills were 70.7% in office-based settings, 6.2% in urgent care centers, and 4.7% in emergency departments.

“The unacceptable scale of inappropriate antibiotic prescribing in the United States ... underscores the need to learn more about prescriptions that aren’t justified by a diagnosis – or are written after no diagnosis at all,” coinvestigator Jeffrey Linder, MD, of Northwestern University, Chicago, said in a written statement.

Prescriptions for children, who represented almost a quarter of all antibiotic fills, were less likely to be inappropriate than those for adults aged 18-64 years. Proportions for children were 17.1% inappropriate, 48.7% potentially inappropriate, and 17.0% appropriate, compared with 25.2%, 31.4%, and 11.4%, respectively, for adults, Dr. Chua and his associates said.

“This study shows how data and analytics can help us identify and understand important challenges facing the American health care system,” said Gopal Khanna, director of the Agency for Healthcare Research and Quality, which funded the study. “We now need to use these data to spur change in the prescribing of these very common medications.”

rfranki@mdedge.com

SOURCE: Chua K-P et al. BMJ. 2019;364:k5092. doi: 10.1136/bmj.k5092.

More than 23% of all antibiotic prescriptions filled in 2016 were medically unnecessary, and another 36% were questionable, according to an analysis of prescribing data for 19.2 million children and nonelderly adults.

Based on the diagnosis codes for 15.5 million prescriptions filled that year, at least 3.6 million (23.2%) were “inappropriate” – prescribed for conditions for which an antibiotic is almost never recommended, such as acute upper respiratory conditions – and 5.5 million (35.5%) were “potentially inappropriate” – conditions such as acute sinusitis or otitis media, for which an antibiotic is only sometimes recommended, Kao-Ping Chua, MD, PhD, of the University of Michigan, Ann Arbor, and his associates reported in the BMJ.

Only 12.8% of filled prescriptions for the 39 oral antibiotics assessed were classified as “appropriate” under the investigators’ scheme, which assigned an antibiotic appropriateness level to all 91,738 diagnostic codes in the 2016 ICD-10-CM. Finally, 28.5% of antibiotic fills were not associated with a recent diagnosis code, suggesting that they involved phone consultations that did not result in claims or visits that were paid out of pocket and did not make it into the Truven MarketScan Commercial Claims and Encounters database used in the study, the investigators said.

The three highest levels of inappropriate fills were 70.7% in office-based settings, 6.2% in urgent care centers, and 4.7% in emergency departments.

“The unacceptable scale of inappropriate antibiotic prescribing in the United States ... underscores the need to learn more about prescriptions that aren’t justified by a diagnosis – or are written after no diagnosis at all,” coinvestigator Jeffrey Linder, MD, of Northwestern University, Chicago, said in a written statement.

Prescriptions for children, who represented almost a quarter of all antibiotic fills, were less likely to be inappropriate than those for adults aged 18-64 years. Proportions for children were 17.1% inappropriate, 48.7% potentially inappropriate, and 17.0% appropriate, compared with 25.2%, 31.4%, and 11.4%, respectively, for adults, Dr. Chua and his associates said.

“This study shows how data and analytics can help us identify and understand important challenges facing the American health care system,” said Gopal Khanna, director of the Agency for Healthcare Research and Quality, which funded the study. “We now need to use these data to spur change in the prescribing of these very common medications.”

rfranki@mdedge.com

SOURCE: Chua K-P et al. BMJ. 2019;364:k5092. doi: 10.1136/bmj.k5092.

The Food and Drug Administration has approved the first generic version of vigabatrin (Sabril) 500-mg tablets. The drug is approved for the adjunctive treatment of focal seizures in patients aged 10 years and older who have not had an adequate response to other therapies.

The approval was granted to Teva Pharmaceuticals.

An FDA announcement noted that the agency has prioritized the approval of generic versions of drugs to improve access to treatments and to lower drug costs. Vigabatrin had been included on an FDA list of off-patent, off-exclusivity branded drugs without approved generics. The approval of generic vigabatrin “demonstrates that there is an open pathway to approving products like this one,” said FDA Commissioner Scott Gottlieb, MD.

The label for vigabatrin tablets includes a boxed warning for permanent vision loss. The generic vigabatrin tablets are part of a single shared-system Risk Evaluation and Mitigation Strategy (REMS) program with other drug products containing vigabatrin.

The most common side effects associated with vigabatrin tablets include dizziness, fatigue, sleepiness, involuntary eye movement, tremor, blurred vision, memory impairment, weight gain, joint pain, upper respiratory tract infection, aggression, double vision, abnormal coordination, and a confused state. Serious side effects associated with vigabatrin tablets include permanent vision loss and risk of suicidal thoughts or actions.
 

jremaly@mdedge.com

The Food and Drug Administration has approved the first generic version of vigabatrin (Sabril) 500-mg tablets. The drug is approved for the adjunctive treatment of focal seizures in patients aged 10 years and older who have not had an adequate response to other therapies.

The approval was granted to Teva Pharmaceuticals.

An FDA announcement noted that the agency has prioritized the approval of generic versions of drugs to improve access to treatments and to lower drug costs. Vigabatrin had been included on an FDA list of off-patent, off-exclusivity branded drugs without approved generics. The approval of generic vigabatrin “demonstrates that there is an open pathway to approving products like this one,” said FDA Commissioner Scott Gottlieb, MD.

The label for vigabatrin tablets includes a boxed warning for permanent vision loss. The generic vigabatrin tablets are part of a single shared-system Risk Evaluation and Mitigation Strategy (REMS) program with other drug products containing vigabatrin.

The most common side effects associated with vigabatrin tablets include dizziness, fatigue, sleepiness, involuntary eye movement, tremor, blurred vision, memory impairment, weight gain, joint pain, upper respiratory tract infection, aggression, double vision, abnormal coordination, and a confused state. Serious side effects associated with vigabatrin tablets include permanent vision loss and risk of suicidal thoughts or actions.
 

jremaly@mdedge.com

The Food and Drug Administration has approved the first generic version of vigabatrin (Sabril) 500-mg tablets. The drug is approved for the adjunctive treatment of focal seizures in patients aged 10 years and older who have not had an adequate response to other therapies.

The approval was granted to Teva Pharmaceuticals.

An FDA announcement noted that the agency has prioritized the approval of generic versions of drugs to improve access to treatments and to lower drug costs. Vigabatrin had been included on an FDA list of off-patent, off-exclusivity branded drugs without approved generics. The approval of generic vigabatrin “demonstrates that there is an open pathway to approving products like this one,” said FDA Commissioner Scott Gottlieb, MD.

The label for vigabatrin tablets includes a boxed warning for permanent vision loss. The generic vigabatrin tablets are part of a single shared-system Risk Evaluation and Mitigation Strategy (REMS) program with other drug products containing vigabatrin.

The most common side effects associated with vigabatrin tablets include dizziness, fatigue, sleepiness, involuntary eye movement, tremor, blurred vision, memory impairment, weight gain, joint pain, upper respiratory tract infection, aggression, double vision, abnormal coordination, and a confused state. Serious side effects associated with vigabatrin tablets include permanent vision loss and risk of suicidal thoughts or actions.
 

jremaly@mdedge.com