Drug Monitoring in Children Led to Recommendations on Safety
source: http://www.bloomberg.com/apps/news?pid=20601124&sid=aMDyFr5YAcFM&refer=science
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One-third of the drugs scrutinized under a U.S. regulatory initiative to encourage testing of medicines in children needed action such as changes to prescribing information to warn of side effects, a study found.
Advisers to the Food and Drug Administration reviewed 67 medicines over four years and urged actions for 23, researchers said today in the journal Pediatrics. Among a dozen drugs for which the Pediatric Advisory Committee suggested changes to the prescribing information were Roche Holding AG's Tamiflu treatment for influenza and Johnson & Johnson's Ditropan for overactive bladders and Duragesic patches for pain.
Several side effects revealed during the advisory reviews ``were rare and life-threatening,'' according to the report. The monitoring of symptoms associated with the medicines helped identify dangers that hadn't been detected before, said Daniel K. Benjamin Jr., an author of the study and a professor of pediatrics at Duke University in Durham, North Carolina.
``Robust safety monitoring is important across all age groups, but it's obviously particularly important in children,'' Benjamin, a former pediatric consultant at the FDA, said in a telephone interview on Aug. 27. ``Clearly, this particular program should continue.''
The FDA advisers recommended that 44 of the drugs reviewed, or 66 percent, be returned to routine monitoring for side effects, according to the study.
``Fortunately, the majority of drugs given exclusivity had no adverse events of a frequency or severity that prevented a return to routine adverse event monitoring,'' the study authors wrote.
Safety monitoring soon after products come on the market ``is crucial to detect rare, serious, or pediatric-specific'' side effects, according to the study, whose authors include doctors and researchers at the FDA and Duke.
Advisers to the Food and Drug Administration reviewed 67 medicines over four years and urged actions for 23, researchers said today in the journal Pediatrics. Among a dozen drugs for which the Pediatric Advisory Committee suggested changes to the prescribing information were Roche Holding AG's Tamiflu treatment for influenza and Johnson & Johnson's Ditropan for overactive bladders and Duragesic patches for pain.
Several side effects revealed during the advisory reviews ``were rare and life-threatening,'' according to the report. The monitoring of symptoms associated with the medicines helped identify dangers that hadn't been detected before, said Daniel K. Benjamin Jr., an author of the study and a professor of pediatrics at Duke University in Durham, North Carolina.
``Robust safety monitoring is important across all age groups, but it's obviously particularly important in children,'' Benjamin, a former pediatric consultant at the FDA, said in a telephone interview on Aug. 27. ``Clearly, this particular program should continue.''
The FDA advisers recommended that 44 of the drugs reviewed, or 66 percent, be returned to routine monitoring for side effects, according to the study.
``Fortunately, the majority of drugs given exclusivity had no adverse events of a frequency or severity that prevented a return to routine adverse event monitoring,'' the study authors wrote.
Safety monitoring soon after products come on the market ``is crucial to detect rare, serious, or pediatric-specific'' side effects, according to the study, whose authors include doctors and researchers at the FDA and Duke.
