Pediatric postmarketing surveillance improves drug safety

NEWS IN BRIEF — Posted Sept. 22, 2008

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Food and Drug Administration rules on testing drugs in children and monitoring adverse events in this age group introduced over the past decade have translated into improved labeling and patient education materials, according to a study in the September Pediatrics.

Researchers analyzed the effect of encouraging companies to perform pediatric drug trials in exchange for a six-month extension of market exclusivity and the added surveillance activities in the year after approval of these drugs that are analyzed by the agency's Pediatric Advisory Committee.

The committee recommended label changes for 12 drugs, continued pediatric monitoring for 10 and the creation of a MedGuide for nine. Forty-four medications were returned to routine monitoring and did not require label changes.

The authors say these programs are crucial to detect adverse events specific to children.

"Just became a drug goes through testing and clinical trials does not mean its entire safety profile is known," said Danny Benjamin, MD, PhD, MPH, one of the authors and a pediatrician at Duke Children's Hospital in Durham, N.C.

Note: This item originally appeared at

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