Call for early postmarketing safety monitoring for pediatric trials

September 5, 2008

Safety monitoring during the early postmarketing period of pediatric trials is essential, according to a study published in the online Pediatrics.

Safety monitoring during the early postmarketing period of pediatric trials is essential, according to a study published in the online Pediatrics.

For the study, researchers reviewed Pediatric Advisory Committee meetings and data presented by the Food and Drug Administration for all drugs from June 2003 through April 2007. The treatments were divided into that were returned to routine adverse event monitoring, and those that had specific Pediatric Advisory Committee recommendations.

Forty-four (65.7%) of the drugs were returned to routine monitoring for adverse events. The Pediatric Advisory Committee recommended label changes for 12 (17.9%) drugs, continued monitoring for 10 (14.9%), production of MedGuides for 9 (13.4%), and an update on labelchanges resulting from discussions with the sponsor for 1(1.5%) drug.

The researchers stated that several of the adverse events revealed during this process were rare and life-threatening. However, most drugs given exclusivity had no adverse events of a frequency or severity that prevented a return to routine adverse event monitoring, the researchers concluded.

The full article can be found here.