FDA Analysis Finds <em>Plan B</em> Safe For Children

FDA Analysis Finds Plan B Safe For Children

30 Jan 2012

• By Elizabeth Crawford

FDA found only 13 reports of serious pediatric AERs following ingestion of original two-dose Plan B or one-dose Plan B One-Step. In a review released Jan. 27, Office of Surveillance and Epidemiology officials said the data do not causally link the majority of pediatric AERs definitively to the drug.

FDA’s finding that reports on adverse events for Plan B formulas do not raise pediatric safety concerns supports full over-the-counter access to emergency contraceptive products containing the ingredient levonorgestrel, reproductive rights advocates say.

In a recent review of adverse event reports submitted from 2002 through 2010, FDA found only 13 reports...