Of the more than 200 drugs cleared by the FDA between 2001 and 2010, nearly one-third exhibited safety risks that were only identified after their approval, according to a new study published in JAMA.
To be clear, most of the concerns were not severe enough for a recall (only three drugs were withdrawn from the market). In the vast majority of cases, a postmarket safety event resulted in “a black box warning, or drug safety communication issued by the FDA to let physicians and patients know that new safety information has been determined,” Joseph Ross, one of the study’s authors, said in a statement.
