FDA post-market evaluation results, 2013

January 30, 2014

All drugs, devices and vaccines must undergo several phases of clinical trials before they are approved and brought to market; the process of evaluating a medical product’s safety profile, however, does not stop at approval. The FDA conducts what are called post-market evaluations to determine if any unforeseen side effects occur once a drug has been used by the general population either 18 months after approval or by the time the the drug has been used by 10,000 individuals (whichever is later).

The data for several drugs were evaluated in 2013. While many passed muster with no new safety concerns, a few did not. These are the drugs that require ongoing surveillance or regulatory action, as determined by the FDA, Jan 2013-Dec 2013: