Drug Safety, Post-FDA Approval: What to Look For

At least 1 new safety issue was detected in the years after FDA approval in 1 of every 3 novel therapeutics that received approval during a recent decade. Four therapeutic areas were affected by classwide safety communications between 2006 and 2015: triptans, phosphodiesterase-5 inhibitors, bisphosphonates, and dipeptidyl 4 peptidase inhibitors.Researchers conducted a cohort study of novel therapeutics approved between 2001 and 2010 to determine the frequency of postmarket safety events: withdrawals because of safety concerns, issuance of boxed warnings, and issuance of safety communications.They also wanted to find out whether any novel therapeutic characteristics known at the time of approval-drug class, therapeutic area, priority review, accelerated approval, orphan status, near–regulatory deadline approval, and regulatory review time-were associated with increased risk.Click on the slides above for highlights of their findings and conclusions.  Reference:Downing NS, Shah ND, Aminawung JA, et al. Postmarket safety events among novel therapeutics approved by the US Food and Drug Administration between 2001 and 2010. JAMA. 2017;317(18):1854-1863.