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.
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.