A study, recently published in JAMA, found significant safety events in a third of FDA-approved drugs.
Of 222 novel therapeutics (183 pharmaceuticals and 39 biologics) approved by the FDA, 32% were affected by a post-market safety event. The study found 123 new post-market safety events (three withdrawals, 61 boxed warnings and 59 FDA safety communications) during a median follow-up period of 11.7 years.
Post-market safety events of novel pharmaceuticals and biologics arise when new safety risks are identified in the marketing phase following initial regulatory approval.
The study found that rates of events were statistically significantly higher for biologics, psychiatric medicines and those receiving accelerated approval and near–regulatory deadline approval.
The authors say their findings highlight the need for continuous monitoring of the safety of novel therapeutics throughout their lifecycle, something that it is very hard to disagree with.
Downing, the primary author also noted that it may be feasible to identify post-market safety events more quickly by using data from electronic medical records and registries, administrative claims and post-market clinical trials.
To access the full paper, entitled Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010, click here.