Friday, 20 Oct 2017

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One-Third of FDA Approvals Need Post-Marketing Safety Changes

One-third of newly approved drugs in the next decade will require new safety warnings based on pharmacovigilance, according to a new study in JAMA. (Citation Source:

An analysis by the Food and Drug Administration (FDA), looked at all 222 prescription drugs (183 pharmaceuticals and 39 biologics) approved between 2001 through 2010.

They identified 71 new drugs with 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a follow-up period of 11.7 years. The overall proportion drugs affected by a postmarket safety event at 10 years was 32%.  The median time from approval to first postmarket safety event was 4.2 years.

These events resulted in either black-box warnings and lesser alerts (warnings, cautions) for many of these drugs, with only 3 being withdrawn from th market (Bextra, Raptiva, Zelnorm).

These findings were significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93), psychiatric agents, those drugs receiving accelerated approval and those with near–regulatory deadline approval. 

Post-marketing safety events were found in 32% of new drugs approved by the FDA from 2001 through 2010. Biologics, psychiatric therapeutics, and accelerated and near–regulatory deadline approval agents were at greater risk for new, evolvig safety events, suggesting an ongoing need for pharmacovigilance with new agents.



The author has no conflicts of interest to disclose related to this subject

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