One-third of Novel Agents Have Post-market Safety Events

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These safety events occur most frequently with biologics, psychiatric agents, and accelerated and near-regulatory deadline approvals.
These safety events occur most frequently with biologics, psychiatric agents, and accelerated and near-regulatory deadline approvals.

Nearly one-third of novel therapies have a post-market safety event, according to a study published in JAMA.1 These safety events occur most frequently with biologics, psychiatric agents, and accelerated and near-regulatory deadline approvals.

The design of most pivotal clinical trials makes it difficult to identify uncommon or long-term safety signals. This study characterized post-marketing safety events of new agents approved by the US Food and Drug Administration (FDA) between 2001 and 2010.

The cohort study evaluated 222 novel biologics (17.6%) or pharmaceuticals (82.4%). The therapeutic areas included cancer and hematology (21.2%); infectious disease (16.7%), cardiovascular, diabetes, and hyperlipidemia (11.7%); autoimmune, musculoskeletal, and dermatology (7.7%); genitourinary and renal (7.7%); psychiatry (6.8%); other (20.7%).

Priority review was granted to 34.7% and accelerated approval for 12.6%. The total median time of regulatory review was 311 days (interquartile range [IQR], 203-485 days). The majority of agents were reviewed for 200 to 399 days (40.5%).

Post-market safety events affected 71 (32%) of novel agents, which resulted in 3 withdrawals. The median time to first post-market safety event was 4.2 years (IQR, 2.5-6.0 years).

There were 61 incremental box warnings added to 43 agents. Safety communications were sent regarding 44 different agents.

Psychiatric agents were most likely to result in a safety event at 10 years (60.0%), whereas anticancer agents were least likely (21.4%; P = .006). Biologic agents were more likely to result in a post-market safety event compared with pharmaceuticals.

Post-market safety events were more likely to occur with agents that received accelerated or near-regulatory deadline approvals compared with other approval types. Priority review and orphan status were not associated with frequency of post-market safety reports.

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The authors wrote that “collaboration between the FDA and other stakeholders is necessary to develop and maintain an effective system for detecting postmarket safety events.”

Reference

  1. 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;317:1854-63. doi: 10.1001/jama.2017.5150 

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