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US FDA In ‘First Stages’ Of Reconsidering Black Box For Antipsychotics

 
• By Ramsey Baghdadi

Patient advocates and sponsors want the US to reconsider a 20-year-old class warning against the use of antipsychotics in patients with dementia. The agency is weighing the issue, but also defending the current labels of newer agents.

Sponsors want the boxed warning for antipsychotic drugs applied on a case-by-case basis rather than class-wide. (Shutterstock)
Key Takeaways
  • FDA officials are reconsidering the current class-wide warning for antipsychotic drugs, but any changes may not include newer agents.
  • Sponsors and other stakeholders want the black box warning applied on a drug-by-drug basis rather than class-wide.
  • An FDA meta-analysis found the risk of death remains similar to the 2005 meta-analysis that lead to the original warning.

The US Food and Drug Administration is in the early phases of reconsidering the long-standing class-wide “black box” warning for antipsychotics citing increased mortality in older adults with

The boxed warning, which was added to all antipsychotics’ labels in 2005, was the focus of a recent workshop co-hosted by the FDA and the Duke-Margolis Institute. The session was convened as new entrants are arriving in the antipsychotic field, including the recent approval of

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