The FDA will no longer require smoking cessation pharmaceuticals like Chantix and Zyban to carry special “black box” warnings about possible psychiatric side effects, the agency announced on Friday. The decision came after a large scale trial found no increased risk of mood or behavioral side effects in patients taking these drugs compared with other cessation methods.
However, the drugs’ labels will still carry information about the risk in the their warnings sections. “The risk of these mental health side effects is still present, especially in those currently being treated for mental illnesses such as depression, anxiety disorders, or schizophrenia, or who have been treated for mental illnesses in the past. However, most people who had these side effects did not have serious consequences such as hospitalization,” the FDA said.
The agency said it will also no longer require a Patient Medication Guide detailing the risks as part of the drugs’ risk evaluation and mitigation strategy.
Labels will continue to recommend that providers observe patients taking Chantix for such symptoms, and that patients stop the drug if they occur.
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