13
Sep

FDA staff flags concerns about Pfizer’s quit-smoking drug study

Pfizer Inc’s (PFE.N) trial data on Chantix, a drug to help people quit smoking, failed to impress U.S. Food and Drug Administration scientists, in a blow to the company’s attempts to have a serious warning removed from the drug’s label.

The FDA staff, in a preliminary review, expressed concerns about the collection and interpretation of data from a post-marketing study on the controversial drug.

Pfizer has been trying to have the “black box” warning – which warns of psychiatric risks including suicidal thoughts, hostility and agitation – removed from the drug’s label.

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