STAT+: FDA panel says risks of Pfizer pain drug outweigh the benefits

A panel of expert advisers to the Food and Drug Administration on Thursday concluded that the risks of an investigational pain treatment from Pfizer might outweigh its benefits — likely a major obstacle to the drug’s approval.

The treatment, an injectable painkiller that has been studied in osteoarthritis, has been linked to rare but serious cases of joint damage. Pfizer proposed a post-approval plan to mitigate those dangers, but in a 19-1 vote, the FDA’s assembled experts found that the company’s proposal would be insufficient to keep patients safe. 

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