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.
“One of the basic principles of medicine is first do no harm,” said Lee Katz, a professor of radiology at the Yale School of Medicine, explaining his vote against Pfizer’s plan. “I’m concerned about the long-term side effects of the sponsor’s drug.”