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FDA panel rejects Pfizer's arthritis drug as too risky

U.S. health advisers sharply criticized an experimental arthritis drug Thursday, saying that it was too risky, even with limits on its use.

The expert panel for the Food and Drug Administration voted 19-1 that the drug’s modest benefits don’t outweigh its considerable risks, even with proposed measures to restrict who gets the medicine. Pfizer is seeking FDA approval of the drug, called tanezumab, to treat pain from moderate to severe arthritis in the hips and knees. It is given by injection every two months.

In studies, a small percentage of participants saw their joint damage get worse faster, sometimes requiring hip or knee replacements. Others had swelling or nerve damage. In some, healthy joints were damaged.

“I’m concerned about the long-term side effects,” said Dr. Lee D. Katz, a radiology expert at Yale University School of Medicine, citing the physician’s oath to “first do no harm.”

The FDA is not required to follow recommendations or advice from its outside experts, but usually does.

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