FDA panel rejects Pfizer’s arthritis drug as too dangerous

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FDA panel rejects Pfizer's arthritis drug as too risky

by Linda A. Johnson

Photo credit: CC0 Public Domain

U.S. health advisors on Thursday harshly criticized an experimental arthritis drug, saying it was too risky even if its use was restricted.

The Food and Drug Administration's panel of experts voted 19: 1 that the medication's modest benefits do not outweigh its substantial risks, even with proposed measures to restrict who receives the medicine. Pfizer is filing for FDA approval of the drug tanezumab for the treatment of pain in moderate to severe arthritis of the hip and knee. It is given by injection every two months.

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

"I am concerned about the long-term side effects," said Dr. Lee D. Katz, a radiology specialist at Yale University School of Medicine, citing the doctor's oath to "do no harm first."

The FDA is not required to follow recommendations or advice from its outside experts, but it usually does. A detailed review of the drug by FDA staff came to the same conclusion as the panel.

In a statement, Pfizer said it was disappointed with the vote on the drug, which has been in development for 15 years.

"We will continue to work with the FDA to determine the next steps," said Jim Rusnak, director of internal medicine development.

During a hearing that spanned two days, many experts found that tanezumab was no better than nonsteroidal anti-inflammatory drugs commonly used for arthritis pain, such as Aleve and Celebrex. They also raised concerns that study participants in the longest study were only followed for about a year, although people would likely take the drug for many years.

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