FDA Panel Supports Continued Testing Of Pain Drugs
A panel of arthritis experts recommended Monday that the federal government allow continued testing of an experimental class of pain drugs for arthritis, despite links to bone decay and joint failure.
The Food and Drug Administration's 21-member panel of arthritis experts voted unanimously that research on the nerve-blocking drugs should continue, with certain safety precautions. Reports of joint failure led the agency to halt studies of the drugs in 2010 before any of the medications could be submitted for U.S. approval.
Pfizer Inc., Johnson & Johnson and Regeneron Pharmaceuticals have asked the FDA to lift the moratorium on testing of their drugs. The FDA will weigh the advice of its panel before making a final decision.
"There's clearly a worrisome safety signal, but in spite of that, I think there's an unmet need in certain patient populations," said panelist Dr. Sherine Gabriel, of the Mayo Medical School in Rochester, Minn.
Panelists noted that not all patients respond to medications currently on the market, like Aleve and aspirin. The experts also said that the drugs could prove useful in treating a variety of other chronic pain conditions for which there are few options.
"Anything that has the hope of helping pain patients is worth pursuing," said Susan Broyles, the patient representative on the panel.