FDA Panel To Meet in 2005 to Consider Risks of COX-2 Painkillers Related to Vioxx®
WASHINGTON, DC -- November 19, 2004 -- Criticized for not recalling the arthritis drug Vioxx® years ago, the Food and Drug Administration will meet early in 2005 to discuss the safety of similar pain medicines known as COX-2 inhibitors. Merck withdrew Vioxx® (rofecoxib) from the market in September based on reports that the drug increases the risk of heart attacks, strokes, and blood clots.
Some scientists believe that all COX-2 inhibitors, including the popular painkillers Bextra® (valdecoxib) and Celebrex® (celecoxib), can cause heart problems. Bextra® and Celebrex® have not been withdrawn from the market, however. In 2001, researchers at the Cleveland Clinic in Ohio reviewed two major studies and concluded that the data "raises a cautionary flag about the risk of cardiovascular events with COX-2 inhibitors" (JAMA 2001 Aug 22-29; 286(8): 954-9). Dr. Garret FitzGerald, a heart doctor and pharmacist, recently reported preliminary results of studies with 5,930 patients in 12 clinical trials. The number of heart attacks or strokes among the patients using Bextra® was more than twice the number among those who took placebos (NY Times, November 10, 2004, reporting on American Heart Association meeting). These were mainly patients who had undergone cardiac bypass surgery.
Will Bextra® Critic Be Banned from the Panel?
"We showed that Bextra® is no different than Vioxx®, and Pfizer [the drug's manufacturer] is trying to suppress that information," Dr. Curt Furberg, a professor of public health and co-author of the FitzGerald report commented (New York Times, November 13, 2004). According to some news reports, the FDA has barred Mr. Furberg from taking part in the panel next year. "I think they're trying to control criticism at the committee meeting," Dr. Furberg said (Seattle Times, November 13, 2004). The FDA, on the other hand, says that limiting attendance at drug advisory panels is a normal procedure. In a carefully worded press release, FDA Commissioner Dr. Lester M. Crawford now states "A decision on Dr. Furberg's participation has not been made because all of the relevant information is not yet available."
Meanwhile, the agency's handling of information about Vioxx® is being questioned this week at a Senate hearing, which was called by Sen. Charles Grassley (IA-R). Medical journal reports and Merck internal documents have suggested that both Merck and the FDA suppressed knowledge about the risks of Vioxx® and other COX-2 inhibitors. (See Vioxx® Side Effects Were Apparent and Merck Knew About Vioxx® Risks).
Vioxx®, Bextra®, and Celebrex® are nonsteroidal anti-inflammatory drugs (NSAIDs) used to treat the pain of osteoarthritis and rheumatoid arthritis. They are called COX-2 inhibitors because they block cyclooxygenase-2 (COX-2), an enzyme needed for the production of prostaglandins. Prostaglandins may cause inflammation and pain in arthritis sufferers. However, critics say that COX-2 inhibitors not only reduce inflammation, but also decrease a useful form of prostaglandin that helps keep arteries open and blood flowing (N Engl J Med. 2004 Oct 21; 351(17): 1709-11). This is what leads to heart problems.
Brayton Purcell is currently reviewing cases involving Celebrex® users who have suffered from heart attacks, blood clots, and strokes. If you or a loved one has had these conditions while taking Celebrex® please fill out a contact form to learn about your legal choices.