Since the Vioxx recall, questions have arisen about vioxx alternatives pain pills from Pfizer Inc. and Bextra, as well as non-prescription drugs such as naproxen.
The heart attack and stroke risks linked to withdrawn arthritis drug Vioxx are an inherent problem for similar pain pills, Vioxx maker Merck & Co. Inc. told advisers to the U.S. Food and Drug Administration on Wednesday.
Merck voluntarily initiated the Vioxx recall in September after a study showed the drug doubled the risk of heart attack and stroke in patients who took it for at least 18 months.
The FDA is asking two outside advisory committees if Celebrex adverse side effects and Bextra side effects are minimal enough to warrant staying on the market, if any pain relievers need stronger warnings and what further research is needed.
Studies "strongly suggest" the entire class of drugs called COX-2 inhibitors elevates the chances of cardiovascular problems, Dr. Ned Braunstein, senior director of Merck Research Laboratories, told the panel of FDA advisers. He added that older, nonprescription pain relievers called non-steroidal anti-inflammatory drugs or NSAIDs, may damage the heart, and said long-term studies were needed to determine the cardiovascular risks of those drugs. NSAIDs include ibuprofen and naproxen.
Merck is trying to win FDA approval to sell another COX-2 inhibitor called Arcoxia in the United States. A Merck spokesman had no immediate comment on why the company is still pursuing Arcoxia if the company believes all COX-2 inhibitors may harm the heart. The FDA will work quickly to act on the committee recommendations in the next few weeks, said Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research. The agency usually follows the advice from its advisory committees, but it is not legally required to do so.
Dr. Garret FitzGerald, a pharmacologist at the University of Pennsylvania, said there was evidence the COX-2 drugs caused high blood pressure and promoted blood clotting.
Simply reducing doses, as some have suggested, will not eliminate the heart disease risks because some people will react even to low doses, he said.
The panel was scheduled to hear presentations later on Wednesday from Pfizer on Celebrex and Bextra.
Conversations between Graham and his supervisor were part of the "open discussion and frank exchange about scientific and medical issues" that are part of the process for reviewing staff research presentations, the FDA said.
The company has said an analysis of 41 studies concluded that Celebrex did not appear to increase the chances of heart attacks or other serious cardiovascular problems. Pfizer recently added a warning to Bextra about heart problems in bypass patients.