Drugmakers debate safety of painkillers
This article contains information that could have a significant impact on many massage therapists practices. There is a legal debate currently going on regarding the safety of the relatively new class of painkillers, Cox-2 inhibitors. If these drugs are taken off the market, it's going to greatly affect our clients with arthritis or chronic pain. In addition, knowledge of the possible cardiovascular risks associated with these painkillers could prove to be of great value to the massage therapist.
By RANDOLPH E. SCHMID Associated Press Writer
WASHINGTON (AP) - The maker of Celebrex and Bextra says the two prescription painkillers are safe, even as an official of another company that makes a similar drug says he believes all drugs in the same class may pose heart or stroke problems.
Merck & Co., pulled Vioxx from the market after a long-term trial indicated that users of the popular pill could have a variety of problems from stroke to irregular heartbeat to heart attack.
Officials of Pfizer Inc. told a joint meeting of two Food and Drug Administration advisory committees on Wednesday that they believe the company's Celebrex and Bextra remain safe and effective treatments for chronic pain.
When Merck withdrew Vioxx on Sept. 30 the company acted because it feared some problem with the drug itself was leading to the strokes and heart trouble.
But Dr. Ned S. Braunstein, senior director of Merck Research Laboratories, told the panels that since then studies suggesting similar problems with Celebrex and Bextra have changed his mind.
"The data strongly suggest it is a class effect" for all drugs of that type, Braunstein said.
The drugs, designed to help people in chronic pain from conditions such as arthritis, are known as Cox-2 inhibitors. At least two other Cox-2 drugs are awaiting approval from the FDA, Arcoxia from Merck and Lumiracoxib from Novartis Pharmaceuticals. The panels planned to discuss those drugs Thursday.
The Cox-2 drugs have become blockbuster sellers over the past 15 years, offering relief from chronic pain without causing the stomach and intestinal troubles that plague many other pain killers.
The advisory committees are holding a three-day session to gather data on the safety of Cox-2 inhibitors and to make recommendations regarding their future use.
Recommendations could range from limiting these drugs to people not known to be at risk of heart problems, reducing the dose or duration of use, requiring tougher warning labels and even taking the drugs off the market.
A panel of federal judges on Wednesday assigned all pending Vioxx product liability lawsuits against Merck to U.S. District Judge Eldon E. Fallon in Louisiana. Fallon is experienced in major pharmaceutical litigation.
An FDA health official told the panels there were preliminary indications of heart problems with Vioxx before it was withdrawn, but it was difficult to sort through conflicting data.
Dr. Lourdes Villalba, medical officer responsible for Vioxx at the FDA's Center for Drug Evaluation and Research, said a study done in 2000 comparing Vioxx with the painkiller naproxen showed a higher rate of heart problems with Vioxx, but other studies had conflicting results. In discussions with Merck officials, she said, the company suggested naproxen might have a heart protective effect.
Nonetheless, in 2002 the agency required an added warning on the Vioxx label urging caution in prescribing it for people with heart conditions.
"We never bought the naproxen theory," she said.
Dr. Kenneth M. Verberg, Pfizer vice president for inflammation and immunology, defended Celebrex as safe, though he said there is little data on use of the drug for more than one year. Further long-term testing of Celebrex is needed, he said.
Merck's Braunstein said the biggest increase in heart problems occurred after 18 months of use.
Dr. Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, reminded the committees that the drugs in question are important painkillers widely used by people in chronic pain. It is important to balance the risks of drugs with their benefits, he said.
A drug that has a positive risk-benefit balance for the population as a whole, Galson added, still may cause serious problems for some individuals.
The meeting's chairman, Alistair J.J. Wood, assistant vice chancellor of Vanderbilt University Medical Center, commented that "it's worrisome when a drug that is supposed to produce a safety benefit is producing an increase in mortality."
Recommended Study
Pharmacology and Massage