January 11, 2005 |
By: Laurie Edwards for Knee1
The U.S. Food and Drug Administration announced new warnings for the popular arthritis drug Bextra, manufactured by Pfizer, Inc. The drug, used as a painkiller and anti-inflammatory agent, will now carry a bolded warning about the risk of heart attacks and blood clots in patients who have just had coronary bypass surgery.
The drug will now also carry stronger warning information about the possibility of contracting a rare and serious skin condition called Stevens-Johnson syndrome.
Bextra, launched in 2001, is most commonly used to relieve the pain and inflammation from osteoarthritis, rheumatoid arthritis and menstrual pain. Like Vioxx, the hugely popular Merck & Co drug that was taken off the market this fall when studies showed it doubled the risk of heart attack and stroke in patients taking the drug for at least 18 months, Bextra is a COX-2 inhibitor.
In response to these developments, the FDA is planning a public advisory committee in February of 2005 to discuss the safety concerns of COX-2 inhibitors, including another popular Pfizer drug, Celebrex, which is also used as a painkiller.
The FDA warning comes from a study released in October by Pfizer that indicated in patients using Bextra for pain relief following heart bypass surgery, there was an increase in heart attacks, strokes and blood clots in the lungs and legs. Of the 1,500 participants, about one percent experienced at least one of these adverse side effects, while only about .5 percent of patients taking a placebo reported them.
Pfizer spokeswoman Mariann Caprino declined to comment on the new FDA warning, “There’s no new information on the label. It’s all been previously shared with the medical community,” she said.
Bextra is not approved for the treatment of pain following heart bypass surgery, and the new warning targets patients in that exact situation.
For patients using Bextra in other circumstances, such as for arthritis pain or inflammation, the drug is still considered safe and effective.
According to a statement on its Web site, “[The] FDA believes that, based on what we know now, the overall benefit of Bextra outweighs the risk when used in properly selected patients as directed in the approved labeling.”
In addition, a new “boxed” warning gives patients information about life-threatening skin reactions reported among Bextra users. As of this November, 87 reported cases and Stevens-Johnson Syndrome and other rare conditions were reported to the FDA. Four people died from the condition. Such boxed labels are intended to provide both patients and physicians with information about serious side effects of a particular drug in an effort to maximize the drug’s uses in approved settings and minimize the risk of complications.
Lethal skin reactions most often occur within two weeks of starting the drug but can manifest themselves at any point during treatment. Accordingly, doctors are urged to terminate use of the drug in patients at the first appearance of sores in the mouth, rash or other sign of allergic reaction.
For patients with a history of allergic reaction to sulfa, the new warning also indicates that Bextra contains this ingredient.
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