Pfizer Warns of Skin, Heart Risks From Bextra

The anti-inflammatory painkiller Bextra (search) — a drug similar to Vioxx (search) — may cause rare skin and heart side effects, its manufacturer warned doctors Friday.

The warning comes in the wake of the recent voluntary withdrawal of Vioxx by its manufacturer following a study confirming that Vioxx increased patients' risks of heart attack and stroke.

Since then, there has been an upsurge of attention on Bextra and Celebrex (search). Like Vioxx, these drugs — both made by Pfizer — are in the drug class called Cox-2 inhibitors. All these drugs are effective in relieving arthritis pain. Because they have the same mechanism of action, a lot more attention is being paid to whether Bextra and Celebrex might also increase heart risk.

Some doctors are now calling for more studies. They're worried that few clinical trials of these drugs have looked at people with existing heart disease. Many arthritis patients also suffer or are at high risk of heart disease. But so far, there's no hard evidence that Celebrex increases heart risk.

There's no evidence that Bextra increases heart risk in arthritis patients without heart disease. But studies of Bextra alone or in combination with paracoxib (search) — an injectable Cox-2 inhibitor (search) (not available in the U.S.) — raise a red flag.

Pfizer today said it is warning doctors that new data from a recently completed clinical trial — together with a study published in 2003 — show an increase in "cardiovascular events" in patients undergoing heart bypass surgery. Bextra is not approved in the U.S. for surgical patients.

"Pfizer will be conducting further studies to confirm the long-term cardiovascular safety profile of Bextra in patients who require chronic treatment for arthritis (search) with a Cox-2 specific inhibitor," Pfizer says in its news release.

Since 2002, Bextra's label has warned patients that the drug may cause rare but serious skin reactions. Now Pfizer warns that Bextra causes such reactions more often than other Cox-2 inhibitors. The risk of these skin reactions, Pfizer says, is greatest during the first two weeks of Bextra treatment. Pfizer did not return calls seeking comment before press time.

What Arthritis Doctors Are Saying About Bextra

On the front lines of the Vioxx/Cox-2 furor is Stephen M. Lindsey, MD, head of the rheumatology department at the Ochsner Clinic in Baton Rouge, La.

"My physician assistant and I are in the trenches — we're the ones answering all these phone calls," Lindsey tells WebMD.

What Lindsey is telling patients is simple: Don't get hysterical. Not everybody who took Vioxx — and not everybody who is taking Bextra or Celebrex — is going to have a problem.

"It's not like everybody is going to keel over from a heart attack," Lindsey says. "Certainly when patients get into their 60s and 70s, arthritis and heart disease run together. Those are the kind of people who, with all this information coming out, would be smart to see their doctor and make sure they are being treated properly for heart disease before taking one of these [Cox-2] drugs. But people who are young, with no heart risks, don't necessarily have to worry if they are on Bextra or Celebrex."

No single arthritis drug works for every patient. Some patients, Lindsey says, are lucky. They get relief from the first thing they try: Tylenol, perhaps, or maybe Aleve. Others run through many different medications before finding one that works. If the only thing that works for a particular patient is a Cox-2 drug, it's probably a good idea for that patient to be sure to keep his or her heart risk low.

And, Lindsey says, not everyone with arthritis needs a prescription drug.

"I always emphasize that for people with mild arthritis, there are a lot of things to try before prescription drugs," he says. "Try exercise, weight loss, Tylenol, over-the-counter supplements like glucosamine, or oils like omega-3 fatty acids (search). A lot of these simple measures might work without having to worry about drugs with more toxicity."

By Daniel J. DeNoon; reviewed by Michael W. Smith, MD

SOURCES: Stephen M. Lindsey, MD, head of rheumatology department, Ochsner Clinic Foundation, Baton Rouge, La. News release, Pfizer. Ott, E. Journal of Thoracic and Cardiovascular Surgery, June 2003; vol 125: pp 1481-1492.