Pfizer Warns of Skin, Heart Risks From Bextra

By Daniel DeNoon, WEBMD
Updated 10/15/2004

Oct. 15, 2004 -- Bextra -- one of two U.S. approved Vioxx sister drugs -- may cause rare skin and heart side effects, its manufacturer today warned doctors.

The warning comes in the wake of Merck's voluntary withdrawal of Vioxx. That action came after a clinical trial confirmed that Vioxx increased patients' risk of heart attack and stroke.

Since then, there's been an upsurge of attention on Bextra and Celebrex. Like Vioxx, these drugs -- both made by Pfizer, a WebMD sponsor -- are in the drug class of 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 these drugs 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.

Studies of Bextra alone or in combination with parecoxib raise a red flag. Parecoxib is an injectable Cox-2 inhibitor nearly identical to Bextra. It's approved in Europe -- but not the U.S. -- for postoperative pain.

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 currently approved in the U.S. for surgery patients.

"With Bextra, we have studies going out one year -- but we don't have as much data as we do for Celebrex," Gandelman says. "Now we have data in coronary artery bypass graft studies that there is some heart risk.

Gandelman says that Bextra and Celebrex studies continue. He says the company is also considering launching new theoretical studies -- to look at ways the drugs might cause problems -- as well as practical safety studies. In addition, he says, the company will continue to change the drugs' labels to reflect new knowledge as it becomes available.

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.

What Arthritis Doctors Are Saying

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.

"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: Not everybody who took Vioxx - and not everybody who is taking Bextra or Celebrex - is going to have a problem.

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. People who are young, with no heart risks, don't necessarily have to worry if they are on Bextra or Celebrex [but] 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 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. A lot of these simple measures might be work without having to worry about drugs with more toxicity."

SOURCES: Stephen M. Lindsey, MD, head of rheumatology department, Ochsner Clinic Foundation, Baton Rouge. Pfizer news release, Oct. 15, 2004. Mitch Gandelman, MD, vice president for worldwide medical, oncology, and pain information, Pfizer, New York. Ott, E. Journal of Thoracic and Cardiovascular Surgery, June 2003; vol 125: pp 1481-1492.