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Pfizer Warns of Skin, Heart Risks From Bextra
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. But so far, there's no hard evidence that Celebrex increases heart risk, says Mitch Gandelman, MD, Pfizer vice president for worldwide medical, oncology, and pain information.
"In Celebrex, we have much more data than with Bextra," Gandelman tells WebMD. "We have a slew of studies. ... We have no knowledge from those studies of any heart safety issues with Celebrex. So we have a green light to move ahead."
To date, there's no evidence that Bextra increases heart risk in arthritis patients without heart disease. But new 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. But we feel this is very specific to those patients and not indicative of the osteoarthritis or rheumatoid arthritis populations."
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.
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