Healthy Skepticism Library item: 50

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Publication type: news

FDA Warns Heart-Bypass Patients Shouldn't Take Painkiller Bextra
The Wall Street Journal 2004 Dec 9

Full text:

The government is warning of potential heart problems associated with the use of Pfizer Inc.‘s painkiller Bextra in people who have recently had heart-bypass surgery.

The Food and Drug Administration said Thursday it is adding the warning to the labels of Bextra, as well as strengthening the label warnings to say that there is the possibility of severe skin reactions with the drug.

Patients who recently had the bypass surgery or who are allergic to sulfa products shouldn’t take Bextra, the agency said.

In October, Pfizer informed doctors that Bextra was associated with an increase in heart attacks and stroke in heart-bypass patients.

The FDA said in a statement that it was adding heart the warning to the Bextra label because “results from a new study of more than 1,500 patients who had just had cardiac surgery show that patients treated with Bextra for pain were more likely to have heart and blood clotting problems than other patients who did not receive any drug.”

The problems included heart attack, stroke and blood clots in the legs and the lungs, the FDA said.

It said the new label will indicate Bextra isn’t indicated for treatment of pain immediately following coronary bypass graft surgery.

However, the agency said: “While all drugs have risks, 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.”

Bextra is a type of painkiller known as a cox-2 inhibitor. These drugs have become popular treatments for arthritis and other ailments.

However, Merck & Co.‘s Vioxx, another cox-2 inhibitor, was recently pulled from the market because of concerns about heart attack risk among users of the product. FDA is convening a panel in February to review all cox-2 inhibitors.