Bextra News

A former drug company sales executive pleaded guilty in Boston federal court to telling the roughly 100 representatives under her supervision that they should promote a pain drug for uses she knew had been rejected by the Food and Drug Administration.

Mary Holloway, who is 47 years old and lives in New Jersey, was a regional sales manager for a company listed in court documents as Pharmco. The drug she pleaded guilty to inappropriately selling carried the brand name Bextra. The painkiller has since been pulled from the market by Pfizer Inc., which had acquired its prior owner.

Pfizer Inc., the drugmaker that yesterday said it would acquire rival Wyeth for $68 billion, took a $2.3 billion charge for a record settlement of U.S. investigations into improper marketing of its Bextra painkiller and other drugs.

Pfizer reached an agreement with the U.S. Attorney in Massachusetts to "resolve previously disclosed investigations" regarding Bextra and "other open investigations," the New York-based company said yesterday in a statement. Pfizer didn't disclose details. Pfizer's fourth-quarter earnings dropped 90 percent because of the charge, the company said.

Bextra Not To Be Sold in Canada: Ruling

The painkiller Bextra will not be allowed back on the Canadian market.

Health Canada is following the advice of an expert panel that concluded Bextra should not be sold in Canada.

Yet another painkiller in the cox-2 family has been withdrawn from the market. Health Canada asked the maker of Bextra, Pfizer Canada Inc., to discontinue sales due to safety concerns, and U.S. and European regulators have done the same.

The immediate concern is that the drug can trigger an allergic reaction that causes a life-threatening skin disease. But Health Canada is continuing a more sweeping review of painkillers, and cox-2 inhibitors such as Vioxx, Celebrex and Bextra in particular, because of mounting evidence that they increase the risk of heart disease and stroke.

Health Canada asked drug maker Pfizer on Thursday to immediately discontinue sales of its arthritis drug Bextra, the same day sales were suspended in the U.S. and Europe until concerns about its safety are cleared up.

Pfizer suspended sales of the drug in the United States and the European Union following a request from the U.S. Food and Drug Administration and European regulators.

Pfizer Canada Inc. has agreed to Health Canada's request to stop sales of its painkiller Bextra until safety issues have been resolved.

The company's parent Pfizer Inc. suspended sales of Bextra in the United States and the European Union at the request of the Food and Drug Administration and European regulators. Pfizer said Thursday the FDA, in seeking the withdrawal, cited a risk of serious skin reactions to Bextra. Pfizer's Bextra sales were $1.3-billion (U.S.) last year.

A leading heart researcher says the painkiller Bextra increases the risk of heart attacks and strokes and may pose a greater risk than Vioxx. But Bextra's manufacturer calls the new findings "unsubstantiated."

In October, the painkiller Vioxx was voluntarily pulled from the market because it was found to increase heart attack and stroke risk.

Bextra, a Pfizer pain drug that received a sales boost when Merck's Vioxx was pulled from the market, will probably be tagged with the most prominent type of safety warning used by the Food and Drug Administration.

According to Pfizer, Bextra can cause a rare but sometimes life-threatening drug reaction called Stevens-Johnson Syndrome in which the skin, mouth, and eyes can become horribly blistered. Other drugs, including Pfizer's arthritis pill Celebrex, can also cause this condition—but it seems to be more common with Bextra than other medications. Patients taking Bextra who develop the condition tend to get it in the first two weeks of treatment.

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