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Bristol's Serzone Pulled Off Market

Antidepressant is linked to liver injury

May 20, 2004 | The Star-Ledger a href="">More information on Serzone side effects

Bristol-Myers Squibb's antidepressant drug Serzone, which has been tied to patient deaths and liver damage and, more recently, has experienced steadily declining sales, is being pulled from the market next month.

In a letter to wholesale distributors on Tuesday, Bristol-Myers said it would stop manufacturing and distributing Serzone and 16 other medicines effective June 14.

The "two main reasons" for Bristol's decision to discontinue sales of Serzone were widespread availability of generic versions of the drug and rapidly falling sales, company spokesman Robert Hutchison said.

But the history of Serzone, which went on sale in the United States in 1995, has been clouded by safety concerns. Bristol-Myers has 182 lawsuits pending against it across the country related specifically to Serzone.

As recently as Monday, another lawsuit was filed in New York City by lawyers for the family of Cassie Jo Geisenhof, a 19-year-old Minnesota woman whose death was linked to the Serzone tablets she took for depression.

Public Citizen, a nonprofit advocacy group in Washington, D.C., filed a petition with the Food and Drug Administration last year seeking a ban on Serzone. The group sued earlier this year when the FDA failed to act on its petition.

Sidney Wolfe, director of Public Citizen's Health Research Group, said Bristol-Myers didn't go far enough. The company, he said, should have ordered a recall to remove Serzone from distribution entirely.

"The failure to order a recall is irresponsible," Wolfe said. "Patients will be able to fill (or refill) prescriptions for many more months because the drug will still be available in channels of commerce, including wholesalers and retail pharmacies."

Bristol-Myers, which has its research headquarters in Lawrenceville, denied any connection between Serzone's health risks and pending litigation and its decision to pull the drug. Hutchison said the decision to discontinue sales of Serzone, as well as the 16 other medicines, was based on commercial factors.

"We will continue to vigorously defend ourselves against the Serzone litigation," Hutchison said.

Richard Evans, an analyst with Sanford C. Bernstein & Co., said product liability is one major reason a medicine gets pulled from the market. "The incremental liability exceeds the incremental profitability," Evans said.

The safety issues plaguing Serzone didn't go unnoticed by regulators.

Last year, Bristol-Myers took the drug off the market in Canada after health officials there raised concerns over 51 reports of liver injuries, including at least two patients who needed liver transplants.

In 2001, the Food and Drug Administration required the company to add a prominent warning to its packaging. The warning, referred to as a "black box," highlighted the potential risk of severe liver-related adverse effects.

The drug was banned across Europe, and bans are going into effect in Australia and New Zealand.

The drug's reputation took its toll on sales. In 2002, a year after the warning was added, sales fell 34 percent to $334 million. Then, last year, Serzone lost its patent protection, allowing generic drug makers such as Watson Pharmaceuticals to begin selling lower-priced versions of the medicine.

In its letter to wholesale distributors, Bristol-Myers said it would also stop selling a number of older medicines, including Numorphan, an injectable pain-killer; Sotacor, an older heart drug; and Quibron for asthma.

The letter was sent to 32 wholesalers and 12 warehousing chains.

Hutchison said the company's new business strategy, which includes focusing resources on specific disease areas, prompted a recent evaluation of older medicines.

"As we implement our new strategy, we're evaluating products and where we should put our resources," he said. "This is part of that evaluation."

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