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Bristol-Myers Pulls Anti-Depressant In EU

Jan 8, 2003 | AP

British regulators Wednesday said Bristol-Myers Squibb Co. would voluntarily stop selling its anti-depressant Dutonin in Europe. The drug, called Serzone in the United States, has been linked to liver failure.

In a statement, the U.K. Medicines Control Board said that "as of December 2002, worldwide there have been 26 reports of liver failure. Of these, there were 10 cases involving liver transplant and 13 deaths (five in patients following liver transplant)."

For more information on Serzone side effects and your rights, click here

Bristol-Myers spokesman Rob Hutchinson confirmed that the company will stop selling the drug in the European Union countries where it's currently marketed, but said there are no plans to discontinue sales in the United States. He said the company decided to pull the drug because of low sales, not the reports of liver failure and death.

Since the drug hit the worldwide market in 1994, the drug has been prescribed to 11 million people, he said.

The company's move follows its mid-December decision to stop selling the drug in the Netherlands.

The Food and Drug Administration added a "black box" warning to the drug's U.S. label in 2001 warning of the risk of liver failure.

In 2001, the U.S. sales of the drug were $379 million, while non-U.S. sales were $30 million.

According to the FDA's Orange Book, the agency's official book of patents, Serzone will lose its market exclusivity on Sept. 16.

For more information on Serzone side effects and your rights, click here

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