Bristol-Myers to withdraw Dutonin in Europe

A Bristol-Myers Squibb spokesperson said the company will stop selling Dutonin in Europe after it was linked to 25 reports of liver failure and 18 deaths. Earlier news sources, quoting the UK's Medicines Control Agency, reported 26 cases of liver failure and 13 deaths.

Of Dutonin's $409 million global revenue, European sales account for less than 10 percent. In the US, where it is sold as Serzone, more patients use the drug than in Europe. The FDA already requires that it carry a "black box" warning on the label explaining the drug could cause rare cases of liver failure leading to transplants or death. The agency couldn't confirm the number of Serzone-related deaths in the US. It does say it continues to monitor the drug and weigh its benefits and risks.

A US consumer advocacy group said that it is planning to ask the FDA to withdraw Serzone from the US market.

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