Friday, January 22, 2010

Call to ban diet drug

The European Medicines Agency advised doctors to stop prescribing medicines containing sibutramine, which are sold under the names Reductil, Reduxade and Zelium in Europe.

WASHINGTON - EUROPEAN authorities urged a halt on Thursday to sales of a diet pill made by Abbott Laboratories Inc after concluding heart-related risks were too great.

The European Medicines Agency advised doctors to stop prescribing medicines containing sibutramine, which are sold under the names Reductil, Reduxade and Zelium in Europe and Meridia in the United States, saying: 'The risks of these medicines are greater than their benefits.'

The European Commission will consider the recommendation for suspension of marketing approval.

In the United States, the Food and Drug Administration said it had concluded the drug increased the chances of a heart attack or stroke for people with cardiovascular disease.

The FDA said Abbott had agreed to add a stronger warning that explicitly states the drug should not be used in patients with a history of cardiovascular disease.

The agency said it would hold a public advisory committee meeting to gather outside input on whether more regulatory action was needed. The meeting will take place after the agency reviews a full report from a study called Scout, which tested Meridia compared with a placebo in about 10,000 patients. -- REUTERS

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