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7 years ago
UPDATE 4-Abbott to stop European sales of diet drug
January 21, 2010 / 5:00 PM / 7 years ago

UPDATE 4-Abbott to stop European sales of diet drug

4 Min Read

* European agency had urged halt to sibutramine sales

* Drug to remain available outside Europe

* U.S. FDA says drug raises heart risks for some

* Abbott shares fall 1.2 pct

(Recasts with Abbott suspending European sales; updates shares)

By Lisa Richwine

WASHINGTON, Jan 21 (Reuters) - Abbott Laboratories (ABT.N) said on Thursday it will suspend European sales of a weight- loss pill in the face of a recommendation by regulators that heart-related risks made the prescription drug too dangerous.

The European Medicines Agency urged a halt to sales of drugs containing sibutramine, which are sold under the names Reductil, Reduxade and Zelium in Europe and Meridia in the United States.

"The risks of these medicines are greater than their benefits," EMEA said in its recommendation to the European Commission, adding that weight loss with the drugs is "modest" and may not last after treatment is stopped.

Abbott will comply with the recommendation even though "we respectfully disagree" and "believe there are many patients who benefit" from the drug, company spokesman Kurt Ebenhoch said.

The medicine will remain available outside of Europe, he said. Meridia's global sales were about $300 million in 2009.

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

The FDA said Abbott agreed to add a stronger warning that explicitly states the drug should not be used in patients with a history of cardiovascular disease. That includes people who have had heart attacks, strokes, irregular heart beats and uncontrolled high blood pressure.

The FDA said it would hold an advisory committee meeting to ask outside experts if 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. The FDA said it expected Abbott to submit the full Scout results in March.

Preliminary data showed 11.4 percent of patients who took Meridia died or had a heart attack, stroke or cardiac arrest compared with 10 percent for patients who took a placebo.

The FDA said its review showed the higher heart risks extended only to patients with a history of cardiovascular disease. The agency advised patients to discuss with their doctors if continued use was appropriate.

Abbott's Ebenhoch said the drug had a "positive benefit risk profile when used appropriately in the approved patient population."

Meridia is an appetite suppressant approved to treat obese adults. Its side effects range from headaches and constipation to higher blood pressure and a faster heart rate.

Obesity itself raises the risk of serious health problems such as heart attacks and diabetes.

Consumer group Public Citizen has asked the FDA to ban the drug, saying it is too risky.

Abbott shares fell 1.2 percent to close at $55.56 on the New York Stock Exchange. (Additional reporting by Ben Hirschler; editing by Lisa Von Ahn, Gary Hill and Andre Grenon)

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