WASHINGTON (Reuters) - European authorities urged a halt to sales of an Abbott Laboratories Inc diet pill on Thursday 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.
“The risks of these medicines are greater than their benefits,” EMEA said in a statement.
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. The FDA said it expected Abbott to submit the full Scout results in March.
An Abbott spokeswoman had no immediate comment.
Consumer group Public Citizen has asked the FDA to ban the drug, saying it is too risky.
Abbott shares were down 1.5 percent at $55.39 in afternoon New York Stock Exchange trading.
Reporting by Lisa Richwine and Ben Hirschler; Editing by Lisa Von Ahn