European authorities urged a halt to sales of an Abbott Laboratories Inc diet pill on Thursday after concluding risks were too high, while US regulators said they had asked for a stronger warning.
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, adding weight loss with the drugs is "modest" and may not last after treatment is stopped.
The European Commission will consider the recommendation for suspension of marketing approval.
Heart attack or stroke
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. That includes people who have had heart attacks, strokes, irregular heart beats and uncontrolled high blood pressure.
An Abbott spokesperson had no immediate comment.
The FDA said it would hold an advisory committee meeting to ask outside experts if more regulatory action was needed.
History of cardiovascular disease
The meeting will take place after the agency reviews a full report from a study called Scout, which tested Reductil 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% of patients who took Meridia died or had a heart attack, stroke or cardiac arrest compared to 10% 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.
Consult your doctor
Britain's Medicines and Healthcare products Regulatory Agency mirrored EMEA's advice, urging doctors to stop prescribing the drugs. It also advised patients to discuss alternatives with their doctors, adding there was no risk to stopping the medicine beforehand.
Reductil 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. (Lisa Richwine, Reuters Health, January 2010)