The FDA is warning doctors that weight loss pill Meridia may increase the risk of heart attack and stroke in patients with a history of heart problems.
The FDAis adding new labeling to the drug, stressing that it should not be used in patients with heart failure, hypertension, irregular heart beats and other problems.
Meridia was introduced into the market in 1997 as a weight loss pill. It's Sibutramine, and can be found as sibutramine hydrochloride monohydrate.
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.