updated 1/21/2010 1:23:05 PM ET 2010-01-21T18:23:05

Federal health regulators on Thursday added new warnings to weight loss pill Meridia about the increased risk of heart attack and stroke in patients with a history of heart problems.

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The Food and Drug Administration's labeling announcement came on the same day the European Medicines Agency advised doctors and pharmacists to stop using the drug. The agency said "the risks of these medicines are greater than their benefits," and recommended that Meridia's marketing license be suspended.

The group's recommendation must be adopted by the European Commission to take effect.

The FDA's new label states only that the drug should not be used in patients with heart failure, hypertension, irregular heart beats and other problems.

In a statement posted online, the FDA urged patients to talk to their doctors about whether they should continue taking the drug.

"Health care professionals should regularly monitor the blood pressure and heart rate of patients using," Meridia, the FDA stated.

Meridia is marketed by Abbott Laboratories, which agreed to add the FDA's contraindication language. The company, based in North Chiacgo, previously stressed that the drug is only approved for patients with no previous history of heart disease.

Consumer advocacy group Public Citizen petitioned the FDA to pull Meridia off the market late last year, based on new data about heart risks.

The group's health care specialist, Dr. Sidney Wolfe, blasted the FDA on Thursday for not taking a harder line against the drug.

"The FDA has once again copped out," said Wolfe, who directs the group's Health Research Group

Public Citizen reported there had been a total of 84 deaths associated with Meridia reported to FDA as of June last year. Regulators previously rejected a 2002 petition from Public Citizen to withdraw Meridia, saying they wanted to wait for the findings of a 10,000-patient study.

Preliminary findings from that study released in November showed a slightly higher risk of heart-related problems in patients taking Meridia, also called sibutramine, compared with a dummy pill. Patients in the study were older than 55 and overweight with a history of heart disease or diabetes.

The drug was prescribed to about quarter million patients in the U.S. last year, according Public Citizen.

FDA approved Meridia in 1997 as a weight loss aid alongside diet and exercise. The drug is related to the amphetamine family of stimulants.

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