FDA says weight loss pill increases heart attack risks in patients with history of disease

FDA adds heart attack warning to Meridia diet pill

WASHINGTON — Abbott Laboratories on Thursday stopped marketing a weight loss pill in Europe after regulators there said the drug increases the risk of heart attack and stroke when used by heart disease patients.

The European Medicines Agency advised doctors and pharmacists to stop using sibutramine, saying “the risks of these medicines are greater than their benefits.” The agency said Abbott’s license to market the drug should be suspended, a recommendation European Union nations are expected to adopt.

“We believe there are many patients who benefit from sibutramine and respectfully disagree with the committee’s opinion and the recommendation to suspend the medicine,” said Abbott spokesman Kurt Ebenhoch.

Meanwhile, the U.S. Food and Drug Administration added new warnings to sibutramine, marketed here as Meridia, highlighting its increased risks for patients with a history of heart problems. The new label says the drug should not be taken by 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.

Abbott agreed to add the FDA’s contraindication language to its marketing. The company, based in North Chicago, 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 said 84 deaths associated with Meridia had been reported to FDA as of June. 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, compared with a dummy pill. Patients in the study were older than 55 and overweight with a history of heart disease or diabetes.

Abbott spokesman Ebenhoch said 90 percent of patients in the study had “underlying cardiovascular disease and would not be eligible to receive sibutramine under the current prescribing information.”

The drug was prescribed to about a 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.

Shares of Abbott Laboratories fell 68 cents, or 1.2 percent, to close at $55.56 Thursday.