Abbott Laboratories 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 and European Union nations are expected to follow that recommendation.
The U.S. Food and Drug Administration has 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. The FDA also said that health care professionals should regularly monitor the blood pressure and heart rate of patients using Meridia.
Abbott has agreed to add the FDA’s contraindication language to its marketing. The drug is only approved for patients with no previous history of heart disease. As we reported previously, late last year Public Citizen had petitioned the FDA to pull Meridia off the market, based on new data about heart risks. The group’s health care specialist, Dr. Sidney Wolfe, blasted the FDA for not taking a harder line against the drug. “The FDA has once again copped out,” said Dr. Wolfe, who directs Public Citizen’s Health Research Group. The drug was prescribed to about a quarter-million patients in the U.S. last year, according to 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.
Public Citizen said 84 deaths associated with Meridia had been reported to the 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.
Source: Associated Press
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