FDA adds heart attack warning to Meridia label
The AP (1/22, Perrone) reports that the FDA “on Thursday added new warnings to weight loss pill Meridia [silbutramine] about the increased risk of heart attack and stroke in patients with a history of heart problems.” The new label “states only that the drug should not be used in patients with heart failure, hypertension, irregular heart beats and other problems.”
European regulators call for sibutramine ban. The Wall Street Journal (1/22, Favole) reports that the European Medicines Agency on Thursday said the sale of sibutramine should be suspended because of the risks of stroke and heart attack. The European Commission will now review the agency’s advice. The Journal also notes that both the FDA and EMA announcements come following a study of 10,000 patients that showed 11.4 percent of those who took sibutramine had a cardiovascular event, compared with 10 percent of patients who received a placebo.