US pharmaceutical company Abbott Laboratories on Friday said it was pulling its obesity drug Meridia from the US market after European tests found the key ingredient increased the risk of serious heart problems. The withdrawal was being made at the request of the US Food and Drug Administration (FDA), Abbott said in a statement.
The FDA requested the withdrawal after reviewing a cardiovascular safety study ordered by European regulators following the approval in Europe of the drug, both Abbott and the US drug safety watchdog said. The key ingredient, sibutramine, is a stimulant which is supposed to be available only on prescription and which could cause high blood pressure, stroke or heart attack in some consumers, the FDA said.
The European trials found a 16 percent increase in the risk of serious heart problems, including heart attack, stroke and death in patients given sibutramine compared to others given a placebo, and only a small difference in weight loss between the two groups. European regulators suspended the licence of Meridia in January this year, Scott Davies, a spokesman for Abbott, told AFP.