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.
AdvertisementThe 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.
He described the obesity drug as "a modest product that had been expected to sell about 30 million dollars' worth of product this year" in the United States and 100 million dollars globally.
Abbott is having talks with regulatory authorities in more than 40 countries where its sibutramine-containing drug is sold, and "anticipates concluding those discussions in the coming days," Davies said.
Hours before Abbott announced it was pulling Meridia from the US market, the FDA warned consumers not to use weightloss pills marketed under the name Slimming Beauty Bitter Orange Slimming Capsules, which claim to be "100 percent herbal" but which FDA lab tests showed to contain "excessive amounts of sibutramine."
Slimming Beauty capsules are sold over the Internet and sample packets have been distributed at community events, the FDA said.
"The sample packet label is misleading because it indicates that it is a natural vitamin and calcium capsule for use in children as young as two years old," the FDA said in a statement.
The FDA said it has had "several reports of serious side effects from the use of this product including elevated blood pressure, headaches, vomiting and insomnia."