After European tests found the key ingredient increased the risk of serious heart problems, Abbott Laboratories on Oct. 8 said it was pulling its obesity drug Meridia from the U.S. market. The withdrawal was being made at the request of the FDA, Abbott said.
The FDA requested the withdrawal after reviewing a cardiovascular safety study ordered by European regulators following the approval in Europe of the drug. 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% 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, said Scott Davies, a spokesman for Abbott. He described the obesity drug as "a modest product that had been expected to sell about $30 million' worth of product this year" in the United States and $100 million 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 U.S. market, the FDA warned consumers not to use weight loss pills marketed under the name Slimming Beauty Bitter Orange Slimming Capsules, which claim to be "100% 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.
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."
Copyright Agence France-Presse, 2010