Obesity drug carries heart risks: regulators

An appetite suppressant should be taken off the market, European regulators say.

The risks of sibutramine, marketed as Meridia in Canada, outweigh its benefits, the European Medicines Agency said Thursday, after reviewing the drug's safety.

"Doctors should no longer prescribe, and pharmacists should no longer dispense, the medicine," the agency said in a release.

"Patients currently taking sibutramine should make an appointment with their doctor at the next convenient time to discuss alternatives measures to lose weight. Patients who wish to stop treatment before seeing their doctor can do so at any time."

A six-year trial of nearly 10,000 people comparing sibutramine to a placebo showed an increased risk of serious, non-fatal cardiovascular problems such as heart attacks and strokes among those taking the drug, the regulator said.

Most people in the trial were not taking the drug in accordance with the prescribing information, the agency noted, since sibutramine is contraindicated in patients with known cardiovascular disease.

But since obese and overweight patients are likely to have a higher risk for heart attacks and strokes, the agency considered the trial data relevant to its review.

The agency's report said the suspension will remain until the company can provide data "that are sufficient to allow the identification of a group of patients for whom sibutramine’s benefits clearly outweigh its risks."

European Union nations are expected to adopt the agency's recommendation.

"We believe there are many patients who benefit from sibutramine and respectfully disagree with the committee's opinion and the recommendation to suspend the medicine," said Abbott spokesman Kurt Ebenhoch.

The U.S. Food and Drug Administration added new warning labels to Meridia warning the drugs should not be taken by patients with heart failure, hypertension, irregular heart beats and other problems.

Health Canada is conducting a review of new safety information for sibutramine, a spokesperson said. Should the review identify new safety concerns, the department said it will take appropriate action and inform health-care professionals and other Canadians as soon as possible.

In October 2007, Health Canada reminded health-care workers to review the product's guidelines before prescribing the drug, and for consumers to review the section on "when it should not be used."

Health Canada also regularly advises people not to use unapproved health products that have been found to contain undeclared sibutramine.