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Abbott to withdraw Meridia in US

Abbott will withdraw obesity drug Meridia from the US following the review of a study involving the drug's cardiovascular safety in high-risk patients

Abbott will withdraw its obesity drug Meridia (sibutramine) from the US market at the request of the US Food and Drug Administration (FDA) following the federal agency's review of a long-term study of the drug's cardiovascular safety in high-risk patients.

"Abbott believes sibutramine has a positive risk/benefit profile in the approved patient population, but will comply with the FDA's request," the company said in statement.

Abbott has also agreed to withdraw the drug in Canada, and the company said it is in talks with regulators in other countries where sibutramine is marketed. Marketing of the drug has already been suspended in Europe.

The six-year study, known as SCOUT (Sibutramine Cardiovascular OUTcome Trial), enrolled approximately 10,000 patients, most of whom had underlying cardiovascular disease and so would not be eligible for Meridia under the drug's current labelling, which warns that people with pre-existing cardiovascular disease should not take the medication. The trial was a post-marketing commitment that was a condition of the drug's approval in Europe, where marketing of Meridia and other weight-loss drugs containing sibutramine was suspended in January.

The SCOUT trial showed a 16 per cent increase in the risk of major adverse cardiovascular events (non-fatal heart attacks, non-fatal strokes, resuscitation after cardiac arrest and cardiovascular death) in patients in the active drug group compared to those taking placebo. In addition, after 60 months, patients in the Meridia group had only lost a small amount of weight.

"Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke," John Jenkins, director of the FDA's Office of New Drugs in the Center for Drug Evaluation and Research, said in a statement.

However, even as the company agreed to stop selling the Meridia, Abbott argued that the bulk of the accumulated data for the drug support its safety in the appropriate patient population.

"The SCOUT results are in contrast to the vast body of sibutramine data for the on-label patient population, including 46 controlled clinical trials and more than six million patient years of use accumulated over 13 years during which the product has been available," the company said. "These data fail to confirm the excess cardiovascular risk found in the SCOUT study."

Abbott notified the FDA in November 2009 of the SCOUT study's preliminary results, and submitted label changes to the agency in January of this year contraindicating the drug in patients with underlying cardiovascular conditions.

Meridia was approved by the FDA in November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The drug was controversial from the start, and in 2002, the consumer advocacy group Public Citizen filed a petition urging the FDA to ban Meridia based on post-marketing reports of unexplained heart attacks in relatively young patients.

Following the news that Meridia would be withdrawn, Public Citizen issued a statement calling the FDA's decision "commendable, but dangerously late."

11th October 2010

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