FDA to ask panel whether to ban diet drug

U.S. health regulators could pull the controversial weight-loss drug Meridia (from Abbott Laboratories) off the market over heart problems, according to documents released on Monday.

In memos released ahead of a public meeting to discuss the diet pill on Wednesday, Food and Drug Administration officials said they planned to ask outside advisers whether to ban Meridia, take other regulatory action, or leave the prescription drug as is.

While the FDA will later make the final decision, it usually follows its advisers’ advice.

Meridia, which was approved in 1997, has drawn concern for years over potential cardiovascular risks, with consumer advocates calling for its withdrawal. Critics say the slight weight loss is not worth the risk.

Use fell in late 2009, when early data showed some patients had more heart problems with Meridia than with a placebo.

On Wednesday, FDA advisers will review a company trial called Scout, which studied the drug in patients with preexisting heart disease, diabetes or both. It found patients taking Meridia had more heart attacks and strokes than those given a placebo. Those taking Meridia, or sibutramine, lost an average of 8.8 pounds (4.0 kilograms).

In separate documents also released on Monday, Abbott said all available data for Meridia “continues to support its effectiveness as a weight loss agent in an appropriate patient population.”

In January, the FDA asked Abbott to add a warning to the drug advising against its use by heart disease patients. Abbott also halted European sales of Meridia in January after regulators said heart risks made the medicine too dangerous.

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By Susan Heavey

WASHINGTON (Reuters)