Meridia will not be banned by the FDA

Weight loss drug Meridia will not be banned by the FDA - despite lobbying from a group claiming the drug had caused deaths.

Abbott Laboratories Inc. will still be able to sell its obesity drug Meridia after the U.S. Food and Drug Administration rejected a consumer group's petition to take it off the market, according to government documents released on Wednesday.

The FDA said the benefits outweighed the risks when the drug was used appropriately to treat obesity but that it would continue to monitor the drug's safety.

Between 1997 and 2003, the FDA received reports of 30 Meridia users who died of cardiovascular problems and 224 other reports of nonfatal Strokes, Heart Attacks and other cardiovascular ailments, Galson wrote.

The Public Citizen group had twice asked the FDA to pull the drug, also known as sibutramine, citing 50 deaths from cardiovascular problems. The group stood by its conviction on Wednesday that the drug should be off shelves.

MERIDIA is an effective diet pill for weight loss and the maintenance of weight loss. Meridia, along with a reduced-calorie diet, can produce significant reductions in body weight.
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While use of Meridia has declined, "many people are still getting this dangerous but not very effective drug," said Public Citizen's Health Research Group Director Sidney Wolfe. The group asked for the drug to be banned in 2002 and 2003.

Steven Galson, head of the FDA's drug division, said it was not possible to conclude Meridia caused the reported problems. He also said the agency had worked with Abbott to change the drug's labeling and to educate doctors about which patients can take the drug.

In a statement on Wednesday, Abbott criticized Public Citizen's analysis and said Meridia had repeatedly been proven safe and effective.

Meridia is an appetite suppressant approved in 81 countries to treat obese adults. It can cause side effects ranging from headaches and constipation to higher blood pressure and a faster heart rate.

Meridia is one of five approved drugs that FDA veteran scientist David Graham said should be scrutinized when he spoke at a congressional hearing last year.

On Wednesday, Graham said the FDA and the company were "relying on statistics" to keep the drug on the market. While studies show Meridia can help patients lose some pounds, the loss is not enough to improve patients' health, he said.

"What's the health benefit of losing 15 pounds if you weigh 300 pounds? There is none," Graham said. Because of the side effects, he said a study he did three years ago showed most patients stayed on the drug for less than a month.