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Abbott to withdraw diet drug Meridia

The FDA, which requested that the drug be pulled, cites 'clinical trial data indicating an increased risk of heart attack and stroke.'

October 08, 2010|By Bruce Japsen and Andrew Zajac

Abbott Laboratories said Friday that it would withdraw the diet drug Meridia at the request of the U.S. Food and Drug Administration, less than a month after it failed to win over one of the federal agency's safety advisory panels.

The FDA confirmed the Chicago drug giant's decision, saying Abbott withdrew the drug because of "clinical trial data indicating an increased risk of heart attack and stroke."

The withdrawal of Meridia, also known by its scientific name sibutramine, leaves just one U.S.-approved diet drug on the market: the prescription Xenical.

"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," said Dr. John Jenkins, director of the FDA's Office of New Drugs in the agency's Center for Drug Evaluation and Research. "Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their healthcare provider about alternative weight loss and weight loss maintenance programs."

Drug safety has been the subject of intense criticism from consumer groups and mounting scrutiny by the Obama administration and members of Congress from both political parties. Though Meridia remains available in 40 other countries around the world, regulatory agencies abroad have the drug under scrutiny as well.

Last month, eight of 16 members of an FDA advisory panel said Meridia should be withdrawn from the U.S. market. Six of the panelists said the drug should be prescribed only by "specially trained physicians" and should include a strict FDA black box warning noting the new limits.

The other two panelists said a new boxed warning should be added to alert consumers of increased risks of heart attacks and a need for closer monitoring of patients by clinicians. None of the members of the Endocrinologic and Metabolic Drugs Advisory Committee panel said the drug should remain on the market with the labeling in its current form.

Sidney Wolfe — head of Public Citizen, a not-for-profit health research group — criticized the FDA for waiting too long to pressure Abbott to pull the drug. Wolfe noted that in January, the European Medicines Agency recommended halting the use of Meridia based on the same evidence cited by the FDA.

"The FDA's decision to ask Abbott to withdraw the drug is commendable but dangerously too late for all of the victims of its unacceptable risks," said Wolfe, whose group asked the agency to ban Meridia in 2002.

In a statement, Abbott said it "believes [Meridia] has a positive risk/benefit profile in the approved patient population but will comply with the FDA's request."

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 FDA said. At the time, the agency said the approval "was based on clinical data showing that more people receiving sibutramine lost at least 5% of their body weight than people on placebo who relied on diet and exercise alone."

Meridia has not been a big seller. Revenue from the pill has deteriorated amid criticism of its heart risks. Abbott has said it no longer promotes the drug in the U.S., where its sales are projected this year to be $30 million.

Prescription diet pills have had trouble winning respect with consumers and doctors because of safety issues and side effects. In 1997, a diet drug combination known as fen-phen was yanked from pharmacy shelves after it was linked to heart valve damage.

Late last month, the FDA sharply limited the use of the diabetes drug Avandia because it was associated with an increased risk of heart problems. In that case, the FDA decided there was a possible benefit to patients for whom no other treatment worked, so it permitted the drug to remain on the market subject to numerous restrictions.

With Meridia, regulators thought weight loss would lead to cardiovascular benefits that would outweigh worrisome, but readily monitored, side effects such as spikes in blood pressure and heart rate. But instead, studies showed an increased risk of heart attacks and strokes.

FDA officials estimated that about 100,000 people use Meridia and said they were not aware of any risks associated with halting use of the drug.

Also on Friday, the FDA warned consumers against using Slimming Beauty Bitter Orange Slimming Capsules because they contain sibutramine — which is the active ingredient in Meridia.

bjapsen@tribune.com

azajac@tribune.com

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