Abbott voluntarily pulls Meridia off market in US and Canada due to heart attack risks

Friday, October 8, 2010

Abbott withdraws diet pill in US, Canada

WASHINGTON — Abbott Laboratories said Friday it will withdraw its diet pill Meridia in the U.S. and Canada, after coming under pressure from health regulators who say the drug increases the risk of heart attack and stroke in patients with a history of heart disease.

Companies have struggled for decades to develop drugs that help people lose weight without dangerous side effects. The withdrawal of Meridia leaves just one prescription drugs on the market for long-term weight loss — Roche’s Xenical, which is not widely used. Several other generic drugs are approved for short-term weight loss, including phentermine.

Food and Drug Administration scientists said they requested the withdrawal because Meridia’s risks were not outweighed by “the very modest weight loss that people achieve on this drug.” On average, patients lost five pounds with the drug.

“Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication,” Dr. John Jenkins, the FDA’s director for new drugs, said in a statement.

Meridia is not widely used in the U.S., with a steep decline in prescriptions in recent years. About 100,000 patients use the drug in the U.S., according to the FDA. Eighty percent of users are middle-aged women.

Earlier in the day, national regulator Health Canada announced that Abbott would voluntarily pull the drug from the market there. Meridia has been available in both countries for more than a decade.

European regulators pulled the product off the market in January after a study showed that patients with heart disease had an 11 percent chance of heart attacks or stroke while taking the drug compared with a 10 percent risk for those not taking it. Heart disease is relatively common among obese patients.

Regulators in the U.S. and Canada said they based their decisions on the same data.

Weight loss drugs have long been plagued by negative side effects — particularly heart problems. In the same year Meridia was approved, Wyeth’s diet drug combination, fen-phen, was pulled off the market because of links to heart-valve damage and lung problems. In 2004, the FDA banned the weight loss supplement ephedra because of heart attack risks.

Outside medical experts repeatedly have recommended that the FDA require drugmakers to study the effect weight loss drugs have on the heart before they are released to market — as the agency requires for some other drug types. Jenkins said the agency is considering new requirements for weight loss drugs, “but we do not currently have a stated policy.”

Meridia’s withdrawal comes as the FDA reviews a new wave of weight loss drugs from several small drugmakers, but none have fared well before the FDA’s expert panels. Last month FDA experts voted against lorcaserin, a drug from Arena Pharmaceuticals, because of malignant tumors seen in animal studies. Earlier in the year, the same panel recommended against approval for Vivus Inc.’s Qnexa, after studies showed signs of heart palpitation and suicidal thoughts.

Meridia was originally approved in 1997 against the majority opinion of FDA’s panelists, who noted that increases in blood pressure were seen with the drug.

The drug later won approval in Europe, although regulators there called on Abbott to study the drug’s effect on pre-existing heart conditions.

Researchers assumed that patients taking the weight loss pill would have fewer heart problems, but the study results issued last November showed just the opposite.

Abbott, based in North Chicago, Ill., says it still believes its drug has a positive risk-benefit profile, but agreed to comply with the FDA’s request.

AP Health Writer Marley Seaman contributed from New York.

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