Abbott Laboratories agreed to pull its 13-year-old diet pill Meridia off the U.S. market because of heart attack and stroke risks.
The company announced the removal today at the request of the Food and Drug Administration after Meridia was tied to 16 percent more major cardiovascular side effects in a study of 10,000 high-risk patients who were followed for as long as six years. An estimated 100,000 Americans now take Meridia and Abbott no longer promotes the drug in the U.S.
The FDA’s action comes nine months after Meridia was forced off the market in Europe because of safety concerns. Coupled with the agency’s clash with European regulators in deciding against a recall of GlaxoSmithKline Plc’s diabetes pill Avandia in September, critics say the FDA is increasingly negligent in its public-health mission.
“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 Sidney Wolfe, head of health research at the consumer group Public Citizen, in an e-mailed statement today.
Abbott said today that it would also halt sales of Meridia in Canada and in Australia, where it was marketed as Reductil. Global sales of the drug in the first nine months of this year were $80 million, including $20 million in the U.S. Abbott said it will report an expense tied to the withdrawals in the third quarter that won’t alter its quarterly or full-year forecasts.
Meridia was approved in the U.S. in 1997 even as evidence showed it can raise blood pressure and heart rate. The FDA said today that those risks were thought to be acceptable because they could be easily monitored and because weight loss seen in studies of the drug was expected to be good for the heart.
The long-term safety study, known as “Scout,” found the drug led to “only modest weight loss” of about 2.5 percent more than placebo, said John Jenkins, director of the FDA’s Office of New Drugs, on a conference call with reporters today.
The agency is reviewing whether longer studies of cardiovascular risks are needed before approving drugs intended for chronic use, particularly when patients may already be at increased risk for heart complications, Jenkins said.
Safety concerns have prompted 22 drugs to be withdrawn from the market in the past 15 years, half because of heart risks, according to FDA data obtained by Bloomberg News.
Public Citizen petitioned the FDA unsuccessfully in 2002 to ban Meridia because of reports of heart attacks in young women taking the drug. The Washington-based group submitted a second petition in December based on early results of the safety study.
Warnings Not Enough
The FDA added warnings to the drug’s prescribing information in January saying that it shouldn’t be used by people with a history of heart disease. Outside advisers to the FDA voted 8-8 on Sept. 15 when asked whether the drug should be withdrawn or remain available with new warnings or restrictions.
Abbott said today it will comply with the FDA’s request, and that it maintains Meridia has more benefits than risks.
Abbott gained 23 cents to $52.81 at 4 p.m. in New York Stock Exchange composite trading. The Abbott Park, Illinois- based maker of drugs and medical devices reported $30.8 billion in revenue last year, led by the arthritis drug Humira with $5.49 billion.
The FDA also said today that “several reports of serious side effects” have been tied to “Slimming Beauty Bitter Orange Slimming Capsules,” which contain sibutramine, Meridia’s main ingredient. The drug is sold online by Beautiful Health Inc. and samples were handed out at the 40th annual Mexican Independence Day Parade in Chicago on Sept. 12, the agency said.
Standards for New Drugs
One third of American adults are obese, raising their risk of diabetes, heart disease, and cancer. The FDA hasn’t approved a new prescription weight-loss drug since Xenical from Basel, Switzerland-based Roche Holding AG in 1999.
Withdrawing Meridia may lead to higher standards for new diet pills now under FDA review, said Diana Zuckerman, president of the National Research Center for Women & Families in Washington.
The drugs are made by Mountain View, California-based Vivus Inc., and Arena Pharmaceuticals Inc. and Orexigen Therapeutics Inc., both based in San Diego. Arena’s lorcaserin was licensed by Tokyo-based Eisai Co., and Orexigen’s Contrave is partnered with Osaka, Japan-based Takeda Pharmaceutical Co.
FDA officials must show “they’re being fair and even- handed,” she said in a telephone interview. “They should not be approving new drugs that are no more effective and no safer than Meridia.”
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