CHICAGO - Abbott Laboratories said Friday it would withdraw the diet drug Meridia, less than a month after it failed to win over a safety advisory panel of the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration confirmed the North Chicago-based 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 some doctors 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 health care provider about alternative weight loss and weight loss maintenance programs."
The FDA said the decision was voluntary. But many analysts believe the move came before the agency would have asked the company to remove it anyway in the face of intense criticism from consumer groups and mounting scrutiny by the Obama administration and members of Congress from both political parties on drug safety.
Last month, eight of 16 members of an FDA advisory panel said the drug should be withdrawn from the U.S. market. Meanwhile, six of the panelists said the drug should only be prescribed by "specially trained physicians" and include a strict FDA "black box" warning noting the new limits.
The other two panelists also said a new box warning should be added to alert consumers of increased risks of heart attacks and closer monitoring of patients by clinicians. None of the panelists among the Endocrinologic and Metabolic Drugs Advisory Committee said the drug should remain on the market with the labeling in its current form.
Meridia was approved by the FDA in November of 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 percent of their body weight than people on placebo who relied on diet and exercise alone."
But a growing number of doctors and scientific experts said the risks of taking Meridia far outweighed the small weight loss patients might achieve.
Meridia has not been a big seller. Revenues from the pill have 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.
The U.S. Centers for Disease Control and Prevention estimates that two in three Americans are overweight and one in three are obese, and the drug market is hungry for an effective diet pill. But the idea has been difficult to pull off.
There has not been a prescription pill for weight loss approved since 1999, when Xenical, which works by blocking the absorption of fat, was approved.
And although the FDA allowed a version of Xenical known as Alli to be sold over the counter, doctors say gastrointestinal side effects such as diarrhea have kept many consumers from taking it for long periods.
Analysts see a huge category if an effective diet drug is ever approved, especially since the obese tend to already have chronic conditions such as diabetes, high cholesterol and hypertension - conditions that generate some of the biggest categories of drug sales in the U.S.
Cholesterol drugs, for example, are the second most lucrative sales category, tallying $14.3 billion in revenue last year, according to market research for IMS Health. Antipsychotics were the top-selling class, with $14.6 billion in 2009 U.S. sales, IMS said.
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