By Catherine Larkin
(Adds potential effect on new drugs in 11th paragraph.)
Oct. 8 (Bloomberg) -- 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 a study linked Meridia to 16 percent more major cardiovascular side effects among 10,000 high-risk patients who were followed for as long as six years. Abbott had said U.S. sales would be $30 million this year.
The drug was withdrawn in Europe in January while the FDA waited to review more data from the study and sought outside input on a decision. Coupled with the FDA’s clash with European regulators in deciding against a recall of GlaxoSmithKline Plc’s diabetes pill Avandia in September, critics say the U.S. agency is increasingly negligent in its public-health mission.
“Consumers are being harmed by drugs that shouldn’t be on the market,” said Sidney Wolfe, head of health research at the Washington-based consumer group Public Citizen, in a telephone interview before today’s decision. “Why do you have to go sacrificing more people in order to have definitive proof that this drug shouldn’t be around?”
Abbott also said earlier today that it would stop sales of Meridia in Canada and in Australia, where it was marketed as Reductil.
Heart Concerns
Meridia was approved in the U.S. in 1997 even as evidence showed it can raise blood pressure and heart rate. Public Citizen petitioned the FDA unsuccessfully in 2002 to ban the diet pill 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 long-term safety study.
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 Outside advisers to the FDA voted 8-8 on Sept. 15 when asked whether the drug should be withdrawn or remain available with new warnings or restrictions.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 22 cents to $52.80 at 12:09 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.
‘Serious Side Effects’
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 Chicago on Sept. 12, the agency said.
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.”
Safety concerns have now 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.
--Editors: Andrew Pollack, Steve Walsh
To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.
Friday, October 08, 2010
Abbott Pulls Meridia in U.S. Amid FDA Safety Concerns - BusinessWeek
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3 comments:
Certain medications carry risks, and monthly tests are required before refills are given (e.g. clozaril). Morbid obesity carries multiple risks, including death from cardiovascular events. Can't FDA stipulate conditions that refills be given only after patients are seen and have had appropriate checks, such as blood pressure and whatever else might be deemed necessary to maintain safety?
Sources are indicating that Pfizer is set to purchase Arena Pharmaceuticals. This can really boast both companies especially Arena as they try to get thier obesity drug approved
I started taking Meridia about 2-3 weeks ago and haven't lost a pound. In fact, it actually has been doing the opposite of what it is supposed to do. It doesn't really control my appetite and actually makes me crave lots of sweets.
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