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Litigation

Abbott Withdraws Diet Drug Meridia From U.S. Market

ABBOTT PARK, Ill. - (Mealey's) After an unfavorable assessment by a Food and Drug Administration expert committee regarding cardiovascular risk, Abbott Laboratories on Oct. 8 agreed with an FDA request to withdraw the weight-loss drug Meridia (sibutramine) from the U.S. market.

The FDA said it requested withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT).  SCOUT, which followed approximately 10,000 patients for six years at the behest of European regulatory authorities, showed a 16 percent increase in the risk of serious heart events, the FDA said, including nonfatal heart attack, nonfatal stroke, the need to be resuscitated once the heart stopped and death, in a group of patients given sibutramine compared with another group given placebo.  The weight-loss difference between placebo and sibutramine was "small," the FDA said.

"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 John Jenkins, M.D., director of the Office of New Drugs in the FDA'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 approved Meridia in November 1997 for weight loss and maintenance of weight loss in obese people and certain overweight people with other risks for heart disease.  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, the FDA said.

The FDA's Endocrinologic and Metabolic Drugs Committee on Sept. 15 failed to reach a consensus on the future of Meridia, except to agree that the marketing status quo should not be extended.  The eight members who voted to keep Meridia on the market agreed that Abbott should be required to issue a black-box warning -- the strongest available to the FDA.  Six members also said Meridia should be prescribed only by specialists.  Meridia has been withdrawn by European regulators.

Patients should discontinue use of sibutramine and consult their physician for alternatives, the FDA said.  Patients can call Abbott's medical information line in the United States at 1-866-257-8909 or visit www.sibutramine.com.

Consolidated federal litigation over Meridia came to an end in May 2006 when the Sixth Circuit U.S. Court of Appeals affirmed the multidistrict litigation court's summary judgment ruling (Meridia Products Liability Litigation, Steering Committee, et al. v. Abbott Laboratories, et al., No. 04-4175, 6th Cir.).

Plaintiffs began filing complaints against Abbott in 2002, alleging that Meridia caused heart attacks, strokes, tachycardia, palpitations, chest pain, high blood pressure and death.  About 100 federal cases were consolidated into an MDL and transferred to the U.S. District Court for the Northern District of Ohio.

In July 2004, Judge James A. Gwinn granted in part Abbott's motion to exclude the testimony of plaintiff expert Arnold Schwartz, Ph.D., but granted Abbott's motion for summary judgment, dismissing all of the plaintiffs' claims against the pharmaceutical defendants.

[Editor's Note:  Full coverage will be in the Oct. 21 issue of Mealey's Emerging Drugs & Devices.  In the meantime, the FDA memorandum is available at www.mealeysonline.com or by calling the Customer Support Department at 1-800-833-9844.  Document #87-101013-008X.  For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]

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For more information, call editor Tom Moylan at 610-205-1120, or e-mail him at tom.moylan@lexisnexis.com.