Meridia Pulled From U.S. Market Due to Heart Attack, Stroke Concerns

Meridia’s Benefits Fail to Outweigh Health Risks

November 1, 2010 — Abbott Laboratories has withdrawn its popular weight–loss drug Meridia due to an increased risk of heart attacks and strokes in those taking the drug, the Food and Drug Administration announced Friday, October 8th.

“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 a statement from John Jenkins, director of the FDA’s Office of New Drugs in the 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.”

Meridia, also known as sibutramine, was approved in November 1997 to treat obese patients—defined as those who need to lose at least 30 pounds. Meridia works by blocking the re–uptake of the brain chemicals serotonin and norepinephrine. These chemicals lead to a feeling of fullness and reduce the urge to continue eating, according to Abbott Laboratories.

SCOUT Study Demonstrated Meridia’s Limited Benefit

The FDA requested the withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT) study, which found a 16 percent increase in the risk of serious heart problems, including non–fatal heart attacks, non–fatal strokes, the need to be revived after cardiac arrest, and death.

“The patients in the European SCOUT trial did not have the same characteristics as the patients for the approved indication in the United States; however, these results, combined with other available safety data raised serious questions about Meridia’s safety for all patient groups,” said Gerald Dal Pan, director of the FDA’s Office of Surveillance and Epidemiology, in the statement.

Meridia’s Health Risks Are Not a New Finding

From the time of Meridia’s approval in 1997 through August 2003, 224 users had non–fatal heart attacks, and 54 died, including 16 heart attack victims under the age of 50 (Meridia Should Be Banned, 2005). Meridia prescribing instructions state that the medication can greatly increase blood pressure and pulse rate. Due to the limited benefits Meridia provides in comparison to the significant increase in health risks, FDA has requested that Abbott Laboratories, Meridia’s manufacturer, voluntarily withdraw the drug from the United States market. Abbott agreed to voluntary withdrawal and will stop marketing Meridia in the United States.