Meridia Withdrawn Due to Heart Attack, Stroke RiskOct 7, 2010 | Parker Waichman LLP
The prescription diet drug Meridia is being pulled from the market in the US by Abbott Laboratories because of concerns that it may increase users’ risk for heart attacks and strokes. The US Food & Drug Administration (FDA) requested the Meridia withdrawal after determining that the modest weight loss benefit provided by the drug did not outweigh its risks. In general, patients taking Meridia lose around 4 percent more weight than those taking a placebo.
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.” At the time, clinical data indicated that more people taking Meridia lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone.
The FDA began a safety review of Meridia after a large study released last November found that people who took the drug had an 11 percent risk of cardiovascular events, while those who took a placebo had a 10 percent risk. That study, called Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT), had already prompted European regulators to remove Meridia from the market there. The study followed about 10,000 patients with a history of cardiovascular problems.
“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,” John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER), said in a statement announcing the market withdrawal.
Patients have been advised to stop taking Meridia and talk to their healthcare professional about alternative weight loss and weight loss management programs. People taking Meridia should contact a healthcare professional right away if they experience pain in the chest, heart palpitations, abnormal heart rate or rhythm, or other symptoms including dizziness and lightheadedness.
Last month, eight members of an FDA advisory committee called for Meridia to be pulled from US market. Six others on the 16-member panel favored restrictions on prescribing the weight loss drug, while the remaining two members voted to add a new black box warning to the Meridia label highlighting its association with heart attacks and strokes.
Of note, when Meridia was approved for use in the US 13 years ago, the majority opinion of the FDA’s outside advisers had opposed it because of its potential for heart problems.