Product Liability

Meridia safety label warns of life-threatening cardiovascular events

The weight loss drug Meridia has updated the Contraindications, Warnings and Precautions sections of its safety label to include information about a possible link between the drug and life-threatening cardiovascular events, according to the Food and Drug Administration (FDA). The agency ordered the manufacturer of Meridia to update the label following a review on the drug that showed a higher than expected risk of cardiovascular events in patients using sibutramine (11.4 percent) compared to patients using a placebo (10 percent).

Meridia was approved by the FDA in 1997 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced calorie diet. The FDA ordered the label change based on data from several studies including the Sibutramine Cardiovascular Morbidity/Morality Outcomes in Overweight or Obese Subjects at Risk of Cardiovascular Event (SCOUT) study. The study was designed to show that weight loss with sibutramine and standard care was more effective in reducing the number of cardiovascular events compared to weight loss from a placebo and standard care. Additional data from this study showed that the increased risk for cardiovascular events with sibutramine occurred only in patients with a history of cardiovascular disease.

Meridia’s new safety label includes a contraindication in patients with a history of coronary artery disease such as angina, history of myocardial infraction; congestive heart failure; tachycardia; peripheral arterial occlusive disease; arrhythmia; or cerebrovascular disease such as stroke or transient ischemic attack. It is also contraindicated for patients with inadequately controlled hypertension and in patients older than 65 years of age. The new label also precautions against using Meridia in patients older than 65 years of age, as sibutramine is contraindicated for this age group.