CardioExchange Archive

The FDA has issued an early communication regarding a possible increased risk for adverse cardiovascular events associated with sibutramine (Meridia), a prescription drug used to manage obesity.

A postmarketing study was conducted in some 10,000 obese patients with stable heart disease or type 2 diabetes plus another risk factor. Preliminary findings show more cardiovascular events occurred in patients who took sibutramine compared with placebo (11.4% vs. 10.0%).

Pending further data analysis, the FDA recommends following current labeling instructions to avoid the drug in patients with histories of coronary artery disease, congestive heart failure, arrhythmia, or stroke. In addition, the FDA notice says, “healthcare professionals should continue to evaluate the benefits and risks of sibutramine, taking into account individual patient medical histories.”