FDA reports possible link between sibutramine therapy and adverse events

The agency has reached no conclusion regarding preliminary data from the SCOUT trial.

Preliminary results from a recent trial involving sibutramine have prompted a review by the FDA, according to an early communication from the agency.

According to a statement, the agency is examining a possible association between sibutramine (Meridia, Abbott) and an elevated number of cardiac events such as MI, stroke, recurrent cardiac arrest or death that occurred in the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk for CVD (SCOUT) trial. The study compared weight loss plus sibutramine therapy with weight loss plus standard medical care in approximately 10,000 overweight/obese individuals with a history of heart disease and type 2 diabetes. Adverse CV events occurred in 11.4% of patients assigned sibutramine vs. 10% in patients assigned placebo, signaling a “higher than expected” difference, according to the statement. The agency has not yet issued conclusions regarding the study results.

“The preliminary study findings highlight the importance of avoiding the use of sibutramine in patients with a history of coronary artery disease, congestive HF, arrhythmias or stroke, as recommended in the current labeling,” the agency wrote in the early communication. “Additionally, health care professionals should continue to evaluate the benefits and risks of sibutramine, taking into account individual patient medical histories. Consumers should talk to their health care professionals about whether sibutramine is right for them.”