Recalls

Study suggests link between weight-loss drug and life-threatening cardiovascular events

The Food and Drug Administration (FDA) has notified cardiology and endocrinology healthcare professionals of an ongoing safety review on a possible link between a popular weight loss medication and an increased risk of life-threatening cardiovascular events. The medication in question is sibutramine hydrochloride, marketed as Meridia and sold by prescription only in the United States. 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.

According to the early communication, patients using Meridia have a higher number of cardiovascular events such as heart attack, stroke, resuscitated cardiac arrest, or death than patients using a placebo. Meridia is only recommended for obese patients with an initial body mass index (BMI) of equal to or more than 30 kg/m2, or BMI of equal to or more than 27 kg/m2 with other risk factors such as diabetes, high cholesterol or controlled high blood pressure.

The study, named the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of Cardiovascular Event (SCOUT), began in 2002. 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. The study included approximately 10,0000 patients who were 55 years of age or older, overweight or obese, and had a history of heart disease or type 2 diabetes plus one additional cardiovascular risk factor. Patients who recently had a heart attack or stroke, or had poorly controlled congestive heart failure were not included in the study. The preliminary analysis shows that cardiovascular events were reported in 11.4 percent of patients using sibutramine compared to 10 percent of patients using a placebo, a difference that researchers say is higher than expected.

The FDA says it is conducting an ongoing analysis of the data and is making no conclusions about the preliminary findings at this time. What it does state in the early communication is that the findings highlight the importance of avoiding the use of sibutramine in patients with a history of coronary artery disease (heart disease), congestive heart failure (CHF), arrhythmias, or stroke, as is currently recommended in the sibutramine labeling.