The U.S. Food and Drug Administration (FDA) notified healthcare professionals today that new data indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine hydrochloride (Meridia®). Sibutramine, together with diet and exercise, is prescribed to assist in weight loss.
FDA requested that the manufacturer add a new warning and recommend that sibutramine not to be used in people with a history of cardiovascular disease. Specifically, people who have a history of the following diseases should not use sibutramine:
• Coronary artery disease (e.g., heart attack, angina)
• Stroke or transient ischemic attack (TIA)
• Heart arrhythmias (irregular beats)
• Congestive heart failure
• Peripheral arterial disease
• High blood pressure above 145/90 mmHg.
People currently using sibutramine should talk with their healthcare professional to discuss any questions they may have about their treatment, including whether they should stop taking the medication.
The risk of heart disease being worsened by Meridia came to light as part of a current study. Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) study was designed to show that weight loss with sibutramine was more effective in reducing heart disease compared to weight loss from a placebo. The people enrolled in the study were 55 years of age or older, were overweight or obese, and had a history of cardiovascular disease or type 2 diabetes plus one additional cardiovascular risk factor. Approximately 10,000 people are enrolled in the study.
In November, a report from the SCOUT study indicated that cardiovascular events occurred in 11.4% of people using sibutramine compared to 10% of people taking placebo. This difference was higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk. Further scrutiny of the data revealed that the increased risk for cardiovascular events with sibutramine occurred only in patients with a history of cardiovascular disease.
Once FDA completes its review of the full study report for SCOUT in March 2010 an open public advisory committee meeting will be convened to discuss sibutramine’s benefit/risk profile and to determine if additional regulatory actions should be taken.
According to Public Health Advocacy , overweight and obesity cost San Franciscians $437,000,000 in health care and lost productivity in 2006.