Following a Food and Drug Administration (FDA) Safety Review first announced last November about a possible link between life-threatening cardiovascular events and the use of the weight loss drug Meridia, the agency says more studies back up the warning that the drug’s active ingredient, sibutramine hydrochloride, is dangerous to people with a history of cardiovascular disease. The agency has requested that the manufacturer add a new contraindication to the Meridia label to state that sibutramine is not to be used in patients with a history of cardiovascular disease, including
- History of coronary artery disease (such as heart attack, angina)
- History of stroke or transient ischemic attack (TIA)
- History of heart arrhythmias
- History of congestive heart failure
- History of peripheral arterial disease
- Uncontrolled hypertension
The warnings stem from the results of a Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of Cardiovascular Event (SCOUT) study, which 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. However, preliminary results showed a higher than expected risk of cardiovascular events in patients using sibutramine (11.4 percent) compared to patients using a placebo (10 percent). Additional data from the study showed that the increased risk for cardiovascular events with sibutramine occurred only in patients with a history of cardiovascular disease.
Last week, the FDA issued a warning about another popular over-the-counter weight loss medication, Alli. An FDA investigation revealed that counterfeit versions of Alli have been sold on the Internet. The active ingredient in Alli is orlistat; however, the counterfeit versions of Alli contain sibutramine instead. While the amount of sibutramine varies, in many cases the amount of sibutramine in the doses is as high as three times the usual daily dose (or twice the recommended maximum dose). The finding is of particular concern because the counterfeit drug could cause life-threatening problems in people with cardiovascular disease.
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. Patients currently using sibutramine should talk to their health care professional to determine if continued use of sibutramine is appropriate and discuss any questions they may have about their treatment.