The U.S. Food and Drug Administration (FDA) has reviewed data that indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine, marketed as the weight loss medication Meridia.
The sibutramine drug label already includes warnings against the use of sibutramine in patients with cardiovascular disease. However, based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label.
According to the consumer advocacy group Public Citizen, at least 84 deaths have been associated with the drug have been reported to the FDA.
The contraindication will state that sibutramine is not to be used in patients with a history of cardiovascular disease, including:.
* History of coronary artery disease (e.g., 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 (e.g., > 145/90 mmHg)