FDA adds heart attack warning to sibutramine (Meridia®) label
FDA adds heart attack warning to sibutramine (Meridia®) label
On January 21, 2010, the U.S. Food and Drug Administration (FDA) announced that it has reviewed additional data that indicate 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.
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 (i.e., 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 (i.e., >145/90 mmHg)
Patients currently using sibutramine should talk with their healthcare professional to determine if continued use of sibutramine is appropriate and discuss any questions they may have about their treatment.