The FDA has notified healthcare professionals that the review of additional data indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using Meridia (sibutramine HCl tablets, from Abbott). While the Meridia Prescribing Information already includes warnings against the use of sibutramine in patients with cardiovascular disease, the FDA has requested and the manufacturer has agreed to add a new Contraindication to the 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 (eg, heart attack, angina)
- History of stroke or transient ischemic attack
- History of heart arrhythmias
- History of congestive heart failure
- History of peripheral arterial disease
- Uncontrolled hypertension (eg, > 145/90 mmHg)
Meridia is indicated for use as an adjunct to diet in the management of obesity in patients with initial body mass index ≥30kg/m2, or ≥27kg/m2 in presence of other risk factors. Patients currently taking Meridia should talk with their healthcare provider to determine if continued use is appropriate and discuss any questions they may have about their treatment.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198221.htm.