January 21, 2010
Meridia cardiovascular safety review updateThe 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)
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198221.htm.