sibutramine hydrochloride: New contraindication to use in patients with history of CV disease

Meridia (sibutramine hydrochloride): New contraindication to use in patients with history of CV disease

Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review

Audience: Cardiology and endocrinology healthcare professionals

FDA 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 sibutramine. 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 stating 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)

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.
Read the complete MedWatch 2010 Safety summary, including a link to the FDA Follow-up Communication and the original November 2009 MedWatch alert, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198221.htm