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Sibutramine alert

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:

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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: FDA U.S. Food and Drugs Administration
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