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U.S. Department of Health and Human Services

Safety

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

Audience: Cardiology and endocrinology healthcare professionals

[Posted 01/21/2010] 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.

[01/21/2010 - Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia - FDA]

Previous MedWatch Alert:

[11/20/2009 - Meridia (sibutramine hydrochloride): Early Communication about an Ongoing Safety Review]