Label Changes for:

Meridia (sibutramine hydrochloride) capsules

March 2010

Changes have been made to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2010

CONTRAINDICATIONS

  • with a history of coronary artery disease (e.g., angina, history of myocardial infarction), congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease (stroke or transient ischemic attack (TIA))
  • with inadequately controlled hypertension > 145/90 mm Hg
  • over 65 years of age

WARNINGS

Concomitant Cardiovascular Disease
  • Due to an increased risk of heart attack and stroke in patients with cardiovascular disease, Meridia...

PRECAUTIONS 

Geriatric Use section
  • Clinical studies of sibutramine did not include sufficient numbers of patients over 65 years of age. Sibutramine is contraindicated in this group of patients
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