Label Changes for:

Meridia (sibutramine hydrochloride) capsules

August 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) – August 2010

 

CONTRAINDICATIONS

Meridia is contraindicated in patients:
  • 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.
  • receiving monoamine oxidase inhibitors (MAOIs)
  • with hypersensitivity to sibutramine or any of the inactive ingredients of Meridia.
  • who have a major eating disorder (anorexia nervosa or bulimia nervosa).
  • taking other centrally acting weight loss drugs.

WARNINGS

Concomitant Cardiovascular Disease
  • Due to an increased risk of heart attack and stroke in patients with cardiovascular disease, MERIDIA should not be used in patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke

PRECAUTIONS 

Geriatric Use
  • 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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