Label Changes for:
Meridia (sibutramine hydrochloride) capsules
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
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.
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
- Clinical studies of sibutramine did not include sufficient numbers of patients over 65 years of age. Sibutramine is contraindicated in this group of patients.