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) – March 2010
- 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
Concomitant Cardiovascular Disease
- Due to an increased risk of heart attack and stroke in patients with cardiovascular disease, Meridia...
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