Label Changes for:
Eligard (leuprolide acetate) injectable suspension
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2011
5 WARNINGS AND PRECAUTIONS
5.4 Cardiovascular diseases:
- Increased risk of myocardial infarction, sudden cardiac death and stroke has been reported in men ( added). Monitor for cardiovascular disease and manage according to current clinical practice.