Medication Guide App

Label Changes for:

Eligard (leuprolide acetate) injectable suspension

April 2011

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.
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