Label Changes for:

Lupron Depot and Lupron Depot 3 month (leuprolide acetate) for depot suspension

October 2010

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2010

 

ADVERSE REACTIONS

Postmarketing
  • Cases of serious venous and arterial thromboembolism have been reported, including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, and transient ischemic attack. Although a temporal relationship was reported in some cases, most cases were confounded by risk factors or concomitant medication use. It is unknown if there is a casual association between the use of GnRH analogs and these events.
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