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U.S. Department of Health and Human Services

Safety

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Zoladex (goserelin acetate) implant, 3.6 mg and Zoladex (goserelin acetate) implant, 10.8 mg

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2011

 

Summary View

 

5 WARNINGS AND PRECAUTIONS

5.3 Hyperglycemia and Diabetes
  • Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists ...
5.4 Cardiovascular Diseases
  • Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. The risk ...

17 PATIENT COUNSELING INFORMATION

17.1  Males

  • ... consideration should be given to monitoring blood glucose and/or glycosylated hemoglobin (HbA1c) periodically ...
  • A small increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice [see Warnings and Precautions (5.4)].