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
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
- ... 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)].