Label Changes for:

Depo-Provera Contraceptive injection (medroxyprogesterone acetate) injectable suspension

October 2010

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) – October 2010

 

WARNINGS AND PRECAUTIONS

Loss of Bone Mineral Density 
  • After discontinuing Depo-Provera CI in adolescents, mean BMD loss at total hip and femoral neck did not fully recover by 60 months (240 weeks) post-treatment. Similarly, in adults, there was only partial recovery of mean BMD at total hip, femoral neck and lumbar spine towards baseline by 24 months post-treatment.
Breast Cancer
  • Women who currently have or have had breast cancer should not use hormone contraceptives, including Depo-Provera CI, because breast cancer may be hormonally sensitive. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.
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