Label Changes for:
Depo-Provera Contraceptive injection (medroxyprogesterone acetate) injectable suspension
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.
- 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.