DEPO-PROVERA (medroxyprogesterone acetate injectable suspension, USP) 3 Serious Warnings and Precautions Box

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Serious Warnings and Precautions

  • The use of DEPO-PROVERA has been associated with loss of bone mineral density (BMD) which may not be completely reversible. Loss of bone mineral density is greater with increasing duration of use.

This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if the use of DEPO-PROVERA during adolescence or early adulthood will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. A study to assess effects of DEPO-PROVERA in adolescent females showed that its use was associated with significant decline in BMD from baseline, and that 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.

  • DEPO-PROVERA should be used as indicated only if other treatments have been considered to be unsuitable or unacceptable and should be used for the shortest period of time possible. 
  • The risks and benefits of treatment should be carefully reevaluated on a regular basis in all users of this drug.
  • Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. Women should be counseled not to smoke.
  • This product does not protect against sexually transmitted infections (STIs) including HIV/AIDS. For protection against STIs it is advisable to use latex or polyurethane condoms (see 7 WARNINGS AND PRECAUTIONS).

Women considering using DEPO-PROVERA should be advised about the concerns that Depo-Provera may increase risk of HIV acquisition, about the uncertainty over whether there is a causal relationship, and about how to minimize their risk of acquiring HIV.