Drug Safety-related Labeling Changes (SrLC)

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DEPO-PROVERA (NDA-012541)

(MEDROXYPROGESTERONE ACETATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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04/03/2017 (SUPPL-86)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

17. Pediatric Use

(additions underlined)

Safety and efficacy of DEPO- PROVERA for endometrial and renal carcinoma have not been established in pediatric patients.

Studies in pre-menopausal women show that Depo-Provera is associated with loss of BMD.  It is unknown if use of Depo-Provera during adolescence and early adulthood, a critical period of bone accretion, will reduce peak bone mass. (See PRECAUTIONS: Decrease in Bone Mineral Density).

9. Decrease in Bone Mineral Density

(additions underlined)

Studies in pre-menopausal women show that medroxyprogesterone acetate given as 150 mg intramuscularly every three months reduces serum estrogen levels and is associated with loss of bone mineral density (BMD). It is unknown if use of Depo- Provera during adolescence and early adulthood, a critical period of bone accretion women, will reduce peak bone massAn evaluation of BMD may be appropriate in some patients who use higher doses of medroxyprogesterone acetate for long-term treatment of endometrial or renal carcinoma.

06/10/2016 (SUPPL-84)

Approved Drug Label (PDF)

6 Adverse Reactions

General Disorders and Administration Site Condition: (addition to this section)

  • injection site reaction, injection site pain/tenderness, injection site persistent atrophy/indentation/dimpling, lipodystrophy acquired, injection site nodule/lump. In a few instances there have been undesirable sequelae at the site of injection, such as residual lump, change in color of skin, or sterile abscess.

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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