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U.S. Department of Health and Human Services

Safety

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Depo-Provera (medroxyprogesterone acetate injectable suspension)

Audience: Reproductive and other healthcare professionals

FDA and Pfizer notified healthcare professionals of the addition of a BOXED WARNING along with revisions to the WARNINGS, INDICATIONS AND USAGE, PRECAUTIONS and POSTMARKETING EXPERIENCE sections of the prescribing information to include information on the loss of significant bone mineral density. Depo-Provera Contraceptive Injection is indicated only for the prevention of pregnancy in women of child-bearing potential. Bone loss is greater with increasing duration of use and may not be completely reversible. Depo-Provera Contraceptive should be used as a long-term birth control method (eg, longer than 2 years) only if other birth control methods are inadequate.

[November 18, 2004 - Dear Healthcare Professional Letter - Pfizer]
[November 18, 2004 - Dear Healthcare Organization Leader Letter - Pfizer]
[November, 2004 - Label - Pfizer]