Black Box Warning Added Concerning Long-Term Use of Depo-Provera Contraceptive Injection
November 17, 2004 11:33

The Food and Drug Administration (FDA) announced today that a "black box" warning, highlighting prolonged use may result in the loss of bone density, will be added to the labeling of Depo-Provera Contraceptive Injection, an established injectable drug approved for use in women to prevent pregnancy.

Why are we jsut hearing about these probelms in Depo Provera, when it has been around so long and studies were completed long ago?

Fore example, see: ClinicalTrials.gov Identifier: NCT00139685

Purpose:
To evaluate and compare Bone Mineral Density (BMD) in adolescent Depo-Provera Contraceptive Injection (DP150CI) users during depo medroxyprogesterone acetate (DMPA) therapy and following discontinuation of DMPA.

Primary Outcomes: Changes in Bone Mineral Density in adolescent Depo-Provera Contraceptive Injection (DP150CI) users will be evaluated

Study start: April 1999; Study completion: September 1999