|August 2011 · Vol. 23, No. 8
AN APPEAL TO THE FDA
Remove the black-box warning
for depot medroxyprogesterone acetate!
Guidance about DMPA in the black box isn’t evidence-based, and the warning deprives women of long-term use of this safe and effective contraceptive
Dr. Kaunitz is Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville. He serves on the OBG Management Board of Editors.
Dr. Grimes is Clinical Professor, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, and a Distinguished Scientist at FHI firstname.lastname@example.org
Dr. Kaunitz receives grant or research support from Bayer, Agile, Noven, Teva, and Medical Diagnostic Laboratories, is a consultant to Bayer, Merck, and Teva, and owns stock in Becton Dickinson.
Dr. Grimes reports no financial relationships relevant to this article.
The Food and Drug Administration (FDA) should remove the black-box warning regarding skeletal health that the agency inserted into labeling for the injectable contraceptive depot medroxyprogesterone acetate (DMPA; Depo-Provera) in 2004. The black box 1) indicates that use of DMPA for longer than 2 years may reduce peak bone mass and place a woman at increased risk of osteoporotic fracture and 2) suggests that ObGyns order bone-density assessment in women who use DMPA long-term.