Update: New Labeling for Hormone Replacement Therapies, January 2003
The FDA is requiring that makers of all estrogen and estrogen with progestin therapies used for the treatment of menopause change their labels to include a warning highlighting the increased risks for heart disease, heart attacks, strokes, and invasive breast cancer. The warnings are based on studies of Prempro and Premphase (estrogen and progestin therapy) and Premarin (estrogen only therapy), but are believed to apply to all hormone replacement therapy.
This new warning must also emphasize that these products are not approved for heart disease prevention.
Results of the Women’s Health Initiative study reported in July 2002 warned that the risks of estrogen with progestin therapy outweighed the benefits. New studies find that the risks of estrogen therapy also outweigh the benefits.
Because of the risks, the FDA recommends that estrogens with or without progestins should be prescribed only at the lowest effective doses and for the shortest duration possible to meet the needs of the individual woman.
If you are using, or considering the use of estrogen or estrogen-progestin treatment, you should speak with your doctor about the implications for you of this new warning. Weigh the risks and benefits before you decide whether or not you should use these drugs.
For more information, read CPR's articles on hormone therapy, and check out the FDA webpage for detailed information: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00863.html
