Hormone Therapy
After a study which showed a significant increase in the risk of cancer in women who take hormone replacement therapy. The FDA has made it mandatory that the manufacturers of these products list the potential hazards of taking these products.
The study found that there is a significant increased risk of heart disease and breast cancer from using therapies combining the hormones estrogen and progestin. It also concluded that these risks far outweigh any health benefits.
The FDA approved new labels for Wyeth Pharmaceuticals maker of the best selling hormone brands. The labels include a boxed warning that highlights the increase for heart disease, heart attacks, strokes, and breast cancer. The new labels also emphasize that these hormone products are not approved for the prevention of heart disease.
The aborted study was studying the effects of combining estrogen with progestin.
The FDA also said it was asking all manufacturers of estrogen and estrogen-progestin products to add similar warnings and to change the enclosed patient information leaflet because all hormone products are believed to carry similar health risks.
Posted
by Dr. Steven Felder