The Health Ministry will soon be issuing new instructions for the labeling of estrogen and progestin products for use by postmenopausal women, in line with the new changes that the U.S. Food and Drug Administration announced on Wednesday, the ministry said yesterday.
The new boxed warning announced by the FDA - the highest level of warning information in labeling - highlights the increased risks of heart disease, heart attacks, strokes and breast cancer. It also emphasizes that these products are not approved for heart disease prevention.
Until recently, physicians all around the world believed that hormone substitutes not only handled menopausal symptoms, such as hot flushes, night sweats, vaginal dryness, itching and burning and prevention of postmenopausal osteoporosis, but also helped to ward off heart disease and wrinkles.
Changes in the FDA's instructions come after the Women's Health Initiative study (WHI) - a landmark study that indicated that estrogen with progestin increases the risk of both cardiovascular disease and breast cancer.
The FDA did not change the indication for using estrogen and progestin in the case of moderate to severe vasomotor symptoms (such as hot flushes) associated with menopause. Otherwise, the recommendation is to consider alternatives.