The Food and https://www.qykfxx59.online
Drug Administration issued that bit of guidance, and announced new labeling requirements for estrogen and estrogen with progestin products, after reviewing data from a landmark study that raised concerns about the risks of using the popular pills
That study, sponsored by the National Institutes of Health, was halted abruptly last July after researchers found that the risks, particularly increased risk of heart attacks and breast cancer, from long-term use of the hormone replacement products outweighed the health benefits.
FDA Commissioner Scott McClellan said Wednesday that the agency was issuing revised consumer labeling to reflect the study findings and requiring all makers of estrogen and estrogen with progestin products, including patches and topical medications, to update their product labels.
The new labeling requirement includes a new boxed warning highlighting the increased risks for heart disease, heart attacks, strokes and breast cancer. The warning also emphasizes that these products are not approved
for the prevention of heart disease.
The patient information leaflet inside the product package also will be updated.
But McClellan also stressed that post-menopausal women who are confused about whether to continue the treatment consult their health care provider about what's best for them.
"There are risks and benefits that women need to consider in their individual circumstances," he said during a telephone conference call with reporters. "Women should consult their physicians and find the therapy regimen that works best for them."
Some 10 million post-menopausal women in the United States use estrogen and combination estrogen-progestin products to cope with the often uncomfortable symptoms of menopause, such as hot flashes and vaginal dryness, as well as to prevent osteoporosis, according to the FDA.
By Darlene Superville