Susan G. Komen® Welcomes Removal of Black Box Warning from Some Hormone Therapies for Menopause

U.S. Food and Drug Administration Guidance Confirms Vaginal Estrogen Therapy Doesn't Increase Breast Cancer Risk

WASHINGTON, DC - Susan G. Komen^®, the world's leading breast cancer organization, today expressed its support for the removal of a black box warning label on vaginal estrogen therapies that help alleviate dryness and irritation caused by menopause. The label previously issued by the U.S. Food and Drug Administration (FDA) was a general warning that the use of any menopausal therapies containing estrogen, including vaginal estrogen creams, suppositories and rings, could increase a person's risk of breast cancer and other serious health conditions.

"This announcement is a win for women as it provides safe and effective options to relieve the pain and discomfort caused by vaginal dryness," said Dr. Sonja Hughes, vice president of community health at Susan G. Komen, and OBGYN. "We appreciate the FDA's thorough review of the impact that added hormones can have on breast cancer risk and the conclusion based on research and evidence that vaginal estrogen therapies do not appear to increase the risk of breast cancer or recurrence."

Black box warnings are designed to educate users about the risk of a product to one's health. They are added to items such as alcohol, cigarettes, medications and various consumer products. The FDA previously determined that the estrogen contained in vaginal therapies could have increased a person's individual risk of breast cancer or a breast cancer recurrence.

Some of the therapies used to treat breast cancer can force a woman into early menopause, far sooner and faster than natural menopause would occur. Because the onset of this type of menopause is sudden, symptoms such as vaginal dryness may be worse than with natural menopause, and any menopausal symptom can negatively impact a person's quality of life.

"Maintaining a good quality of life is a major concern to breast cancer patients and survivors," Hughes added. "We want people to feel confident about making health care decisions with their providers based on research. Anyone experiencing vaginal dryness and discomfort should talk with their health care provider and find a treatment that's best for them."

The FDA's decision does not impact the label of estrogen plus progestin menopausal hormone therapy (MHT) taken orally. Current research shows MTH therapies do increase a person's risk of breast cancer, and it is recommended that women use the lowest dose of MHT that eases symptoms for the shortest time needed, if recommended by their doctor. However, ongoing research is needed to fully understand this complex issue. Women's health has historically been under-researched and under-funded and deserves more attention to ensure that they can live their longest and healthiest lives possible.