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| (Amanda Gorman: Art by Tamika Cody) |
In a consumer update posted on its website, the agency said it has requested that manufacturers remove language about cardiovascular disease, breast cancer, and probable dementia from the boxed warning on menopausal hormone therapy drugs. Boxed warnings are the FDA's most prominent safety alerts.
The risks would still appear in the drugs' warnings and precautions sections. The FDA said the proposed labeling changes are intended to give patients and health care providers updated information about the benefits and risks of hormone therapy.
One warning would remain. The FDA said it is not requesting the removal of the boxed warning about endometrial cancer risk for systemic estrogen-alone products.
Menopause typically occurs between the ages of 45 and 55 and can cause symptoms such as hot flashes, night sweats, vaginal dryness, and sleep disruption. Hormone therapy is one option used to treat those symptoms.
The agency said millions of women avoided hormone therapy after studies in the early 2000s raised concerns about cancer and heart disease risks. Updated labeling, the FDA said, may help women and their doctors make more informed treatment decisions.
Read the FDA's full consumer update here:
Source:
Food & Drug Administration Consumer Updates
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