HRT Update
(BIG NEWS) FDA Initiates Removal of Black Box Warnings from Hormone Replacement Therapy Products
We are excited to share recent comments from the FDA regarding Hormone Replacement Therapy (HRT). After reviewing data from current relevant literature, the FDA is recommending labeling revisions as summarized below.
- The FDA is requesting that companies make changes to the labeling to provide current, accurate and balanced information about the benefits and risks of these drugs, so women, in consultation with their healthcare providers, can make the best decisions for their health.
- The FDA has initiated removal of the “black box” warnings on most HRT products used for menopause to remove references to risks of cardiovascular disease, breast cancer, and probable dementia.
We are optimistic that this change may reduce stigma and fear around HRT – making more patients and clinicians open to discussing it as a legitimate therapy, rather than a “last resort.”
- HRT is FDA-approved for relief from common menopausal symptoms, such as hot flashes and night sweats and symptoms due to changes to the vagina, vulva, and urinary tract caused by decreased estrogen.
- An analysis of 30 trials with 26,708 women participants found HRT was not associated with increased cancer mortality. In fact, women who start HRT before age 60 appear to have a decreased mortality risk.
- Studies show that starting HRT within ten years of the onset of menopause can have numerous benefits, including a reduced risk of all-cause mortality and fractures, 50% reduction in heart attack risk, 64% reduction in cognitive decline, and 35% lower risk of Alzheimer’s.
If you or your provider has any questions, we are here to help! Mix Pharmacy has been compounding hormones for over 15 years, and our experienced pharmacists can help educate you on HRT.
References:
Compounded medications are not reviewed by the FDA for safety and efficacy
