A Big step forward for women’s health
The FDA just updated the labeling on HRT products approved to treat the symptoms of menopause by removing certain warnings, and it’s a big step forward for women’s health.
For years, providers have recognized what the FDA review of the data now confirms: FDA approved hormone therapy products are a safe, effective option when prescribed for the right woman at the right time. The FDA’s labeling changes remove warnings that once caused hesitation for prescribers and patients, and the FDA’s actions provide greater confidence in using these products that may provide a number of health benefits.
For more information, read the full FDA press release here.
What Changed?
Before
Several “black box” warnings for risks of cardiovascular disease, breast cancer, and probable dementia and endometrial cancer for systemic estrogen-alone products on FDA approved products to treat the symptoms of menopause.
After
The FDA has requested that the manufacturers of the FDA approved HRT products remove the “black box” warnings for for risks of cardiovascular disease, breast cancer, and probable dementia.
The FDA has not requested manufacturers remove the “black box” warning for endometrial cancer for systemic estrogen-alone products
The FDA statement encourages women to have discussions with their health care providers based on the data and removing the stigma of HRT for whether these products are appropriate for them.
What This Means for Clinical Practices
This change opens the door for more balanced conversations between providers and patients about using these products. It allows you to discuss therapy based on the FDA’s recent review of the data and to consider whether the FDA approved products are appropriate for your patients.
How ReviveRX Supports Providers
At ReviveRX, we partner with clinicians to create compounded hormone formulations that fit the individual if the FDA approved product cannot be used for your patients. Our pharmacists are available to consult with you about selecting and designing the most appropriate formulation for your patient’s individual needs.
Learn more today
If you’d like to discuss how these updates may influence your prescribing approach or explore personalized formulations for your patients, our team is here to help.
Women’s Wellness Toolkit
visit our Women’s Wellness Toolkit for educational resources.