Does the FDA endorse HRT for symptom relief

DISCLOSURE: Voshell's Pharmacy is a licensed compounding pharmacy that prepares and sells compounded medications by prescription. As a provider of competing products, our perspective may be influenced by our professional and commercial interests.

Yes. According to FDA.gov, the agency has approved menopausal hormone therapy (HRT) for relief of moderate to severe menopausal symptoms such as hot flashes, night sweats, vaginal dryness, and painful intercourse.

What the FDA Endorses

According to the FDA-approved prescribing information for estrogen and estrogen-progestin medications, estrogen therapy, with or without progesterone, is an approved treatment for common menopausal symptoms. When the FDA approves a therapy, it means the agency has reviewed evidence showing that the treatment is safe and effective for the indicated use when used correctly and for the right patients.

According to FDA-approved product labeling, these medicines are approved to treat:

• Moderate to severe hot flashes (also called vasomotor symptoms)
• Night sweats
• Vaginal dryness, irritation, and painful intercourse
• Prevention of bone loss in postmenopausal women at risk of osteoporosis

According to FDA.gov, the agency recognizes that these symptoms may be disruptive, and that hormone therapy is an approved and appropriate treatment option for many women when prescribed by a qualified prescriber.

Compounded medications are not reviewed by FDA for safety or effectiveness before dispensing and are prepared by a licensed pharmacist only in response to a valid prescription for an individual patient. This page primarily discusses commercially available hormone therapy products.

What "Moderate to Severe" Means

• Moderate means symptoms interfere with daily comfort but you may still be able to function.
• Severe means symptoms may interrupt sleep, concentration, work, or quality of life.

According to FDA-approved prescribing information, if symptoms are intrusive, persistent, or exhausting, this may constitute a valid clinical indication for HRT as determined by a qualified prescriber.

Important FDA Guidance

• According to FDA.gov, the FDA recommends using the lowest effective dose for the shortest time needed to maintain comfort.
• According to FDA-approved prescribing information, for women with a uterus, estrogen must be paired with progesterone to protect the uterine lining.
• According to FDA.gov, vaginal estrogen for dryness may be used long term because the dose is very low and stays largely local.

In short, according to FDA.gov, the FDA supports the use of commercially available HRT for symptom relief when used as directed and when a qualified prescriber has determined it is appropriate for a woman's individual health profile.