What does the FDA say about HRT cancer risk

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According to FDA.gov, estrogen alone may slightly raise the risk of uterine cancer if the uterus is still present, and estrogen plus progestin may slightly raise the risk of breast cancer when used for several years. These risks are real but generally described as small, and FDA guidance notes that hormone therapy remains appropriate for many women when used at the lowest effective dose for the shortest time needed for symptom relief.

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.

How the FDA describes estrogen-only therapy

According to the FDA-approved prescribing information for systemic estrogens, when a woman still has her uterus, estrogen alone may stimulate the uterine lining. Over time, this may increase the chance of endometrial cancer. This is why the FDA requires that women with a uterus receive a progestin along with estrogen. Progestin protects the lining and may significantly lower this risk.

According to FDA.gov, in women who have had a hysterectomy, this uterine risk does not apply, so estrogen alone is acceptable.

How the FDA describes combined estrogen-progestin therapy

According to the FDA-approved prescribing information for combined estrogen/progestogen products, using estrogen plus progestin for several years may slightly increase the chance of breast cancer. This risk grows slowly over time and is generally described as small. According to FDA.gov, once therapy is stopped, the risk gradually returns toward baseline.

According to FDA Drug Safety Communications, this risk varies from woman to woman and depends on personal factors such as age, breast density, weight, and family history. All clinical decisions should be made with a qualified prescriber based on individual risk factors.

What the FDA wants every woman to know

• According to FDA.gov, hormone therapy is effective for hot flashes, night sweats, sleep disruption, and vaginal dryness.
• Most cancer risks are dose-dependent and time-dependent: lower doses and shorter use are generally associated with lower risk.
• There is no one-size-fits-all rule. For many women, the benefits may outweigh the risks.
• You and a qualified prescriber should review symptoms and health history each year to keep therapy appropriate for your situation.

According to FDA.gov, the agency acknowledges small cancer risks with specific forms of hormone therapy, but does not discourage treatment. Instead, FDA guidance encourages informed, individualized use so women may receive symptom relief while understanding the associated risks.

Important note: According to the FDA-approved prescribing information for systemic estrogens and combined estrogen/progestogen products, these carry boxed warnings regarding increased risk of breast cancer (with combined therapy) and endometrial cancer (with unopposed estrogen in women with a uterus). Clinical decisions about hormone therapy and cancer risk should be made with a qualified prescriber based on individual risk factors.