What risks does the FDA still note for HRT

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.

According to FDA.gov, hormone replacement therapy carries these key noted risks: blood clots, stroke, heart attack, breast cancer, endometrial cancer (if estrogen is used without progesterone and you have a uterus), dementia risk in women who start after age 65, and gallbladder disease. 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.

More Detailed, Clear Explanation

According to the WHI, the FDA's risk guidance is based on older, high-dose oral hormone studies, but these findings still form the official guidelines. Here is what each risk means in plain language:

• Blood clots: Oral estrogen may make the blood slightly "stickier," which may lead to clots in the legs or lungs. Transdermal estrogen (patch/gel/spray) has a much lower noted clot risk because it bypasses the liver.
• Stroke: According to FDA Drug Safety Communication, there is a very small increased risk, again mainly associated with oral estrogen. The risk appears lowest when a woman starts HRT before age 60 or within 10 years of menopause.
• Heart attack: According to the WHI, a slight increase in risk was observed when therapy is started after age 60. Starting earlier may show neutral effects; a qualified prescriber should evaluate individual cardiovascular risk factors.
• Breast cancer: According to the WHI, estrogen-progestin therapy may slightly increase risk over several years of use. Estrogen alone (for women without a uterus) did not increase breast cancer in large studies and may be associated with a lower rate. The increase with combined therapy observed in studies was small in absolute terms.
• Endometrial cancer: According to FDA-approved prescribing information for estrogen products, estrogen alone may thicken the uterine lining. Adding progesterone is indicated to protect the uterus and reduce that risk.
• Dementia: According to the WHI Memory Study, increased risk was observed only in women who started oral estrogen after age 65. This pattern was not seen in women who started earlier.
• Gallbladder disease: According to FDA.gov, estrogen may make bile thicker, which may contribute to gallstones, especially with oral forms.

According to NAMS, when used at the appropriate time, in the appropriate dose, and often through the skin, the overall risk profile for hormone therapy may be favorable for many women. A qualified prescriber should evaluate individual risk factors before initiating therapy. The FDA lists these risks to support informed decision-making, not to indicate that hormone therapy is unsuitable for all patients.