Local doctor weighs in on removal of ‘black box’ warnings from HRT products used to treat menopause

By: Nia Hinson

COLUMBIA, Mo. (KMIZ) -- A local doctor is hopeful a change in warnings on hormone replacement therapy for menopause will lead to more women exploring their options.

The Food and Drug Administration announced in November that it was initiating the removal of "black box" warnings hormone replacement therapy products for menopause. The FDA claimed the warnings were misleading and asked companies to remove references to risks of cardiovascular disease, breast cancer and dementia.

According to Dr. Lisa Brennaman, an OBGYN at MU HealthCare, a study performed in 2000 looked into the risks and benefits of the therapy using a large cohort of women. The biggest flaw in the study was that it contained a group of women that were of older age, leading to an increase in cardiovascular disease, dementia and the possibility of breast cancer.

Follow-up research was conducted that included a younger group of women, who were younger than 60 years old or within 10 years of the onset of menopause and found those risks were significantly reduced or nonexistent.

An analysis was then published in 2015, followed by observational studies which worked to strengthen data regarding the safety of HRT for the majority of women and leading to the FDA's announcement, according to Brennaman.

"There was a lot of associated media coverage when the findings were initially published in the early 2000s that resulted in a dramatic decrease in the prescribing of hormone replacement therapy," Brennaman said. "Literally within days to weeks of the published findings, women came to their doctors and abruptly stopped therapy and the rate of prescriptions of hormone replacement therapy plummeted drastically."

According to the National Library of Medicine, From 1999 to 2020, the prevalence of menopausal hormone therapy use decreased among women of all age groups, from 26.9% in 1999 to 4.7% in 2020.

Brennaman said she believed the hormone therapy was fairly uncommon for women about a year or two ago, but thinks it has risen dramatically in popularity since then as women have gained more awareness.

Brennaman said since the changes were made last fall, women's healthcare providers and physicians are trying to spread the word to women and doctors about the new safety data. She said the benefits of the therapy likely outweigh the risks for the majority of women younger than 60 years old or within 10 years of initiation.

It's also something Brennaman said physicians within the OBGYN women's health community have been lobbying for for a while, and view the change as a "win" for advancing women's health.

"Women come to my office and say to me often, 'I'm really suffering. Menopause is impacting my work and my family relationships but I'm so afraid of getting cancer.' So, I think there are a lot of fears and myths that women have regarding the risk of cancer...and now we know that the risks are actually quite minimal and the benefits are significant," Brennaman said.

What is HRT and how does it help?

Hormonal replacement therapy takes many different forms, depending on what symptoms women are trying to improve.

Generally, it's used to treat menopause, which refers to a 12-consecutive-month period when menstruation stops for women, which is on average at age 51. Physicians typically use estrogen to treat symptoms-- which can include hot flashes and night sweats-- although a form of progesterone is also used in women who still have a uterus.

Estorgen can come in the form of a pill, patch, gel or a vaginal ring and women typically see a 60% to 90% improvement in hot flashes and night sweats when using it, according to Brennaman.

Women will also typically see improvements in symptoms roughly within seven days of using HRT, followed by peak control with any initiation and dose change around eight to 12 weeks of therapy.

Menopause symptoms also include sleep disturbance, changes in cognitive function or brain fog and an overall decline in quality of life. Some women will also experience bone thinning or osteoporosis, urogenital symptoms or vaginal dryness.

Brennaman said there isn't a set amount of time that people should use the therapy, but said most women will use treatment for a number of years until they soften the transition to menopause. When treatment is stopped, a resurgence of symptoms is likely.

A slight increased risk of breast cancer is also possible for women who use estrogen and progesterone together for years. Brennaman said some women will choose to lower their dose, wean off of therapy or continue to use it for life.

Who should use it?

Although more research has been done striking down previous beliefs about HRT, doctors say the therapy should still be used on a case-by-case basis. According to Brennaman, HRT slightly increases the risk of having a blood clot in the legs or lungs and can also slightly increase the risk of irregular bleeding.

Women who have ever had a blood clot, have uncontrolled hypertension, significant lung disease or any form of active cancer should weigh those before being prescribed hormone therapy.

"Your physician or provider should sit down with you and review your medical history, exactly what symptoms you want to be targeting, your family history, your overall preventive care and then kind of arrive at an option that hopefully meets your needs in the safest way possible," Brennaman said.

Brennaman also said that cost is typically not a barrier for women who choose to use HRT. Oral pills are typically the cheapest form, while patch therapy tends to be more expensive. However, that is usually covered by most insurance plans.

A generic local topical estrogen cream used to treat genital urinary symptoms is also affordable, she said.

Most women can be prescribed HRT by their OBGYN, but can also receive it from general practitioners who do a significant amount of women's health within their practice.

Brennaman said she recommends people consult a physician before using products to treat menopause and said she doesn't think it's necessary for all women, but thinks people should ask for help sooner, rather than later.

"I think patients who are having symptoms do not need to wait until the time of severe disability or negative consequences like job loss, relationship loss, sleep exhaustion, osteoporotic fracture before they seek help," Brennaman said.