By Karen Kier, Pharmacist on behalf of the ONU HealthWise team

In June of 1978, the rock band Foreigner released their second studio album titled Double Vision. One of the singles on this album was Hot Blooded, which was certified as platinum. The album was released by Atlantic. Foreigner is one of the top-selling bands in the world with record sales exceeding 80 million, and they were inducted into the Rock & Roll Hall of Fame on October 19, 2024.

Menopause treatment has recently been a hot topic in the news due to labeling changes to hormone replacement therapy (HRT) for managing symptoms. Menopause usually occurs around the age of 50 to 52 years and is defined as the stage of a woman's life when her menstrual periods stop permanently for at least 12 months, and she can no longer get pregnant. The period of time before menopause is referred to as perimenopause. 

Perimenopause is the transitional phase when estrogen levels start to drop or decline until menopause is reached. This period is marked by hormonal fluctuations, causing symptoms like irregular periods, hot flashes, mood swings, and sleep disturbances. Perimenopause usually starts around 40 years. These symptoms can be mild to severe. We have no way to predict who will have more severe symptoms.

HRT is the use of the hormone therapy such as estrogen or progestins, or both, in managing symptoms of menopause. On November 10, 2025, the FDA announced the removal of the black box warning on prescription estrogen therapy. 

A black box warning from the FDA is considered the most serious alert for a drug, requiring manufacturers to put the warning on product labeling.  A black box warning indicates a serious risk of a potential adverse outcome.  A black box warning does not stop a prescriber from using the drug as long as they are monitoring the patient. 

In 2003, the FDA issued a black box warning for all prescription estrogen products approved for menopause.  This warning was based on evidence from a large clinical trial called the Women’s Health Initiative (WHI), which was published in 2002. The WHI was designed to study HRT and its impact on chronic diseases such as heart disease, stroke, and cancer.

WHI results showed an increased risk of heart disease, breast cancer, stroke, and blood clots for postmenopausal women using combined estrogen and progestin therapy. The estrogen product used in WHI was conjugated equine estrogens (brand name of Premarin). The progesterone product was medroxyprogesterone (Provera).  The researchers noted that while HRT should not be used to prevent chronic diseases like heart disease in older women, it is effective for managing menopausal symptoms like hot flashes and night sweats, especially for women in early menopause (under 60). 

Due to the release of this WHI data and the FDA warning, many women, in consultation with their healthcare providers, stopped taking HRT to manage menopause symptoms in 2003.  

In addition to the overall WHI data, 2 sub-studies were done to evaluate the use of HRT in reducing or preventing cognitive decline and memory.  These studies only evaluated women over the age of 65, and they looked at multiple memory and cognitive tests.  The results showed no benefit in adding HRT for memory, with one of the studies showing a slight decline in function. 

Based on these results from 2002 and the warning in 2003, one might wonder why the swift change in November of 2025? The black box warning has been removed from HRT labeling and several individuals claimed data proving a life-altering benefit of adding an additional 10 years of healthy life to every woman. There were claims in the news that estrogen was the most effective longevity agent for women.

New data has been evaluated and released including reanalyzing data from the original WHI study in younger women.  This new information provides promise, but only for women less than 60 years of age and ideally, in those women who start HRT during perimenopause.  Unfortunately, the data does not support the claims of an additional 10 years of healthy life and as the best longevity agent for women.

How do we take this information and apply it the best way possible?  Using the evidence and the new data, younger women (less than 60 years of age and those with perimenopausal symptoms) would have the most benefit. In women with significant quality of life issues related to menopause such as hot flashes, vaginal dryness, and painful intercourse, they should talk to their prescriber about options including HRT.  HRT does not seem to offer much benefit to women over 60 years of age.

Please discuss menopause issues with your healthcare providers especially if you are having symptoms. 

Happy Holidays from the ONU HealthWise team!