FDA Chief: Warning Labels Deter Women from Menopause Hormone Therapy
The U.S. Food and Drug Administration (FDA) plans to remove “black box” warning labels on hormone therapy drugs related to menopause. This decision marks a significant shift aimed at encouraging more women to pursue hormone replacement therapy (HRT) for menopause and perimenopause symptoms.
FDA’s Reversal on Hormone Therapy Warnings
FDA Commissioner Dr. Marty Makary discussed the recent development in an interview with CBS News, describing it as an end to a long-standing “fear machine.” This change addresses the historical demonization of menopause hormone therapy, which Dr. Makary described as “an American tragedy.” He emphasized that HRT could greatly improve women’s health on a population level.
Health Benefits of Menopause Hormone Therapy
Numerous studies indicate that menopause hormone therapy can reduce the risk of heart attacks, which are the leading cause of death among women. The FDA’s announcement includes medications containing both estrogen and progesterone, as well as systemic and topical estrogen treatments. This marks a departure from earlier studies, notably from the Women’s Health Initiative in 2002, which many experts now criticize for overstating the risks associated with HRT.
- Recent findings suggest benefits, particularly for women using therapy before age 60.
- Hormone therapy can help reduce risks associated with cognitive decline and osteoporosis, improving overall quality of life.
- Common menopause symptoms include hot flashes, insomnia, and mood swings.
The Impact of Past Fear-Based Research
Dr. Makary noted that misguided fears since 2002 have led many doctors to dissuade women from considering hormone therapy. He estimates that between 50 and 70 million women have been deprived of the potential benefits of HRT over the last two decades. These include improved bone density and reduced risks of fractures, especially in postmenopausal women.
Recommendations and Considerations
It is vital for women considering hormone therapy to discuss options with their healthcare providers. Dr. Makary advised that the optimal time to begin HRT is within ten years of menopause’s onset, typically around age 50. Starting therapy too late, especially after age 60, may be less beneficial due to the aging process and its effects on cardiovascular health.
Alternative Treatments for Menopause Symptoms
While HRT is considered effective for managing hot flashes and night sweats, it is not the only option. The FDA recently approved Lynkuet (generic name: elinzanetant), a non-hormonal treatment that targets brain pathways linked to temperature control. This offers an alternative for women not suitable for hormone therapy, such as those with a history of breast cancer.
Changing Attitudes and Education
Historically, menopause has been overlooked in medical education. This gap is increasingly being addressed, with more women entering the medical field. Dr. Makary noted the shift at institutions like Johns Hopkins, where nearly half the medical students are female, bringing renewed focus to women’s health issues.
The FDA’s move to eliminate misleading warning labels is a progressive step. It underscores the need for increased awareness and understanding of menopause and the potential benefits of hormone replacement therapy.
