A recent move by the US Food and Drug Administration (FDA) to remove 'black box' warnings from most menopausal hormone replacement therapy (HRT) products could lead to a surge in the number of women seeking this therapy, according to UAE experts, with some describing it as a“pivotal moment” for older women.

For decades, women have used these HRT products to relieve menopausal symptoms. However, their use plummeted in the early 2000s when the FDA applied boxed warnings following a study that found a statistically non-significant increase in the risk of breast cancer diagnosis, according to FDA. The label cautioned users that HRT might increase the risk of serious and potentially life-threatening conditions.

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“This development signifies a pivotal moment for women in the UAE, potentially leading to increased access to evidence-based menopausal care and conversations with healthcare providers about personalised treatment strategies,” said Dr. Aysha Salam, Specialist Obstetrics and Laparoscopic Gynaecology at Aster Hospital Mankhool.

“It is highly probable that patient demand for HRT in the UAE will experience a notable surge. It empowers women to make informed decisions about their health, moving away from a one-size-fits-all approach to menopause management.”

Dr. Milena Caccelli, Endocrinologist at metabolic, said that the step will restore confidence among clinicians and patients.“For more than 20 years, the boxed warnings created disproportionate fear around hormone therapy, often overshadowing its substantial benefits,” she said.“The updated FDA stance recognises the refined evidence showing that when HRT is started within 10 years of menopause or before age 60, it has a favourable risk-benefit profile.”

She added that the move will promote more individualised prescribing and support wider and more appropriate use of HRT for women who can benefit from it.

'Lifesaver'

Many residents welcomed the FDA decision wholeheartedly.

Dubai resident Fathimath Shehnaz said HRT was a“lifesaver” for her symptoms after a hysterectomy surgery.“The hot flashes were unbearable afterwards,” she said.“My surgeon said there was no need for me to take HRT, but I was suffering every day. Soon afterwards, I went for a holiday to Switzerland with my family. It was December and the temperature was in the negative, but I couldn't even wear a jacket. That is when my family and I realised how bad my symptoms were.”

She said that as soon as she returned to Dubai, she sought medical help.“The doctor prescribed HRT and within one day I could feel the difference,” she said.“I also started taking sage tea and reduced the amount of medication. Within three months, I was able to wean myself off the medicine without any issues.”

According to Dr. Milena, menopause can trigger profound changes in women's everyday lives including mood swings, night sweats, weight gain, and hot flashes.“Women often feel embarrassed and ashamed to discuss their symptoms with a physician,” she said.“They also fear the side effects or the risk of cancer, cardiovascular disease, or thrombosis that box warnings previously described. Because of these concerns, they avoid or even delay seeking appropriate medical treatment.”

Misconceptions

The FDA website now states that studies have provided evidence that starting HRT within ten years of the onset of menopause can have numerous benefits which for most women outweigh potential risks. It notes that HRT has also been associated with 50% reduction in heart attack risk, 64% reduction in cognitive decline, and 35% lower risk of Alzheimer's.

Despite this, experts say that they continue to see patients who believe in these misconceptions.“Some patients believe that HRT always causes cancer, it increases the risk of heart attack or stroke at any age, all HRT products carry the same risks or even that menopause symptoms are just something to tolerate,” said Dr. Milena.

Dr. Aysha said that one prevalent misconception is the enduring fear of breast cancer, stemming from early interpretations of a study.“Despite subsequent reanalysis clarifying that risks are minimal for most women under 60 or within 10 years of menopause, the misconception continues,” she said.“Some patients mistakenly believe that HRT is solely for older women, unaware that its benefits are often maximized when initiated closer to the onset of menopause. This misapprehension often leads to delayed treatment initiation, potentially diminishing its efficacy for managing vasomotor symptoms and preventing bone mineral density loss.”

Dr. Milena concluded that the move by FDA would encourage more informed decision-making between women and their healthcare providers, provide greater access to safe and effective treatments, reduce fear caused by outdated risk messaging, improve quality of life and give better prevention of osteoporosis, cardiovascular decline, and cognitive changes.

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