US approves new drug for hot flashes: How this will help women

Good news for women – the US Food and Drug Administration has approved a new drug for hot flashes. The new drug, fezolinetant, may potentially be a game-changer for women. Let’s take a closer look: What are they? Hot flashes occur during menopause – a normal stage of life women go through in their mid-to-late 40s.

Around 85 per cent of women say they have experienced hot flashes during menopause.

According to the National Institute of Aging, menopause usually lasts seven years, but can continue for up to 14 years. During this time, a woman’s body produces less estrogen and progesterone. According to WebMD, no one knows the reason for hot flashes, but it has been theorised that this has something to do with the drop in estrogen. How do they feel? According to the Medical News Today website, hot flashes are unpleasant sensations of heat in the chest, arms, neck and face. Lasting between 30 seconds and 10 minutes, they can also speed up the heart rate. Hot flashes can happen several times in an hour, a couple of times a day or even less than once a week. During a hot flash, blood vessels in the affected areas actually expand – which results an increased flow of blood.

This can result in the skin being flushed or blotchy patches breaking out.

Some people also feel anxious and stressed during a hot flash especially if they are out in public. At the end of a hot flash, the affected person may sweat in a way that makes them feel cold or shiver. [caption id=“attachment_12616942” align=“alignnone” width=“640”] No one knows the reason for hot flashes. AFP[/caption] This comes as the body looks to cool itself. It is important to note that neither hot flashes nor menopause are symptoms of a serious disease. What can be done to avoid them? While hot flashes cannot be prevented, there are certain triggers that can be avoided, as per WebMD. These include

• Stress
• Caffeine
• Alcohol
• Spicy foods
• Tight clothing
• Heat
• Cigarette smoke

The effects of hot flashes can be countered by staying cool – for example wearing lightweight, loosely-fitting clothing ideally made out of cotton, as per WebMD. Another way to counter it is to practice deep breathing morning and evening for 15 minutes and then try it when a hot flash begins. Exercising, taking walks, swimming, cycling and dancing are all good options, as per WebMD. Why is this drug a big deal? Because hot flashes have real-life implications for many women. “Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” Dr Janet Maynard of the FDA was quoted as saying by CNN. Diane Hoard, who experienced hot flashes after menopause, told NBC she had her coat ‘wide open’ on a wintry day. “I had sweat running down my forehead. I was miserable.” “It’s just affecting my life tremendously,” she said. [caption id=“attachment_12616962” align=“alignnone” width=“640”] Exercising can be a good way to try to offset hot flashes. Wikimedia Commons[/caption] An estimated 21 million women in the United States will have those symptoms by 2025, Astellas Head of BioPharma Development Marci English told Reuters ahead of the approval. Claudia Mason, MD, an ob-gyn at Cleveland Clinic agreed.

“They can be quite disruptive,” Mason told Self.com.

“They can mess with your sleep and just be super uncomfortable in general”. Mason told the website that though Hormone Replacement Therapy (HRT) is used to treat many women, it isn’t recommended for everyone. Those with breast, ovarian, or uterine cancer, for example. Or those with untreated high blood pressure, blood clots, stroke, or cardiovascular issues. “It’s great to have an option that’s non-hormonal” for people who can’t start—or haven’t had success with—HRT,” Mason added. Simply put, it gives women another option. Women like Hoard, who had to get off HRT after being diagnosed with cancer. She says her hot flashes returned with ‘a vengeance’ – every 30 minutes which shattered both her concentration and sleep. “I’m looking to just have some normalcy back in my life because it’s been debilitating for me,” Hoard added.

“I’m so excited about this FDA ruling,” Dr Mary Rosser told NBC.

Rosser, an assistant professor of women’s health at the Columbia University Vagelos College of Physicians and Surgeons and director of Integrated Women’s Health at Columbia, added, “We’re talking about something that is going to be powerful." “I think at the end of the day, it’s always good that women have more options, so I’m happy to see that there’s been further development in an overlooked field, and that is menopausal medicine. And that for women to have more options is always a good thing,” Dr Stephanie Faubion, director of the Mayo Clinic’s Center for Women’s Health, told CNN. “Does that mean we’re going to abandon all existing therapies and head to this as the answer for everyone? No. And we still have a lot more to learn about this class of medication, but it’s excellent that we have choices.” “The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women,” Maynard added.

But the medication isn’t a silver bullet either.

Phase 3 of the trial showed it alleviated hot flashes in 48 per cent of subjects on a higher dose and just 36 per cent in subjects on a lower dose. “I don’t see it as a replacement for estrogen,” said Dr Samantha Dunham, an adviser to the drug company told NBC. “I see it as a nonhormonal alternative for people who aren’t able to or don’t want to take hormone therapy.” Also, the drug isn’t cheap. It is set to cost $550 (Rs 45,000) for a supply that lasts 30 days. It also isn’t recommended with those with liver issues. The FDA has warned that people taking the pill be tested for liver damage or infection, with routine bloodwork done every three months for the first nine months of using the pill. Abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated liver enzymes, were the most common side effects of fezolinetant, according to CNN. With inputs from agencies

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