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FDA Approves New Drug Veozah for Hot Flashes … Is It Safe?

FDA Approves New Drug Veozah for Hot Flashes ... Is It Safe?
FDA Approves New Drug Veozah for Hot Flashes ... Is It Safe?
Emma Yasinski
Emma Yasinski Staff Writer
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Margie Minkler started getting hot flashes in her early 40s. 

“It feels like a cartoon of somebody who is turning red from their toes up to their forehead, and then bursts out in sweat,” she says. “My face would be red as a tomato.” These hot flashes kept her up at night for years. Her primary care doctor told her she should “grin and bear it” for the next 10 years. 

At first, she did just that. But after three years of struggling, she mentioned her hot flashes to her gynecologist who prescribed a hormone-replacement lotion she could rub on her hips daily. 

“Within three days, I kid you not, all my side effects of menopause were gone,” Minkler says. 

But, after eight years using the lotion, she had to stop when her doctor found a lump in her breast. Her doctor worried the hormones in the lotion could raise her risk for breast cancer. 

“No one had told me that once you stop using that lotion, you get thrown right back into the middle of menopause!” she says. Her hot flashes came rushing back, but she’s grateful they only lasted another four to six months to the end of her menopausal experience. 

For those seeking an answer to hot flashes, the FDA approved Veozah (fezolinetant), in May 2023. The non-hormonal drug was tested in people with moderate to severe hot flashes. Moderate hot flashes are defined as those that cause both heat and sweating, but do not prevent you from continuing daily activities. Severe hot flashes are those that cause heat and sweating intense enough to cause you to stop current activities. Any hot flash that causes you to wake up during the night is considered severe. 

Minkler says she’s not sure if she’d ask for the drug if she were having hot flashes today. 

“I have become a little more resistant to trying drugs without doing a lot of research, but I would be interested in researching that and pursuing it,” she says.

In the year-long clinical trial, published in The Lancet, participants reported fewer hot flashes within just a week of starting the medicinal therapy, but trial participants were only tracked for about a year so far, so we will learn a lot more about potential side effects of Veozah in the next coming years. Researchers typically find new safety risks in about 30 percent of newly-approved drugs within 10 years of their FDA approval.

What Are Hot Flashes?

Hot flashes are the most common complaint women express during the transition to menopause. Menopause is the time in a woman’s life when levels of reproductive hormones, such as estrogen and progesterone, drop, and she gradually stops releasing eggs from her ovaries. During this time, her periods become unpredictable until they stop entirely.

While we typically associate menopause with our reproductive organs, the process is actually guided by the brain. Deep in the center of the brain are the hypothalamus and the pituitary gland, both of which control the release of these hormones in your body. To do so, they sense and react to levels of hormones already in the body, such as estrogen.

The hypothalamus also controls your body temperature. That’s where the hot flash “trouble” starts.

“The neurons that control our reproduction get huge. They just get massive, like 100 times bigger than they are normally because they are trying so so so hard to release an egg,” explains Susan Reed, MD, MPH, a professor of obstetrics and gynecology at the University of Washington. Because of this, “they throw off the temperature controlling area of the brain.”

Reed adds that, while most of us think of hot flashes as making us exceptionally warm, people going through menopause often also feel very cold. Then when the body tries to compensate by warming you up, you end up with a hot flash. 

“It’s just a dysregulation of the [body’s] temperature, and that’s what the hot flash is,” she says.

The main treatment for hot flashes, prior to Veozah’s approval, has been hormone replacement therapy (HRT), a treatment in which you take estrogen and progesterone to bring your levels closer to where they were before you started the menopausal transition. For several years, scientists were concerned that the hormonal treatment raised women’s risk of heart disease and breast cancer. After years of additional studies and reanalyzing data, scientists agreed that the treatment does not lead to these conditions.

Still, there are some specific people, such as breast cancer patients, for whom HRT is not a safe option, and many more who are wary of taking hormones even if they don’t fall into a known high-risk population. That left women with few options for treating hot flashes.

How Veozah Works

Veozah is not a hormonal drug. It binds to a receptor that’s found on the brain cells in your hypothalamus. Receptors are like locks, for which certain molecules act as keys. When a molecule finds a receptor on a cell that it fits into, it binds to it, sending a message to the cell. These messages tell your cells to start or stop the many processes that keep your body functioning smoothly.  

Most of the molecules that bind to receptors are made naturally in your body, but some can come from drugs.

When Veozah finds and binds to the right receptors in the brain, it stops the hypothalamus from trying so hard to regulate your body temperature, so you don’t feel such strong swings between cold and hot.

Side Effects of Veozah for Hot Flashes

There are many different types of receptors found on many different cells in your body. The type of receptor that Veozah binds to is called a “neurokinin 3” receptor. They’re found on brain cells in the hypothalamus, but some other cells throughout the body also have these types of receptors.

Since scientists can’t always control exactly where a drug travels in your body, sometimes it finds receptors that it can bind to outside of the brain. For example, one organ that happens to have a lot of neurokinin 3 receptors is the liver. That’s why one potentially dangerous side effect of Veozah is liver damage. 

“The FDA is recommending that all clinicians do baseline testing for liver abnormalities to make sure that the [patient’s] liver is healthy to begin with. And they are recommending that clinicians test blood through blood work every three months, for the first nine months, to make sure that we don’t see changes in the liver [function or health],” says Reed. “And that’s really due to the fact that the liver is full of receptors where this drug can attach.”

Other Side Effects of Veozah

Some less dangerous side effects reported in the clinical trial included: 

  • Abdominal pain
  • Diarrhea
  • Insomnia 
  • Back pain

When Can I Stop Taking Veozah?

Trial participants saw fewer hot flashes within a week of starting the drug. However, if you stop taking it daily while you’re still experiencing the menopausal transition, your hot flashes will come back. On average, hot flashes last about seven to eight years, but the actual range for each woman varies widely from around four to 11 years, and over time they may become less intense.

Reed recommends that her patients take a “drug holiday” once a year. She instructs them to stop taking HRT or Veozah, for two weeks before their annual appointment. 

“They see how they feel. If they feel horrible, and they are getting hot flashes, and they’re happy on their drugs, they restart them,” she says. 

Be sure to talk to your doctor about using a drug holiday as a method for deprescribing. It can be dangerous or cause withdrawal symptoms if done with certain drugs such as antidepressants. You and your doctor together can create a safe tapering plan for deprescribing purposes.

Questions to Ask Your Doctor About Side Effects of Veozah

The clinical trial followed patients for one year, explains Reed. 

“We don’t have long term data,” she says. 

The FDA will continue to monitor reports about side effects and safety concerns with the drug, as it does for all new drugs, after it hits the market. It’ll be important to ask your healthcare provider how much researchers know about using the treatment for more than a year. Additionally, you can report any side effects you experience to the FDA to help them monitor and catch adverse effects that may not have appeared in the clinical trial here.

You should also ask about any risks specific to you, such as whether or not other drugs you’ve been prescribed could interact with Veozah and increase your risk of liver damage or other side effects. Be sure to also mention any family or personal history of breast cancer.

How to Treat Hot Flashes Naturally

Both Veozah and HRT are designed to be taken daily, to help prevent hot flashes before they happen. But if you do get hot flashes, Reed says there are a lot of things you can do to lessen their intensity while you’re experiencing them. 

“I don’t think we talk about that enough,” she adds.

Some of her suggestions included:

  • Placing your hands on a cold desk or take your shoes off and put your feet on cold tile. 

“We emit heat through the soles of our feet and palms of our hands,” she explains. Cooling them quickly can help.

  • Using neck fans
  • Using bed fans that go under the sheets
  • Wearing layers so you can add and remove clothing to adjust your temperature easily.
  • Practicing meditative techniques and breathing exercises. 

“It helps to not get angry that the hot flash is coming, rather just breathe and be more accepting of it,” Reed says.

MedShadow also reached out to some of our readers to ask how they managed hot flashes. Here’s what they had to say:

Carol Gee, an author, says that she still gets occasional hot flashes even though she finished menopause 11 years ago. She wears layers, and sometimes sleeps without clothing to help keep herself cool. 

She adds that she periodically takes black cohosh or Estroven [an over-the-counter, “natural” pill], supplements you can find at the pharmacy, but only when she feels she really needs them. [Editor’s note: supplements are not strictly regulated by the FDA. Make sure you’re reading labels to ensure you’re buying supplements that have been inspected by a third party.]

Leslie Shull, a health coach and yoga instructor, credits regular exercise, yoga, prioritizing sleep, and a healthy diet for the fact that her hot flashes don’t seem to be as intense and disruptive as those of her friends. Still, like many women, she recommends dressing in layers, staying hydrated, or carrying around a personal fan when the hot flashes do hit.

Minkler says she used cold towels around her neck and “lots of cold showers.” Other than that, she drank tea and took vitamins she was told would help. 

“Nothing seemed to work for me though,” she says of the home remedies.

 

Readers! Do you have tips for how to manage hot flashes? Have you tried prescription medications for them? Let us know in the comments! We may feature them in future additions to this article in the future.

DISCLAIMER: MedShadow provides information and resources related to medications, their effects, and potential side effects. However, it is important to note that we are not a substitute for professional medical advice, diagnosis, or treatment. The content on our site is intended for educational and informational purposes only. Individuals dealing with medical conditions or symptoms should seek guidance from a licensed healthcare professional, such as a physician or pharmacist, who can provide personalized medical advice tailored to their specific circumstances.

While we strive to ensure the accuracy and reliability of the information presented on MedShadow, we cannot guarantee its completeness or suitability for any particular individual's medical needs. Therefore, we strongly encourage users to consult with qualified healthcare professionals regarding any health-related concerns or decisions. By accessing and using MedShadow, you acknowledge and agree that the information provided on the site is not a substitute for professional medical advice and that you should always consult with a qualified healthcare provider for any medical concerns.

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