For many middle-aged women who experience hot flashes, the new drug Veozah has been a life-changer, taming the heat of menopause symptoms without hormones. A string of cautionary messages about its risks of liver injury, including a heightened warning last month, doesn’t seem to be dampening that enthusiasm, say some Atlanta doctors who continue to prescribe fezolinetant, sold as Veozah.
“It’s the first non-hormonal drug developed specifically for the issue of menopausal hot flashes,” said Atlanta OB-GYN Melissa Counihan.
Counihan isn’t deterred by her colleagues’ decisions to take patients off the medicine when blood tests reveal elevated liver enzymes, which indicate a potential health risk. Counihan and other Georgia doctors say they frequently test their patients’ blood for liver issues and haven’t experienced any negative reactions to the new drug.
“It may not be a perfect drug, but hopefully there will be more drugs down the line and safer options,” Counihan said.
Hot flashes are a sudden, intense sensation of heat in the upper body, particularly the face, neck, and chest. The flashes of heat are among the most common symptoms that arise from losing hormones such as estrogen during the aging process, a period known as menopause that marks the end of a woman’s menstrual cycle around age 50.
More than 1.3 million women in the U.S. enter menopause every year, according to the National Menopause Foundation. Up to 80% of women in menopause experience hot flashes, which can last 7 to 10 years, The Menopause Society reports.
In September, the FDA issued a safety warning about the drug after reviewing a report of a patient with elevated liver blood test results and signs and symptoms of liver injury after taking the medicine for about 40 days. The FDA also recommended testing the blood at regular intervals. Then on Dec. 16, the agency added a boxed warning, its most prominent warning, to Veozah labeling. The requirement calls for a box around the liver injury warning near the beginning of the package insert.
There are few effective non-hormonal options for women with moderate to severe menopause symptoms such as hot flashes. But that’s slowly changing as more options are studied and approved.
In October, the FDA accepted an application from Bayer to develop Elinzanetant, which like Veozah blocks receptors in the brain that become “hyperactivated,” or overstimulated from a lack of estrogen, which leads to the symptoms, according to Dr. Yesmean Wahdan, vice president of Bayer’s US medical affairs and women’s health.
Credit: Coutesy Bayer
Credit: Coutesy Bayer
Elinzanetant differs from Veozah by addressing sleep disturbances in addition to hot flashes and night sweats.
Participants in clinical trials involving the new medication did not show any liver injury or other significant negative impacts, according to a study published in the JAMA Network. The study also found that the medication was safe and helped improve the frequency and severity of menopause symptoms such as hot flashes and sleep disturbances.
Bayer expects the FDA to approve the new non-hormonal product in the second half of the year.
“For so long women have been told that menopause is normal, even though these women have consistently reported symptoms and described not feeling like themselves. They have to deal with it because … this is natural,” Wahdan said. “Women are saying these symptoms are debilitating and we need real options.”
Last year, the Women’s Health Initiative reversed its 20-year-old findings on the risks of hormone replacement therapy, HRT, to relieve menopause symptoms such as hot flashes.
The following day, Oscar-winning actress Halle Berry shouted “I’m in menopause” from the U.S. Capitol in support of a $275 million federal funding bill for more research, training and awareness about the often misunderstood and stigmatized women’s health condition.
But doctors still are cautious about recommending HRT to women with family history of cancer.
“A have a lot of patients who, because of family history or personal history, are nervous about the hormonal option,” said Sara Morris, an OB-GYN with North Atlanta Women’s Specialists. “For some it works really well.”
Credit: Karen Rubin Photography
Credit: Karen Rubin Photography
Meanwhile, Morris isn’t alarmed by the warnings about Veozah. Her patients don’t seem hesitant to take the medication because of the warnings, she said, and they haven’t encountered any issues. So she continues to prescribe Veozah after checking bloodwork and ensuring there are no conditions or medical history that would prevent them from taking it.
Most patients are more concerned about the high cost of the drugs because insurance often doesn’t cover it, Morris said.
Nonhormonal options for vaginal dryness seem to work well, but finding what works for hot flashes requires taking a new product for several months, she said. For example, some of her patients have found success with the supplement Thermella.
For the majority of her menopause patients, Counihan finds that HRT is the safest and most effective option. She received requests for the drugs and recommended them even before the WHI changed its stance on their safety. “The problem is that HRT does work, but it’s finding the right dosage and combination (of hormones) for the patient.”
Patients with a personal history of breast cancer and others who still fear the risks of taking hormones have also found success with Veozah, Counihan said. Some of her colleagues at Peachtree Women’s Specialists have had to take patients off the drug because of elevated liver enzymes without other symptoms, but none of her patients haven’t experienced any issues. “I still offer the drug to appropriate candidates and follow the FDA guidance regarding monitoring liver function.”
The FDA’s drug safety warning in September advised increased blood testing for the first two months after starting Veozah and then at three, six and nine months. Patients should stop taking the medicine immediately and contact medical professionals if they experience signs and symptoms of liver injury such as fatigue, nausea, itching, and yellow eyes and skin.
Despite the consistent liver monitoring, LaGrange OB-GYN L. Joy Baker said she’s become a big fan of Veozah. “It’s the first we have seen that gives more relief from hot flashes. I have been very excited about it. Not everyone is a good candidate for it but if they are, it’s a viable option.”
Baker said her patients at Wellstar West Georgia Medical Center have not been deterred by the liver warnings.
Credit: Wellstar Health System
Credit: Wellstar Health System
“Women with severe menopause are weighing the risks and benefits of medications that can dramatically improve quality of life. Many women tell me they are fine with accepting some level of risk to feel Ike themselves again.”
Counihan welcomes the new options to treat menopause and expects further alternatives in the future through increased funding for women’s health initiatives.
“Historically, women’s health issues have largely been ignored by the pharmaceutical industry. Lately, there has been a big push to shine a light on the symptoms of menopause. I’m excited we finally have research and funding to examine this area.”
What is a hot flash?
Hot flashes, also called vasomotor symptoms, are feelings of warmth that can be associated with flushing and sweating. Night sweats are hot flashes that occur during sleep. The rise in body temperature may contribute to sleep and mood issues that can negatively affect quality of life.
Hot flashes can range from mild and tolerable to severe and debilitating. Women with mild hot flashes may experience them as a sensation of heat without sweating. Severe hot flashes may cause a woman to stop activity.
Each hot flash episode typically lasts between 1 and 5 minutes and may be accompanied by sweating, chills, and anxiety. Some women can feel a rapid heartbeat at the same time. Chills can also result occur, resulting in shivering.
Source: The Menopause Society
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