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These updates are provided for general informational purposes only. They are not a substitute for professional medical advice, diagnosis, or treatment.
The U.S. FDA has approved Lynkuet (elinzanetant), Bayer’s new oral non-hormonal therapy for moderate to severe hot flashes (vasomotor symptoms) due to menopause. The approval follows its earlier authorization in the U.K. and recent approvals in Australia, Canada, and Switzerland, with additional reviews underway in other countries.
In two placebo-controlled studies involving 796 menopausal women, Lynkuet significantly reduced both the frequency and severity of hot flashes at 4 and 12 weeks. The once-daily soft gel capsule, taken at bedtime, works by targeting both the NK1 and NK3 receptors in the brain — pathways that help regulate body temperature.
According to Bayer, the U.S. launch of Lynkuet is expected in November 2025.
As with any medication, there are important safety considerations. Serious side effects may include excessive sleepiness, dizziness or fainting, liver test abnormalities, pregnancy loss, and risk of seizures in people with a seizure history. Common side effects include headache, fatigue, stomach pain, rash, diarrhea, and muscle spasms.
Lynkuet offers an additional non-hormonal option for managing hot flashes and serves as an alternative to Astellas Pharma's Veozah (fezolinetant), which targets only NK3 receptors.
This summary (posted October 27, 2025) is based on a press release by Bayer released on October 24, 2025.
New findings from researchers at Ponce Health Sciences University’s BRAVE Lab are helping explain why menopause can affect how the brain works and feels.
Brain scans show that menopause can lead to changes in brain structure, particularly in areas responsible for memory, language, and spatial skills. During this time, key brain regions — including the frontal, temporal, and hippocampal areas — may become smaller, which researchers believe could explain some common symptoms like forgetfulness or brain fog.
Interestingly, scientists also found an increase in estrogen receptors during menopause. This may be the brain’s way of adapting to lower hormone levels, though it could also play a role in temporary cognitive changes.
Changes in blood flow and energy use may further affect how efficiently the brain functions and responds to stress. The good news: early evidence suggests the brain shows signs of recovery and adaptation after menopause, offering hope that these changes may not be permanent.
This summary (posted October 22, 2025) is based on reporting from Science Daily, originally published October 21, 2025.
New research presented at the 2025 Menopause Society meeting in Orlando revealed that gastrointestinal (GI) problems could be a hidden issue for many women during menopause.
In a study of nearly 600 British women aged 44 to 73, most reported digestive issues that began or worsened during menopause. Bloating (77%) and constipation (54%) were the most common complaints, followed by stomach pain (50%) and acid reflux (49%). Over half of the women experienced symptoms frequently, and 55% said these issues affected their quality of life.
Lead researcher Nigel Denby, a registered dietitian based in London, explained, “Digestive health problems at midlife are often brushed aside, yet our research shows they are both widespread and impactful for women.”
Only one-third of participants had been diagnosed with irritable bowel syndrome (IBS), and while more than half sought medical help, most felt they didn’t receive adequate care.
Dr. Stephanie Faubion, medical director of The Menopause Society, emphasized the importance of recognizing GI problems as part of the menopause experience: “Symptoms like hot flashes, night sweats, and mood changes are more widely recognized, so it can be easy to overlook or underestimate the significance of digestive issues that may be happening at the same time.”
This summary (posted October 21, 2025) is based on reporting by Dennis Thompson for HealthDay, originally published October 21, 2025.
FDA Commissioner Dr. Martin Makary recently told CNN’s Dr. Sanjay Gupta on the Chasing Life podcast, “We are in serious discussions now about what to do about the black box warning, and I think you’ll hear something on it very soon.”
The FDA is reviewing whether to update the “black box” warning on some menopause hormone therapies — a move that could reflect new research on their benefits and risks. This review follows a July panel convened by the FDA to evaluate evidence from the Women’s Health Initiative (WHI) and discuss hormone therapy safety. Panelists urged the agency to remove the warning label.
Four major medical societies — the American College of Obstetricians and Gynecologists, the Menopause Society, the Endocrine Society, and the American Association of Clinical Endocrinology — support hormone therapy for alleviating menopausal symptoms, but do not recommend it for preventing chronic conditions like heart disease.
While it’s encouraging to see continued discussion and evolving science, experts remind us that hormone therapy isn’t one-size-fits-all. Always consult your healthcare provider and be cautious about misinformation online.
This summary (posted October 9, 2025) is based on reporting by Brenda Goodman, CNN, originally published October 3, 2025.
Cornell’s Ithaca campus and Weill Cornell Medicine are launching Menopause Health Engineering, a new initiative aimed at uncovering how menopause affects women’s health and disease risk, and at developing improved treatment strategies. Dr. Nozomi Nishimura, an associate professor in the Meinig School, founded the initiative to help build a deeper scientific understanding of menopause.
Citing longstanding bias in biomedical research and clinical trials toward male subjects, the program will focus on how menopause influences many diseases associated with aging.
This summary (posted October 1, 2025) is based on reporting by Melia Matthews in the Cornell Chronicle, originally published September 29, 2025.
A recent re-analysis of the Women’s Health Initiative (WHI) Study (27,347 women) found that menopausal hormone therapy (MHT) with estrogen (CEE) or CEE plus progesterone (MPA) reduced moderate to severe hot flashes and night sweats (vasomotor symptoms) in women aged 50–59 without significantly increasing the risk of Atherosclerotic Cardiovascular Disease (ASCVD; ASCVD includes major heart and circulation problems like heart attack, stroke, and blocked arteries).
Key Findings:
Implications:
Takeaway: Consult your healthcare providers before starting or stopping MHT.
This summary (posted September 16, 2025) is based on the research article published in JAMA Intern Med, originally published September 15, 2025
The National Menopause Foundation (NMF) and Perry announced that Governors from 12 states have issued proclamations declaring September 2025 as Perimenopause Awareness Month.
The states recognizing the importance of raising awareness are: Colorado, Georgia, Illinois, Maryland, New Mexico, North Carolina, Ohio, Oregon, South Carolina, South Dakota, Vermont, and West Virginia.
"Perimenopause can cause life-disrupting symptoms for millions of women," said Claire Gill, founder and president, NMF. "The changes that happen to women during this natural phase of life are not taught in schools or discussed during routine healthcare visits. We appreciate the state policy leaders who recognized the need to educate and support women at midlife and are helping raise awareness, so women are not suffering in silence."
At Menopause Spotlight, we support the efforts of the National Menopause Foundation and Perry to bring greater awareness to this important stage in a woman’s life.
This summary (posted September 4, 2025) is based on a PR Newswire report by the National Menopause Foundation, originally published September 2, 2025.
An article by Laura Ungar of the Associated Press reports that at a recent FDA expert panel meeting, doctors disagreed over whether hormone therapies should continue to carry the FDA’s strongest health warning, known as a “black box” warning. This warning appears in a black box at the top of the prescribing information that comes with each prescription.
According to Ungar’s reporting, the FDA-assembled panel emphasized benefits and suggested removing health warnings from at least some hormonal products. However, a letter signed by 76 doctors and researchers cautioned that “removing label warnings without adequate scientific assessment puts patients at risk,” and called on the FDA to hold a public meeting before making any changes.
Ungar also notes that doctors warn against misinformation, such as social media's claims that hormones can prevent dementia or guarantee healthy aging. Experts stress that while hormone therapy can be a great option for many menopausal women, it's important to “understand the nuanced reality of these treatments before deciding what’s best.”
This summary (posted August 28, 2025) is based on reporting by Laura Ungar, Associated Press, originally published August 23, 2025.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) is the first global regulator to approve Bayer's new drug, elinzanetant (also known as Lynkuet) for the treatment of moderate to severe hot flashes due to menopause. Lynkuet is an oral non-hormonal drug that may also help improve night sweats due to menopause.
Elinzanetant gained approval due to successful results from the OASIS clinical trials, a multinational study involving 1400+ women (40-65 years old). Daily 120 mg elinzanetant capsules significantly reduced hot flushes and night sweats in studies lasting 26–52 weeks, compared to a placebo. The drug's most common side effects include headache, fatigue, and drowsiness.
Elinzanetant is currently being reviewed by the FDA for approval in the US.
This summary (posted August 24, 2025) is based on a press release from Medicines and Healthcare products Regulatory Agency, originally published July 8, 2025.
An article on MSN highlights psychologist Dr. Kellyn Lee's insights on the key differences discusses the key differences between menopause symptoms and dementia. While both can cause memory issues, brain fog, and mood changes, menopause is temporary and driven by hormonal shifts, while dementia is progressive, irreversible, and caused by brain shrinkage and deterioration. Hormone Replacement Therapy (HRT) can ease menopausal symptoms but does not impact dementia. Menopausal symptoms typically improve over time, while dementia worsens and significantly affects daily life.
This summary (posted August 24, 2025) is based on reporting by Lauren Haughey, published on MSN News website on June 1, 2025.
A recent study from Ohio State University reveals that many U.S. women feel uncertain about menopause and what to expect. The survey, conducted in February 2025 with 1,068 participants, found that 60% of women anticipated their first menopause symptoms to appear between the ages of 41 and 50, while 25% expected symptoms to begin after age 50. However, the reality is that signs of perimenopause can show up as early as the mid-30s.
While nearly all the women surveyed (95%) recognized hot flashes as a symptom of menopause, awareness of other symptoms was much lower. Women over 60 were less likely to be familiar with other common symptoms, such as hair loss and memory issues.
Additionally, only a quarter of women identified hormone therapy as a safe and effective option for managing menopause symptoms. Younger women, aged 18 to 29, were the least likely to view hormone therapy as beneficial, favoring lifestyle approaches like diet and exercise instead.
This summary (posted August 24, 2025) is based on reporting by Roberta Burkhart, published on MedicalXpress website on May 12, 2025.
A recent AARP study found that only 21% of menopausal women aged 45 to 64 received treatment for depressive disorders, and just 20% sought help for anxiety or fear-related conditions.
This summary (posted August 24, 2025) is based on an article by Beth Carter, AARP Public Policy Institute, published on the AARP.org website April 2025.
This website provides general information to help you better understand menopause and related topics, as explored in the Menopause Spotlight books. It is not medical advice and should not replace guidance from a qualified healthcare professional. Always consult your doctor or other healthcare provider with any questions about your health, treatments, or symptoms.
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