May 14, 2023: New treatment for hot flashes; OTC oral contraceptive; health apps privacy; preventing hypothyroidism; metformin for longer life; cancer and immunotherapy
"Vasomotor symptoms" Treatment Approved
The U.S. Food & Drug Administration (FDA) approved Astellas Pharma's Veozah (fezolinetant), a non-hormonal oral 45 mg. tablet to be taken daily for the treatment of moderate to severe hot flashes ("vasomotor symptoms") caused by menopause. Veozah is a "neurokinin 3 (NK3) receptor antagonist" that works by blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature. Because the drug may cause elevated liver enzymes or liver injury, patients are required to have a blood test in advance of starting the medication and every three months for the first nine months while using it. It also should not be taken by patients with kidney disease. The most common side effects of Veozah include abdominal pain, diarrhea, insomnia, back pain, elevated liver enzymes, and surprisingly, "hot flashes." The cost will be $550 for a 30 day supply but cost from insurance or with rebates will be less for patients.
https://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause
Astellas’ fezolinetant has also been accepted for review by the European Union Medicines Agency (EMA), and by regulatory agencies in Australia and Switzerland.
https://www.labiotech.eu/trends-news/astellas-fezolinetant-accepted-for-regulatory-review-by-ema/
Astellas is launching an aggressive awareness campaign for "VMS" (vasomotor symptoms) in order to market its drug to the potential 21 million women in the U.S. it estimates will have menopause symptoms by 2025. According to the marketing campaign, "your internal infernos” may “impact many aspects of your life including your sleep, ability to focus, and personal relationships." Health writer Martha Rosenberg laments this revival of "menopause as a disease" and how drug development priorities seem to only follow the money.
https://www.kevinmd.com/2023/03/fool-women-twice-drug-makers-revive-menopause-as-a-disease.html
"Medicalization of menopause" is controversial; hormone replacement therapy (HRT) was the standard of care for menopausal women until 2002, following release of the initial results from the Women's Health Initiative (WHI) trial, which showed a link between HRT and breast cancer. British Medical Journal editors and other experts are calling for a new narrative for menopause, which is a natural stage of a woman's life. They say that "medicalization of menopause makes women fearful and reduces their ability to cope with it as a normal event."
https://www.cnn.com/2022/06/17/health/menopause-medicalization-women-ageing-bmj-as-equals-intl-cmd/index.html
More FDA Approvals and Safety Updates
The FDA approved expanded use of Vertex's cystic fibrosis (CF) drug Trikafta to include children 2 years of age and older. The drug was initially approved in October 2019 for patients 12 years of age and up. Dosage depends on age and weight. CF is a rare and serious genetic disorder that results in the formation of thick mucus that builds up in the lungs and other parts of the body, leading to severe breathing problems.
https://www.medpagetoday.com/pulmonology/cysticfibrosis/104230
FDA label update
Migraine headache/seizure drug Topamax (topiramate) had a drug safety labeling change to warn of potential interactions with oral contraceptives including progestin-only versions.
Topamax safety labeling change
Topamax reviews on Ask a Patient
Oral Contraceptive “Opill” Closer to OTC Approval
Two FDA advisory panels unanimously recommended that the FDA approve Perrigo's Opill (norgestrel) progestin-only oral contraceptive for over-the-counter purchase. In many Asian, African, and South American countries the pill is available without a prescription or with only a pharmacist consultation, but in European countries (except U.K.) Australia, Japan, and others, a prescription is required. The FDA will make its decision in the coming months.
https://www.upi.com/Top_News/US/2023/05/10/fda-advisers-approve-opill-without-prescription/2211683746594/
What do you think? Should the FDA approve Opill for over-the-counter availability, and if so should there be any caveats, such as a requirment for a pharmacist consultation?
Drug Research
Ketamine is useful for treating depression but it can cause dissociative symptoms—such as having an out-of-body experience or feeling emotionally numb. A team led by investigators at Massachusetts General Hospital (MGH) studied epilepsy patients to discover how ketamine influences different circuits in the brain to produce its antidepressant and dissociative effects. The research was published in Nature Communications.
https://www.massgeneral.org/news/press-release/ketmaine-depression-dissociative-effects
Metformin and Aging Study
Dr. Nir Barzilai, Director of the Einstein Institute for Aging Research in New York suggests that one of the cheapest diabetes drugs on the market, metformin, can also slow aging and extend your life span. Metformin is derived from Galega officinalis, also known as goat’s rue, a traditional herbal medicine in Europe, which had been used for centuries to treat numerous ailments, including digestive health and diabetes-like issues. Researchers think metformin acts on several different hallmarks of aging—changes at the cellular, chromosomal and molecular levels which accumulate over time. Barzilai is finalizing funding for the Targeting Aging with Metformin (TAME) clinical trial, which will track 3,000 adults 65 to 80, who will take metformin for six years.
https://fortune.com/well/2023/05/04/metformin-anti-aging-longevity-risks-side-effects/
Check out patient reviews for metformin (Glucophage brand name) on Ask a Patient.
Extended release Glucophage reviews on Ask a Patient.
Researchers at Saint James School of Medicine compared phamaceutical (levothyroxine) and lifestyle modification treatments for reducing TSH levels in women with "Subclinical hypothyroidism" (SCH). Those with SCH have elevated levels of TSH but the levels are not high enough to be classified as hypothyroidism. It is standard practice for SCH women who are pregnant or planning to conceive to take levothyroxine. For others, a three to six month trial of levothyroxine with follow-up monitoring is considered reasonable. Lifestyle interventions, such as adding iodine to the diet, often result in significant reduction of symptoms. The study was published in Cureus.
https://www.cureus.com/articles/152397-comparison-between-levothyroxine-and-lifestyle-intervention-on-subclinical-hypothyroidism-in-women-a-review#!/
Patient reviews of levothyroxine
Patient reviews of Synthroid (levothyroxine)
Patient reviews of Cytomel (levothyroxine)
List of Thyroid medications with links to reviews, including the natural (not synthetic) alternative treatment Armour Thyroid.
Researchers at Schmidt College of Medicine conducted a comparison review of the efficacy and safety of ustekinumab and adalimumab for the treatment of moderate to severe Chron's disease. They found that both drugs have similar effectiveness in achieving clinical remission, clinical response, radiological remission and steroid-free remission. Therefore, the choice of treatment between the two drugs may depend on other factors such as patient preference, cost, and previous treatment history. The study was published in Cureus.
https://www.cureus.com/articles/153052-comparison-of-effectiveness-and-safety-of-ustekinumab-and-adalimumab-as-induction-or-maintenance-therapy-in-patients-with-moderate-to-severe-crohns-disease-a-systematic-review-and-meta-analysis#!/
“Privacy Not Included” in Many Mental Health Apps
Researchers at Mozilla examined 32 mental health therapy apps and found that many of them are still collecting large amounts of personal data under questionable or deceptive privacy policies. This was a follow-up study to last years' "Privacy Not Included" review in which 28 out of 32 apps were slapped with a "Privacy not included" warning in Mozilla's guide.
https://www.theverge.com/2023/5/4/23710840/mental-health-therapy-apps-mozilla-report-privacy-data-security
Mozilla’s Privacy Guide 2023
Cancer Immunotherapy Treatments Potential
When the first immune checkpoint inhibitor – which works by blocking checkpoint proteins to help the body recognize and attack cancer cells – ipilimumab, was approved in 2011, it marked a major breakthrough in cancer immunotherapy. Other cancer immunotherapy treatments include cancer vaccines and cell therapies. Immune checkpoint inhibitors and vaccines are mainly approved in the treatment of solid tumors, whereas cell therapies – although also being explored for solid malignancies – have proven to be very effective for treating blood cancers. Labiotech provides an overview of five types of cancer that can be treated with immunotherapy.
https://www.labiotech.eu/best-biotech/cancers-immunotherapy-cure/
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