August 6, 2023: Postpartum depression pill; bc med recall; endometrial cancer drug; MS drug safety label change; Tepezza and Ozempic lawsuits; botanical supplements study; tinnitus & eczema treatments
New Drug Approvals
The U.S. Food & Drug Administration (FDA) approved Sage Therapeutics' Zurzuvae (zuranolone) as the first oral medication to treat postpartum depression (PPD). PPD severely affects a woman's ability to return to normal functioning after giving birth. The label contains a boxed warning that the drug causes drowsiness. Patients are warned not to drive or operate heavy machinery for at least 12 hours after taking Zurzuvae. Sage's other treatment for PPD, Zulresso (brexanolone), has been available since 2019 under a restricted program called REMS that requires a certified health facility to administer the drug as continuous IV infusion given over a total of 60 hours (2.5 days).
https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression
Some mental health professionals are concerned that zuranolone will be used by everyone with PDD instead by those with severe forms of PDD. CNN interviewed women's mental health professionals for their perspectives on this new drug. Check here also for an explanation of the way this fast-acting drug works.
https://www.cnn.com/2023/08/04/health/fda-approves-first-postpartum-depression-pill-in-the-us/index.html
GSK's Jemperli (dostarlimab-gxly) / chemotherapy combination treatment was approved by the FDA for previously untreated, advanced or recurrent endometrial cancer. Since 2021, Jemperli has been approved as a monotherapy for advanced endometrial cancer that had progressed after chemo; this expanded approval will make it available to newly diagnosed patients as a "first line" treatment.
FDA Press Release
Drug Safety
Lupin Pharmaceuticals is recalling two lots of its combination oral contraceptive/folate supplement Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium) because one lot of the tablets tested low for ascorbic acid (an inactive ingredient) and high for a known impurity. The name of the impurity was not listed on the announcement. Lower levels of ascorbic acid could potentially impact the effectiveness of the product and result in unexpected pregnancy. Patients taking Tydemy are advised to continue taking their medication and immediately contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-tydemy-prescription-oral-contraceptive-may-have-reduced-effectiveness
Biogen's multiple sclerosis (MS) drug treatment Avonex (Interferon) had a drug label safety update to warn of the risk of pulmonary arterial hypertension (PAH). PAH has developed at various time points after initiating therapy with interferon beta products and may occur several years after starting treatment.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1991
Patient reviews for Avonex on Ask a Patient website
Horizon added a new warning for "severe hearing impairment" or "hearing loss" to the label for Tepezza (teprotumumab-trbw,), its drug for treating Thyroid Eye Disease (TED).
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761143s023lbl.pdf
From Opthamology Times:
https://www.ophthalmologytimes.com/view/fda-adds-hearing-loss-and-impairment-warnings-to-tepezza-label
Multiple lawsuits have been filed by patients who have experienced tinnitus after taking the drug.
https://www.drugwatch.com/news/2022/11/14/horizon-tepezza-lawsuits-hearing-loss/
One of the first lawsuits has been filed complaining of “failure to warn” about severe gastrointestinal problems linked to two GLP-1 (glucagon-like peptide-1agonist) diabetes drugs: Novo Nordisk's Ozempic and Eli Lilly's Mounjaro. Morgan & Morgan Law Firm's first case was filed by a 44-year-old woman from Louisiana who has taken both drugs at the discretion of her doctor and had severe side effects. The firm is also investigating 400 other inquiries from clients across 45 states. Ozempic and Mounjaro aren’t approved to treat obesity, but doctors can and have regularly prescribed the brands for off-label use in recent years.
https://www.cbsnews.com/news/ozempic-mounjaro-lawsuit-gastroparesis-stomach-paralysis-side-effect/
In the August 2023 issue of Worst Pills Best Pills newsletter, editors report on the substantial risks of GLP-1 drugs, including the clinical trial finding that once patients stop using GLP-1 drugs, they quickly regain lost weight.
https://www.worstpills.org/newsletters/view/1545 (this article is paywalled; abstract available)
According to a recent analysis of pharmacy claims for patients newly prescribed GLP-1 drugs for weight loss, most patients "drop out" within the year – a Prime Therapeutics analysis found that 68 percent of individuals who newly started glucagon-like peptide-1 agonist (GLP-1a) drugs for weight loss were no longer taking the drug after one year.
https://www.primetherapeutics.com/news/real-world-analysis-of-glp-1a-drugs-for-weight-loss-finds-low-adherence-and-increased-cost-in-first-year
Check out Medshadow’s report explaining common and rare side effects of Wegovy and Ozempic. Includes an easy-to-read summary infographic.
https://medshadow.org/side-effects-of-wegovy-and-ozempic/
Patient reviews of Ozempic on Ask a Patient.
Rexulti is the “add-on” antidepressant/antipsychotic drug frequently advertised on TV with this message: "If you're still experiencing depression symptoms after 2 months on an antidepressant, it may be time to talk to your doctor." It recently gained FDA approval for an entirely different indication: "to treat symptoms of agitation associated with dementia due to Alzheimer's disease.” Public Citizen’s Health Research Group urged the FDA to reject the supplemental indication and argues that the drug’s small benefits do not outweigh its substantial risks. All antipsychotics, including Otsuka's brexpiprazole (Rexulti brand name), have a black-box warning because they are associated with an increased risk of death among elderly patients with dementia.
https://www.worstpills.org/newsletters/view/1546 (article is paywalled; abstract available)
Patient reviews of Rexulti on Ask a Patient website
Drug Shortages
Mexican President Andrés Manuel López Obrador (AML) announced that he will propose that the authorities of the health sector create a "reserve bank of medicines" as a measure to combat the shortage of medicines in hospitals and care centers.
https://www.infobae.com/mexico/2023/08/02/amlo-propone-crear-banco-de-reserva-de-medicamentos-ante-desabasto/
Faced with an ongoing nationwide shortage and increased demand for stimulant prescription drugs, Robert Califf of the U.S. Food and Drug Administration (FDA) and Anne Milgram of the U.S. Drug Enforcement Administration (DEA) took the unusual action of writing a joint letter to Americans explaining that they are asking drug companies to ramp up production of the medications. While stimulants are controlled substances and the DEA sets limits on the amount that can be produced, an internal analysis suggests that manufacturers fell 30% short of the full quota in 2022, leaving about 1 billion potential doses on the table, with that trend continuing in 2023, according to the letter.
https://www.cnn.com/2023/08/01/health/adderall-shortage-fda-dea-letter/index.html
Letter: https://www.fda.gov/media/170736/download?attachment
Essential Medicines
Every two years, the World Health Organization (WHO) publishes a list of essential medicines that are selected on the basis of public health relevance, safety and efficacy, and cost-effectiveness. Countries often use the list to help choose which medicines to have on hand at all times and in sufficient amounts for their population. The recently released 23rd edition of the Model Lists of Essential Medicines (EML) includes important new medicines for the treatment of multiple sclerosis (including the off-label use of rituximab for MS), cancer, infectious diseases, and cardiovascular conditions.
For the first time, the list includes the cardiovascular "polypill," which is a combination pill containing ingredients to lower blood pressure, regulate heartbeat, lower cholesterol and may also include aspirin. Excluded from the list are GLP-1 receptor agonists (such as popular weight loss and diabetes drugs Wegovy and Ozempic), despite a request from four U.S. researchers to add them to the list.
https://www.cnn.com/2023/07/26/health/who-essential-medicines-list/index.html
Complete list: https://www.who.int/news/item/26-07-2023-who-endorses-landmark-public-health-decisions-on-essential-medicines-for-multiple-sclerosis
Drug Prices
On September 1, 2023, Medicare will target its first 10 drugs for historic price negotiations. The medications are sure to be among the country's costliest and will likely include common treatments for cancer and diabetes. The power to negotiate prices directly with drug companies is one Medicare has never before had in its 58-year history. The negotiations could save the federal government nearly $100 billion by 2031 and slash some prices Medicare pays by half. They are also the subject of multiple lawsuits by major drug makers including Merck and Johnson & Johnson. Many experts expect Eliquis, a $561-a-month drug that prevents and treats unwanted blood clots, to be among the first 10 drugs selected for negotiation.
https://www.npr.org/sections/health-shots/2023/07/28/1190324013/medicare-prescription-drug-price-negotiation
Research
Cambridge Health Alliance researchers in Somerville, Massachusetts, analyzed 57 "performance enhancing" powder sports supplements containing botanical ingredients (R vomitoria, methylliberine, turkesterone, halostachine, and octopamine) and found that only about 1 in 10 products had the "right ingredient at the right dose." Also, 12% contained FDA-prohibited substances, and 40% did not have detectable levels of the botanical ingredient touted on the label, reported lead author Pieter Cohen, MD. The study was published in JAMA Network Open.
https://www.medpagetoday.com/sportsmedicine/generalsportsmedicine/105529
University of Michigan's Kresge Hearing Research Institute researchers developed and tested a procedure that significantly alleviated the symptoms of tinnitus. The team developed a “bisensory” treatment consisting of an in-ear headphone and two externally attached electrodes that delivered a combination of acoustic and electric stimuli to reduce activity in the dorsal cochlear nucleus (DCN) in the brain stem. The level of stimulation was individualized to each person’s tinnitus. The study involved 99 people with somatic tinnitus, each of whom were given a prototype device for home treatment over the course of the study. Participants underwent the procedure for 30 minutes daily for six weeks. The study was published in Jama Network.
https://www.scientificamerican.com/article/new-tinnitus-therapy-can-quiet-torturous-ringing-in-the-ears/
Advances in Inflammatory Disorder Treatments
Heather Sullivan’s 14-year-old son, Sawyer, had struggled with eczema his entire life. When he was just a baby, most of his body would be covered in intensely itchy rashes. His family tried steroid creams, wet wraps, bleach baths, and lotions. They tore up their carpet and replaced their sheetrock in hopes of eliminating triggers. At just 15 months, he went on cyclosporine, a powerful immunosuppressant usually given to organ-transplant patients. It cleared him up, but the drug comes with potentially dangerous side effects over time and his eczema came roaring back as soon as he went off it. Recently, however, he found relief from a new monoclonal antibody treatment called Dupixent (Dupilumab). New eczema treatments are part of a broader revolution in treating inflammatory disorders. Read Sarah Zhang's "Doctors Suddenly Got Way Better at Treating Eczema" from The Atlantic.
https://www.msn.com/en-us/health/other/doctors-suddenly-got-way-better-at-treating-eczema/ar-AA1eMFTb
Patient reviews of Dupixent on Ask a Patient website.
How do monoclonal antibodies work to treat cancer? This 3 minute video from the National Cancer Institute explains how monoclonal antibodies such as trastuzumab, pembrolizumab, and rituximab block molecules cancer cells need to grow, flag cancer cells for destruction by the body’s immune system, or deliver harmful substances to cancer cells. The video is within the article:
https://cancer.gov/mab
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