July 28, 2024: New drug approvals; overseas facilities warned; cinnamon recalls; hearing loss from cancer treatment; safest spices, more
New FDA Drug Approvals
Dissolving Birth Control Pill
The U.S. Food & Drug Administration (FDA) approved Millicent's Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating birth control pill. Because it dissolves in the mouth, this new formulation will help patients who have difficulty swallowing.
FDA approval document
https://www.patientcareonline.com/view/fda-approves-femlyv-first-orally-disintegrating-tablet-for-birth-control
Peanut Allergy Drug Use Expanded to Younger Children
The FDA expanded the approval of Aimmune Therapeutics’ Palforzia (Peanut Allergen Powder) to include patients age 1 to 3 with diagnosed peanut allergies to help reduce allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. Palforzia was first approved in January 2020 for use by patients age 4 to 17. Those who take Palforzia must continue to avoid peanuts in their diets. A Risk Evaluation and Mitigation Strategy (REMS) is in place for Palforzia to mitigate the risk of anaphylaxis associated with Palforzia.
Reported in the FDA News roundup
Breast Cancer Drug Approved for Use with Fulvestrant
Novartis' Kisqali (ribociclib) received expanded approval to treat adults with HER-2 negative advanced breast cancer in combination with fulvestrant (Faslodex brand name) for initial or ongoing endocrine-based therapy (estrogen-blocking). Kisqali tablets were first approved in 2017 for treating breast cancer in conjunction with an aromatase inhibitor letrozole (Femara brand name). Letrozole is also an estrogen blocking therapy.
FDA approval document
Patient reviews for Faslodex (fulvestrant)
Patient reviews for Femara (letrozole)
More on Kisqali:
It's relatively unusual for the FDA's Office of Prescription Drug Promotion to send out a warning, especially to a major pharmaceutical company, but Novartis received a “untitled” letter about a Kisqali television advertisement called "Long Live" that aired in late 2022. The FDA warned Novartis that the commercial made false claims about the drug's ability to "preserve their quality of life."
https://www.fiercepharma.com/marketing/fda-chides-novartis-false-or-misleading-kisqali-tv-spot-dissecting-ad-claims-untitled
Screen shots from the TV commercial: https://www.fda.gov/media/175585/download?attachment
Note: we're still waiting for prescription drug TV ads to abide by the new regulations that require inclusion of risk messages that are easy-to-read and without distractions. Having seen none so far, it seems that sponsors may be waiting until closer to when the "grace" period ends in November 2024. Possibly, there could be a plan in the works to overturn or at least delay the implementation of the regulation before the deadline.
Overseas Drug Facilities Receive Inspection Warnings
The FDA published the warning it sent to Brassica Pharma for numerous good manufacturing practice (GMP) violations, including multiple instances of employees falsifying sterility and environmental monitoring data and lax controls to prevent microbiological contamination. The violations were found at the company’s Maharashtra, India facility after a four-day inspection in January 2024 and were not posted to FDA’s website until July 23. Following the inspection in January, the company recalled several of its sterile eye ointments. The FDA also placed the company on an import alert on 30 January 2024. Until improvements are made at the facility, its products will not be allowed into the U.S.
https://www.fiercepharma.com/pharma/fda-blasts-indian-cdmo-brassica-routine-data-falsification-poor-hygiene-and-more
Warning letter to Brassica from FDA
We reported on the Brassica recalls in March. The products included Target’s Equate eye ointment and many other store brand names. Read about the recall here:
The FDA posted the warning letter it sent to Vietnamese over-the-counter drug maker Yahon Enterprise for various product testing failures, including releasing drugs without adequate quality control testing, failing to perform identity testing for ingredients such as ethyl alcohol and benzylkonium chloride used to manufacture OTC drugs, and failure to adequately establish expiration dates.
Survey Suggests Medical Marijuana Reduces Other Rx Use
More than 3 of 4 New York State medical marijuana patients say cannabis has allowed them to reduce their intake of prescription drugs, according to a new report from the state’s Office of Cannabis Management (OCM). That includes 2 of 3 who report that marijuana has “reduced their need for prescription opioids for pain reduction.” Past and current medical marijuana patients, along with medical providers recommending the treatment were included in the survey.
https://www.marijuanamoment.net/most-new-york-medical-marijuana-patients-say-cannabis-has-reduced-their-use-of-prescription-opioids-and-other-drugs/
Research on Cancer Drug Cisplatin and Hearing Loss
In 2018, National Institutes of Health (NIH) researchers found that, in both mice and humans, cancer drug cisplatin can be found in the cochlea (the part of the inner ear that enables hearing) months and even years after treatment. By contrast, the drug is eliminated from most organs in the body within days to weeks after being administered.
The University of South Florida and Indiana University researchers recently discovered that significant hearing loss can occur from long-term effects on hearing (ototoxicity) from cisplatin, one of the most common forms of chemotherapy.
https://www.usf.edu/news/2024/chemo-drug-may-cause-significant-hearing-loss-in-longtime-cancer-survivors.aspx
Have you ever taken cisplatin? Please add your rating at Ask a Patient.
Inner ear macrophages (cochlear macrophages) are immune cells that play a crucial role in maintaining the homeostasis and hearing function of the inner ear. Researchers from the National Institutes of Health (NIH), testing their technique in mice, discovered that by "ablating" or discontinuing ear macrophage function temporarily using the test drug PLX3397, ear hair cells may be less likely to die and so hearing can be preserved after cisplatin treatment. The study was published in Science Advances.
https://www.science.org/doi/10.1126/sciadv.adk9878
Diagnosing Sepsis Research
Scientists from Seoul National University in South Korea have developed a faster way to diagnose and treat sepsis. A new ultra-rapid, phenotype-based antimicrobial susceptibility testing (AST) method eliminates the need for conventional blood culture in patients with suspected sepsis. This potentially speeds up the initiation of treatment with antibiotics by 40 to 60 hours. The study appeared in Nature.
https://www.cidrap.umn.edu/sepsis/scientists-say-they-developed-faster-way-diagnose-treat-sepsis
Cinnamon Recalls, Lead in Spices, and Cinnamon Health Benefits
The FDA announced an additional cinnamon product recall due to the presence of lead, bringing the total recalled products in the category to seven. The new product added on July 25 is El Servidor Corp’s “canela molida” (ground cinnamon), pictured below. Please check the FDA website for the complete list.
FDA Announcement on cinnamon recall
Spices Safety
Consumer Reports tested common dried spices for arsenic, cadmium, and lead (not including baking spices like cinnamon) and found that certain categories of spices tended to be safer than others. For example, they found safe results across-the-board for: black pepper, white pepper, saffron, sesame seed, garlic powder, curry powder, and coriander. Those spices that tested as riskiest (all or half of the samples had unacceptable levels of lead or other contaminants) included cumin, basil, thyme, ginger, oregano, paprika, and turmeric. Check out the full report here, which lists brand names and scores for the spices.
https://www.consumerreports.org/health/food-safety/your-herbs-and-spices-might-contain-arsenic-cadmium-and-lead-a6246621494/
Cinnamon as a Health Supplement
Cinnamon, which is sourced from the bark of several types of cinnamon trees, is sometimes used as a dietary supplement to address health concerns like inflammation, gastrointestinal problems, blood pressure, diabetes, heart disease, and even cancer. The Checkup describes the different kinds of cinnamon, how it may be used as a health supplement, and what you need to know about its safety. Tip: the powdered cinnamon used for baking found at your local grocery store (while delicious) is most likely not Ceylon or Mexican cinnamon, which is considered the best for supplementation and is very expensive.
https://www.singlecare.com/blog/health-benefits-of-cinnamon/
Note to readers: Watching the Olympics? Look out for our special post on Tuesday! "Summer Olympics 2024: Drugs allowed and banned (and more)"
A look at what drugs athletes can and can't take, the drug doping debacle, what happens if an athlete catches Covid, and mental health support for athletes.
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