February 5, 2023: New breast cancer, lymphoma, diabetes meds; artificial tears and cough syrup products safety; FTC goes after GoodRx for misusing patient data; new discount drug programs
FDA Drug Approvals
- Stemline Therapeutics' Orserdu (elacestrant) pill was approved by the FDA as an oral treatment for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated metastatic breast cancer with disease progression following at least one line of endocrine therapy. The drug is an estrogen receptor antagonist. This article includes an 8 minute podcast featuring an interview with Dr. Virginia Kaklamani, who explains how the drug works and results from the EMERALD clinical trial study.
https://www.breastcancer.org/research-news/orserdu-fda-approval
- Eli Lilly's Jaypirca (pirtobrutinib) tablet, a kinase inhibitor, was approved by the FDA for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. The product received priority review, orphan drug status, and fast track designation. Continued approval may be contingent on verification and description of clinical benefit in a confirmatory clinical trial.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pirtobrutinib-relapsed-or-refractory-mantle-cell-lymphoma
- TheracosBio's Brenzavy (Bexaglifozin) was approved by the FDA to treat adults with type 2 diabetes as an adjunct to diet and exercise. Brenzavy joins the class of SGLT2 inhibitors, which includes AstraZeneca's Farxiga, Eli Lilly’s Jardiance, and Johnson & Johnson’s Invokana. Brenzavy’s label includes warnings for ketoacidosis, a complication in which the blood becomes acidic. Notably, TheracosBio's Oexagliflozin product was approved by the FDA in December 2022 as the first oral treatment for cats with diabetes mellitus.
https://medcitynews.com/2023/01/theracosbio-drug-approval-puts-it-in-competition-with-blockbuster-diabetes-meds/
- The U.S. Food and Drug Administration (FDA) approved Glaxo Smithkline's Jesduvroq (daprodustat) tablets as the first oral treatment for anemia caused by chronic kidney disease for adults who have been receiving dialysis for at least four months. Jesduvroq is not approved for patients who are not on dialysis. Jesduvroq has a boxed warning for an increased risk of blood clotting events including death, heart attack, stroke, and blood clots in the lungs, legs, or dialysis access site.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-anemia-caused-chronic-kidney-disease-adults-dialysis
Drug Safety
- Drug safety label updates were issued for the oral contraceptives Seasonique, Seasonale, Loseasonique (levonorgestrel and ethinyl estradiol) to add new contraindications for those with breast cancer or over the age of 35 with diabetes. Other label changes relate to age-related considerations, thromboembolic disorders, and more.
Seasonique revised drug label
Loseasonique revised drug label
Seasonale label change
- EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears are under a product recall due to potential bacterial contamination with a drug-resistant strain of Pseudomonas aeruginosa. The "dry eye" treatments were manufactured in India by Global Pharma Healthcare Private Limited and have been sold at Amazon and Walmart over-the-counter and also used by hospitals. The FDA has blocked imports from the company because of manufacturing violations, including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging.
As of January 31, 2023, 55 patients in 12 states have been sickened by contaminated products, resulting in one hospitalization, one death with bloodstream infection, and five cases of permanent vision loss. The bacteria in the outbreak infected patients in different parts of the body, ranging from respiratory infections to the urinary tract. Only one antibiotic – cefiderocol appears to work against this bacteria strain.
https://www.yahoo.com/now/fda-faults-company-behind-recalled-030147379.html
FDA press release and product photos.
- The U.S. FDA is joining the World Health Organization (WHO) in the investigation of the source of contaminated cough syrups that have killed more than 300 children, most under the age of 5, in Gambia, Indonesia and Uzbekistan and at least four other countries. The tainted products, which the FDA says have not been distributed in the U.S., are connected to an Indian pharmaceutical firm and contain ethylene glycol and diethyelene glycol, found in some syrup-based paracetamol (acetametaphin) medications. These two toxic ingredients are used in antifreeze, brake fluids and other industrial applications, but also are used as a cheaper and illegal alternative in some pharmaceutical products to glycerine, as a solvent or thickening agent. This can lead to acute kidney injury. In 2006, cough syrup containing ethylene glycol was implicated in deaths of children in Panama.
https://www.cbsnews.com/news/fda-international-investigation-contaminated-cough-syrups-killed-over-300-children/
- According to Center for Infectious Disease Research & Policy at the University of Minnesota, U.S. regulators have stepped up their foreign inspections after a pandemic pause, unleashing a slew of warning letters on serious manufacturing missteps. "Unsafe drugs are just the tip of the iceberg," Dinesh Thakur, MS, former pharmaceutical executive and coauthor of the recently published book The Truth Pill: The Myth of Drug Regulation in India. "Substandard or ineffective drugs may be an even bigger problem."
https://www.cidrap.umn.edu/resilient-drug-supply/tainted-drug-deaths-weak-regulation-corrode-confidence-indian-drugs
FTC Sues GoodRx for Consumer Data Privacy Violations
- The U.S. Federal Trade Commission (FTC) has taken action against drug coupon company GoodRx for sharing sensitive personal information on millions of users with companies like Facebook and Google without authorization. Personal data included prescription medications, illnesses and site searches, which were then linked, when possible, to Facebook profiles. GoodRx also targeted users who had looked up information on HeyDoctor, the company's telemedicine service, the complaint said. Also, the data disclosures broke public promises the company had made to "never provide advertisers any information that reveals a personal health condition."
It is the first enforcement action the FTC has taken under its Health Breach Notification Rule, which requires vendors of personal health records and related entities to notify consumers and the FTC when that data is disclosed or acquired without the consumers’ authorization. While GoodRx agreed to settle the case for $1.5 million, it said it disagreed with the agency's allegations and admitted no wrongdoing.
https://themarkup.org/pixel-hunt/2023/02/01/the-ftc-is-taking-on-telehealths-data-sharing-problem-starting-with-goodrx
In 2020, Consumer Reports called out GoodRx for their practices and GoodRx removed Facebook tracking pixels from its web site.
New Pharmacy Services
- Amazon launched a discount pharmacy service, RxPass, as an add-on for its Prime members. It covers generic drugs for more than 80 common chronic conditions for a flat fee of $5 per month, delivery included. The service does not include insulin, and cannot be used with Medicare or Medicaid. It is accepted in most, but not all states. According to the terms of the program, only one RxPass account per Prime membership is allowed. However, you can change the individual on your Prime account that is enrolled in the RxPass program. Amazon launched its online pharmacy, which has a larger selection of drugs available, in December 2020.
https://www.forbes.com/sites/saibala/2023/01/28/amazons-bold-5-prescription-drug-program-is-the-future-of-pharmacy/
- OptumRx, UnitedHealth Group’s pharmacy service, launched Price Edge, a tool for members that compares available direct-to-consumer pricing for generic drugs with insurance pricing. If there is a lower cost to the member outside of their insurance benefit, Price Edge automatically applies that price. This is different than other "cash only" discount programs, because the payments count towards deductibles and out-of-pocket maximums.
https://www.healthcarefinancenews.com/news/optum-rx-launches-price-edge-offer-lower-prices-generics
Food as Medicine
- Sometimes, diet can be the best medicine. Listen (or read the transcript) of a Medical News Today podcast about why and how diet might help fight symptoms of depression. Learn about the "golden rules" of what to cook in order to maintain your mental wellbeing. Guests include Dr. Najaf Amin and mental health advocate Rachel Kelly. 33 minute podcast.
https://www.medicalnewstoday.com/articles/in-conversation-can-diet-help-improve-depression-symptoms
Treatments Research
- Among postmenopausal women with vulvovaginal atrophy, ospemifene (Osphena brand name) treatment and hormone therapy improved the vaginal microbiome in different ways, according to findings of IRCCS Azienda Ospedaliero Universitaria di Bologna in Italy, published in Menopause.
https://www.healio.com/news/womens-health-ob-gyn/20230130/ospemifene-hormone-therapy-may-improve-postmenopausal-vulvovaginal-atrophy
Osphena patient reviews
- High-intensity aerobic exercise may decrease the risk for cancer metastasis by 72%, according to a study conducted Tel Aviv University’s Sackler School of Medicine. Researchers found that high-intensity exercise causes internal organs to absorb more glucose, thereby decreasing the energy available to the tumor. The findings were published in Cancer Research.
https://www.healio.com/news/hematology-oncology/20230130/highintensity-aerobic-exercise-may-greatly-reduce-risk-for-metastatic-cancer
Medication Tip
Did you know that if you had a penicillin allergy as a child, there's an 80% chance that you no longer have the allergy? Check out Mayo Clinic's list of five common misperceptions about penicillin allergies.
https://www.mayoclinic.org/medical-professionals/pediatrics/news/5-common-misperceptions-about-penicillin-allergies/mqc-20440491
Visit us at www.askapatient.com for more on medications.
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