Feb. 19, 2023: Safety label updates for Xarelto and Epipen; new (and unusual) constipation treatment; allergy drug withdrawal; delaying myopia in children; colon cancer and pomegranate study
Drug Safety Label Updates
The FDA (U.S. Food & Drug Administration) reported a drug safety label update for Janssen's heart drug treatment Xarelto (rivaroxaban) to add clinical trials results and risks of adverse reactions including renal disorders and respiratory disorders.
Xarelto Safety Label Change
Xarelto Patient Reviews at Ask a Patient
Mylan's Epipen and Epipen Jr. (epinephrine) autoinjection pens, used for emergency treatment of allergic reactions, had extensive safety label updates. Specific changes to the label are not indicated.
Epipen and Epipen Jr. Safety Label Change
Epipen Revised Label
New Products
People who struggle with chronic constipation have a new drug-free option to help get things moving again. The first-of-its-kind capsule is about the size of a regular pill, but instead of releasing medication after it's swallowed, it vibrates to stimulate the colon. Vibrant Gastro’s product, called Vibrant, was cleared by the US Food and Drug Administration in August but just recently became available for doctors to prescribe. Vibrant capsules are made from the same medical-grade material as pill cameras and are engineered to be durable enough to survive even accidental bites. The pills are "charged" before use in a device that connects to a cell phone.
https://www.cnn.com/2023/02/08/health/vibrating-pills-constipation-wellness/index.html
Geneoscopy announced that it submitted premarket approval application to the FDA for a noninvasive, stool-based, at-home screening test for colorectal cancer and advanced adenomas. If approved, this product will compete with the Cologuard at-home colon cancer testing product and will be an alternative to traditional colonoscopies.
https://www.geneoscopy.com/geneoscopy-submits-premarket-approval-application-to-fda-for-its-noninvasive-colorectal-cancer-rna-biomarker-screening-test/
Strange Symptom: Antihistamine causing itching after stopping
Syndicated columnist, pharmacist, and radio show host Joe Graedon writes that for years, People's Pharmacy has received comments and questions from readers who experienced "withdrawal" itching from the allergy drugs cetirizine (Zyrtec) and levocetirizine (Xyzal). Curiously, the drug labels did not list the itching (also known as "puritis") as a possible side effect. After multiple requests, the FDA eventually investigated and acknowledged the reaction in the journal Therapeutic Advances in Drug Safety (July 5, 2019). However, there is still no mention of the potential side effect on the product packaging or inserts. Joe Graedon revisits the topic in a recent column.
https://www.peoplespharmacy.com/articles/unbearable-itching-after-stopping-antihistamines-like-xyzal-or-zyrtec
Ask a Patient has more than 100 reports of itching occuring after stopping Zyrtec.
Ask a Patient reports of withdrawal itching from Xyzal
Fentanyl Linked to Pharmacies in Mexico
Mexican pharmacies just over the border from San Diego are selling some drugs that are laced with fentanyl, causing dangers for tourists who have for years frequented the pharmacy shops to buy antibiotics and other prescription drugs that are sold over-the-counter in Mexican towns like Tijuana. This has alarmed officials in California, as previously pharmacies were not connected with fentanyl-laced drugs.
https://www.latimes.com/world-nation/story/2023-02-02/mexico-pharmacy-fentanyl-laced-pills-meth
To further fuel the drug epidemic, a growing number of communities in the U.S. are dealing with the health effects caused by xylazine-laced fentanyl drugs. Xylazine is a veterinary tranquilizer which the FDA warns should never be taken by humans. While it is often added to fentanyl because it intensifies and lengthens the effects of synthetic opioids, overdoses of xylazine cannot be reversed with Narcan. Furthermore, the drug leaves users with unhealing necrotic ulcers, because xylazine restricts blood flow through skin tissue. Kaiser Health News visited Philadelphia’s Kensington neighborhood, the largest open-air drug market on the East Coast, to provide a glimpse of that community’s struggle with addiction.
https://khn.org/news/article/xylazine-animal-tranquilizer-fentanyl-opioids-kensington-philadelphia-health-problems/
Drugs and Treatments Research
A study by researchers at Chinese University of Hong Kong and Hong Kong Eye Hospital found that eye drops commonly used to dilate eyes before an eye exam can also be used to stave off myopia (near sightedness) in children. In the study, nightly use of 0.05% atropine eye drops in children age 4 to 9 without myopia but considered to be at-risk for developing it, led to a significantly lower incidence of myopia after 2 years, and it also slowed the progression of the myopia. The participants are currently in their third year of follow-up, and the total intended follow-up duration is 6 years to evaluate whether effects represent only a delay or actual prevention of myopia onset. In the U.S., approximately one-third of the population is myopic, and this is expected to increase to almost 60% by 2050. The study was published in JAMA.
https://www.medpagetoday.com/pediatrics/generalpediatrics/103097
Some studies have shown that children who wear multifocal contact lenses have slower progression of their myopia, or nearsightedness, over three years. The findings support using multifocal contacts to treat myopia in children, which could help prevent other vision problems later in life.
https://www.nih.gov/news-events/nih-research-matters/multifocal-contact-lenses-slow-myopia-progression-children
Research & development costs don't justify rising drug prices, according to an analysis done by researchers at the London School of Hygiene and Tropical Medicine. Based on publicly available financial reports from 1999 to 2018, the 15 largest biopharmaceutical companies had total revenues of $7.7 trillion. Over this period, the companies spent $2.2 trillion on costs relating to selling, general, and administrative activities—a category that includes marketing and advertising, as well as almost all other business costs not directly attributable to manufacturing a product or performing a service—and $1.4 trillion on R&D. The authors argue that by refocusing their spending, drug companies could provide more innovative drugs at affordable prices. The study was published in the BMJ.
Many studies have come out in recent years about the therapeutic effects of the pomegranate fruit (as well as berries) on the immune system. A recent study by Frankfurt Cancer Institute at Goethe University found that Urolithin A, a metabolite product from pomegranate, substantially boosted immune cell response in mice with colorectal cancer. The research was published in Cell's Immunity.
https://www.sciencedaily.com/releases/2022/10/221026122728.htm
Pomegranate food tip: Getting to the tasty and nutritious seeds can be tricky. Voraciously food writer Becky Crystal researched different methods, and found this to be the best method to get to the seeds: "Cut the pomegranate in half through the equator, hold a half cut side down in your hand over a dish or bowl and whack it — firmly, confidently — with a wooden spoon using the underside of the bowl of the spoon. It took me a less than two minutes per half to remove all the seeds, no prying required."
https://www.msn.com/en-us/foodanddrink/recipes/the-best-way-to-de-seed-a-pomegranate-is-also-the-most-therapeutic/ar-AA16TUj
Reminder to readers: Starting this year (2023), Ask a Patient® Health News is divided into two newsletters: Drugs & Treatments (this newsletter) and General Health News. The general edition covers disease, diagnosis, international health-related news, patient privacy, consumer advocacy, health policy, health insurance, and food recalls. When you sign up on our web site, you will be subscribed to both newsletters, but may unsubscribe to either one. Due to the President's Day holiday, this week's General Health News will be sent on Tuesday, February 21.
Make sure to check your Tuesday email for news about medical relief efforts for earthquake victims in Turkey and Syria, health concerns related to the chemical spill/fire in Ohio, imaging disparities for Medicare patients with non-small cell lung cancer, rise in hospital-acquired sepsis cases, surge in PBM (Pharmacy Benefit Manager) revenues, a large hospital data breach, and a Duke University study exposing how data brokers are selling your personal health information.
Visit us as AskaPatient.com for drug reviews provided by patients along with more news and health information.