October 15, 2023: New drugs for lung cancer, ulcerative colitis; Prilosec-Nexium settlement; nitrosamine drug recall update; IBS podcast; calming your anxiety; questions about meds to ask your doctor
New Drug Approvals
The U.S. Food and Drug Administration (FDA) approved Array BioPharma's Braftovi (encorafenib) and Mektovi (binimetinib) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. Encorafenib plus binimetinib is also approved to treat advanced melanoma and colorectal cancer. The drugs are meant to be used only after taking a companion diagnostic test (plasma or tumor) to detect the mutation. If no mutation is detected in a plasma specimen, then tumor tissue should be tested. Array BioPharma is a wholly owned subsidiary of Pfizer.
https://www.medpagetoday.com/hematologyoncology/lungcancer/106762
FDA press release
The FDA approved Pfizer's Velsipity (etrasimod) once-daily tablets as treatment for moderately to severely active ulcerative colitis in adults. Common adverse reactions are headaches, elevated liver tests and dizziness. Serious side effects may include infections and a slow heart rate.
https://www.medpagetoday.com/gastroenterology/inflammatoryboweldisease/106782
Novartis' plaque psoriasis drug Cosentyx (secukinumab) was approved as an intravenous (IV) formulation. It is the first new intravenous (IV) treatment option in six years for adults with psoriatic arthritis (PsA),ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. Previously, it only had a subcutaneous (using a short needle that goes under the skin) formulation.
https://www.novartis.com/us-en/news/media-releases/fda-approves-novartis-cosentyx-first-intravenous-iv-formulation-interleukin-17a-antagonist-rheumatic-diseases
Patient reviews of Cosentyx on Ask a Patient
Medical Lawsuits
AstraZeneca will pay $425 million to settle lawsuits alleging that patients suffered kidney injuries while using the heartburn drugs esomeprazole (Nexium) or omeprazole (Prilosec).
https://www.forbes.com/sites/maryroeloffs/2023/10/03/astrazeneca-settles-lawsuits-alleging-heartburn-drugs-caused-kidney-disease-for-425-million/?sh=231fd093767e
Ron Irby expected the artificial knee implanted in his right leg in September 2018 would last at least two decades. Yet in just three years, the Optetrak implant manufactured by Exactech in Gainesville, Florida, had worn out and had to be replaced — a painful and debilitating operation. He is among the more than 1,100 patients suing Exactech after it began recalling artificial knees, hips, and ankles, starting in August 2021. Kaiser Health News reports that court documents and other government records show that the company is being accused of downplaying or concealing evidence of product failures from patients and federal regulators for years. A whistleblower lawsuit is also pending.
https://kffhealthnews.org/news/article/exactech-hip-knee-replacement-implant-lawsuit/
Nitrosamine-Related Drug Recalls of 2018-2020: Where are those drugs now?
Starting back in July 2018, drug regulators worldwide began to recall certain blood pressure drugs containing valsartan (an Angiotensin II Receptor Blocker, or ARB) because of traces of nitrosamine detected at levels thought to be potentially carcinogenic (cancer causing) to humans. Over the next few years, additional generic and brand name drugs with nitrosamine impurities linked to manufacturing facilities in China and India were recalled. Here is a list of those drugs, along with current availability status.
ARBS (“sartan” blood pressure drugs): Generic ARBs affected by recalls included valsartan, losartan and irbesartan. Brand name Diovan (valsartan) was never affected by the recall. However, so many drugs were on the recall list that the FDA had to publish a separate list of drugs NOT being recalled. Today, because there are multiple producers of the drugs, all three are still available but are occasionally in short supply. For example, Irbesartan tablets are currently in shortage, as are some losartan/hydrochlorothiazide tablets, according to the ASHP Drug Shortages database.
List of ARBs with links to patient reviews on Ask a Patient website
CHANTIX: Used to quit smoking, Chantix (varenicline) was recalled in 2021 for suspected presence of nitrosamine, and has still not resumed production but the pills are available as a generic. "The Checkup" presents post-recall information on the smoking cessation drug Chantix and its alternative.
https://www.singlecare.com/blog/news/chantix-recall/
Patient reviews of Chantix (varenicline) on Ask a Patient website
RANITIDINE: Recalls of stomach acid blocker Zantac (ranitidine) began in April 2020. Ranitidine is no longer available as a generic or brand name, but Zantac has been re-branded as "Zantac 360" with a new formulation. Instead of ranitidine, it contains another “H2 blocker” famotidine. Famotidine was originally sold under the brand name Pepcid and is now also available OTC as Pepcid AC and as generic. There is no nitrosamine problem with famotidine.
Check out Ask a Patient’s “How to Choose a Heartburn Treatment at the Drug Store.”
https://www.askapatient.com/news/otc-heartburn-stomach-acid-treatments.asp
METFORMIN: Beginning in 2020, some recalls began for extended release (ER) versions of the diabetes drug metformin. In total, 281 products have been recalled. There are multiple producers of the drug and metformin ER is still available today.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin
Not recalled, but investigated: RIFAMPIN: This antibacterial used to treat tuberculosis and other bacterial infections was investigated for nitrosamine contamination beginning in August 2020, but a recall did not take place. However, in April 2023, due to Akorn (generic maker) going bankrupt, a recall was placed for three of its rifampin capsules. The product (along with rifapentine) is still available from other generic manufacturers.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-nitrosamines-rifampin-and-rifapentine
The FDA provides an information page about nitrosamine impurities in medications, including an explanation of actions taken since 2018 to help ensure drug quality. The FDA also describes the “acceptable limits" for the nitrosamine impurities.
https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications
In India, a recent government mandate instructs doctors to only prescribe generic drugs. The India Medical Association (IMA) is asking for deferment of the rule, expressing concern for patient care and safety. The IMA says only .1% of drugs produced in India are quality tested.
https://health.economictimes.indiatimes.com/news/policy/rule-mandating-doctors-to-prescribe-generics-may-hit-patient-safety-ima/102732744
Medication and Treatment Tips
In order to find out about potential benefits and risks of drug treatments before you start taking them, spend a little time preparing for your doctor's visit by making a list of the drugs, supplements, and vitamins you’re presently taking. Also, come prepared with questions to ask about drugs that you may be prescribed. Check out MedShadow Foundation's "Questions You HAVE to Ask Your Doctor: What You Want to Know Before Taking a Medicine." The article also includes specific questions applicable to the following treatment categories: antidepressants/antianxiety,sleep aids, GERD (acid reflux) drugs, and ADHD drugs.
https://medshadow.org/questions-to-ask-your-doctor/
Do you have Irritable Bowel Syndrome (IBS)? In this "Gut Talk" podcast episode, Kate Scarlata, MPH, RDN, chats with hosts William D. Chey, MD, AGAF, FACG and Sameer K. Berry, MD about how patients with IBS can manage a low-FODMAP or other special diet without causing undue stress. She advises that patients should avoid over-restricting their diets and warns that digital therapeutic tools (such as the MONASH app) might cause users to become overly-compulsive with self-monitoring. She discusses how low-FODMAP diet can be achieved without having to go on a full-blown elimination diet. Scarlata is the author of an upcoming book, Mind Your Gut: The Whole-body, Science-based Guide to Living with IBS. Episode length is 45 mintes.
https://www.healio.com/news/gastroenterology/resources/gut-talk/episode-25
Whether you’re experiencing a panic attack or feeling other symptoms of anxiety, it is possible to intervene on your own behalf. “While regaining control of your breathing during an anxiety attack can be tricky, it is crucial for managing the symptoms and calming your body and mind,” said Deepti Agarwal, MD, director of interventional and integrative pain management at Case Integrative Health in Chicago. Health writer Leandra Beabout presents ten different breathing exercises you can try, from "Simple structured breathing" to "Kapalbhati breathing."
https://www.singlecare.com/blog/breathing-exercises-for-anxiety/
Thank you for reading this issue. Visit us as AskaPatient.com for drug ratings and reviews provided by patients along with more news and health information.
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I do not want any of these bogus drugs from big pharma making it worse, and as a plus increasing side effects which they will happily (💰) give me more drugs for.