April 21, 2024: Better breast cancer surgery; research on beta blockers after heart attack; drug-induced restless legs syndrome; injectable progesterone; avoiding pesticides in food; vitamins tips
FDA New Approvals
The U.S. Food and Drug Administration (FDA) approved Lumicell’s Lumisight (pegulicianine), an injected fluorescent imaging agent, for use during breast cancer surgery (lumpectomy) to aid in detection of residual cancerous tissue. This agent, along with the Lumicell Direct Visualization System (DVS) or another fluorescence imaging device, will help ensure a more thorough removal of the tumor. Lumisight is administered via intravenous injection before surgery, and glows when it encounters cancer cells. Lumicell said its system can provide 84% diagnostic accuracy.
https://otc.duke.edu/news/lumicells-cutting-edge-imaging-platform-receives-historic-fda-approval-to-illuminate-residual-breast-cancer/
The FDA approved a subcutaneous formulation of Takeda’s Chron’s disease drug Entyvio. Previously, it had only been available by I.V. infusion.
https://www.takeda.com/newsroom/newsreleases/2024/fda-approves-subcutaneous-administration-of-entyvio/
The FDA approved Genentech's alectinib (Alecensa) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-alectinib-adjuvant-treatment-alk-positive-non-small-cell-lung-cancer
Drug Research
A study by Sweden’s Karolinska Institute found that half of all patients discharged from a hospital after a heart attack are treated with beta blockers unnecessarily. The study was published in the New England Journal of Medicine.
https://www.sciencedaily.com/releases/2024/04/240408130546.htm
A University of Manchester-led population-cohort study found multiple adverse outcomes associated with antipsychotic use in people with dementia. These include increased risks of stroke, venous thromboembolism, myocardial infarction, heart failure, fracture, pneumonia, and acute kidney injury, compared with non-use, but not ventricular arrhythmia. Absolute risk and risk difference between antipsychotic users and their matched comparators was largest for pneumonia. The study was published in The BMJ.
https://www.bmj.com/content/385/bmj-2023-076268
Scientists at France’s National Agency for Medicines and Health Products Safety found that long-term use of injectable progesterone (such as Depo Provera) is associated with increased brain tumor (meningioma) risk. But while the risk of meningioma was higher in women who took the medications for more than a year, one leading expert said the finding should not worry past or present users because the elevated risk remained “extremely small.” Most meningiomas are not usually cancerous and grow slowly, but because they can put pressure on the brain they often need surgical removal.
Using data from the French national healthcare system, the researchers identified 18,061 women, with an average age of 58, who had surgery between 2009 and 2018 to remove intracranial meningiomas.
Two oral pills, medrogestone and promegestone, were linked to a 4.1 and 2.7-fold greater risk of meningioma respectively; and medroxyprogesterone acetate, a contraceptive injection sold as Depo-Provera, was linked to a 5.6-fold higher risk. Because the study is observational, it cannot prove that the hormones cause the tumors. No excess risk was found for progesterone, dydrogesterone, or widely used hormonal intrauterine (IUD) systems.
The Guardian says that Pfizer, the manufacturer of Depo-Provera, said: “We are aware of this potential risk associated with long-term use of progestogens and, in collaboration with regulatory agencies, are in the process of updating product labels and patient information leaflets with appropriate wording.” The study was pubished in The BMJ.
https://www.theguardian.com/society/2024/mar/27/hormone-medication-brain-tumours-risk-progestogens-study
A study led by Heinz Wendell, a neurologist at the University of Münster, has identified different kinds of multiple sclerosis (MS) that may respond to different drugs. Researchers launched a multi-cohort study of 500 patients with early-stage MS. "Those newly sick people were a right fit because the immunological derailment has happened, but it’s not yet spread out and diverged,” Wendell said. The data suggest that peripheral blood analysis could be used to guide personalized treatment regimens for patients with MS.
The study was published in Science Translational Medicine.
https://www.statnews.com/2024/03/27/multiple-sclerosis-subtypes-treatment/
Drug-Induced Restless Legs Syndrome
Health professionals and many patients know that long-term use of antipsychotic drugs can trigger a side effect called "tardive dyskinesia," a movement disorder characterized by twitching or uncontrolled movements in the head, neck, face, and limbs. Less known is that a common neurological disorder called "Restless Legs Syndrome," or RLS, has also been linked to drugs, including antidepressants, antipsychotics, antihistamines, and nausea medications. This is called "drug-induced restless legs syndrome."
Here are some examples of drugs linked to RLS, along with links to patient experiences with RLS reported on the Ask a Patient database :
Benadryl (Antihistamine)
Risperdal (Antipsychotic)
Reglan* (Migraine/Nausea)
Metoclopramide* (Migraine/Nausea)
Seroquel (Antipsychotic)
Zyprexa (Antipsychotic)
Lexapro (Antidepressant)
Lamictal (Anticonvulsant)
Cymbalta (Antidepressant)
Latuda (Antipsychotic)
* Reglan (METOCLOPRAMIDE HYDROCHLORIDE) has FDA black box warning about risk of tardive dyskinesia
Read the entire article on drug-induced RLS at AskaPatient website.
https://www.askapatient.com/news/drug-induced-restless-legs-syndrome-RLS.asp
In this recent case study appearing in Cureus, a 33-year-old male experienced drug-related gastrointestinal (GI) symptoms after starting semaglutide for weight loss. Semaglutide was discontinued, and oral metoclopramide (a nausea drug) was administered to manage the GI symptoms. Subsequently, he developed RLS-like symptoms, which resolved within 48 hours of stopping metoclopramide.
https://www.cureus.com/articles/228857-an-unusual-case-of-an-acute-episode-of-restless-leg-syndrome-following-oral-metoclopramide-therapy#!/
Food & Supplement Tips
If you are trying to stay healthy by eating more fruits and vegetables, you may be concerned about pesticides. Consumer Reports recently analyzed the pesticide testing data provided by the Department of Agriculture, and identified which fruits and vegetables are more likely to be pesticide free, and which ones you might want to avoid or stick with organic versions. Testing results for blueberries, bell peppers, and green beans were concerning (designated "high risk"), while cantaloupe, peas, and carrots were lower risk. For the "high risk" categories, CR says it's ok to eat one serving a day. Check here for the entire chart of risk level for 59 fruits and vegetables from Apples to Winter squash for conventional/imported and regular/organic sources.
https://www.consumerreports.org/health/food-contaminants/produce-without-pesticides-a5260230325/
"The Checkup" describes five over-the-counter treatment options for stress and anxiety based on expert advice and scientific research. The five OTC treatments profiled include: magnesium, melatonin, L-theanine, Vitamin B Complex, and Omega-3s. They advise to always consult a healthcare provider before starting a new treatment, even if it has natural ingredients. Also, consumers should be aware that certain prescription drugs could have interactions with the supplements, especially magnesium.
https://www.singlecare.com/blog/over-the-counter-medicine-for-anxiety-and-stress/
If you have started taking a new vitamin, you may wonder, how long will it take for it to work? "The Checkup" reports that it depends on whether the vitamin is water-soluble and fat-soluble; water-soluble vitamins are absorbed and used quickly, within a few hours, while fat-soluble vitamins are stored and absorbed slowly and can take weeks to take effect. Unless you’re deficient in a vitamin, it will be hard to know whether or not it’s being absorbed without a blood test. Of the 13 essential vitamins, most are water-soluble; only vitamins A, D, E, and K are fat-soluble. Get more tips about vitamins, including factors that affect vitamin efficacy.
https://www.singlecare.com/blog/how-long-does-it-take-for-vitamins-to-work/
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