April 16, 2023: Safety label update for seizure drug; FDA ramps up opioid warnings; prediabetes therapy; "nano" cancer med; hormonal contraceptives and breast cancer; premature menopause; BP meds
Drug Safety Label Changes
Seizure/epilepsy drug Carbatrol (carbamazepine) had a safety label change to warn of cardiac risk of atrioventricular (AV) block, liver and kidney damage, and hypersensitivity reaction to other drugs. Possible drug interactions include prescription drugs acetazolamide and aprepitant, along with other Rx, herbal and over-the-counter treatments.
Carbatrol Safety Label Change (click the April 11 update on the Safety-related Labeling Change page)
Carbatrol Patient Reviews at Ask a Patient
The U.S. Food & Drug Administration (FDA) announced a new communication plan and drug safety label changes to better inform patients about the risks of extended release/long-acting (ER/LA) opioid analgesics. Example drugs include Nucynta ER (tapentadol) and Opana ER (oxymorphone hydrochloride). The FDA aims to communicate the risk of opioid-induced hyperalgesia (OIH), a condition where opioids cause an increase in pain (hyperalgesia) or an increased sensitivity to pain (allodynia). Check the press release for the complete list of risks that will be addressed by safety label updates and education efforts.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-new-safety-label-changes-opioid-pain-medicines
Essential Medicines
For the first time, an obesity drug is being considered for inclusion on the World Health Organization's "essential medicines list," a bi-annual list of drugs that is used to guide government purchasing decisions in low- and middle-income countries. A panel of advisers to the WHO will review and propose the updated essential medicines list by September 2023. Once-daily injectable weight loss drug Saxenda (liraglutide) is being considered for the list and would mark a new approach to global obesity by the health agency. Some public health experts warn against introducing such medicines too broadly as a solution to a complex condition that is still not completely understood. Liraglutide is also the ingredient in diabetes drug Victoza.
https://www.reuters.com/business/healthcare-pharmaceuticals/who-consider-adding-obesity-drugs-essential-medicines-list-2023-03-29/
Victoza Patient Reviews at Ask a Patient
Diabetes Treatments
Johns Hopkins School of Medicine led a review on the diagnosis and management of prediabetes, an intermediate stage between normal glucose regulation and diabetes that affects 1 in 3 adults in the US and about 720 million individuals worldwide. Intensive lifestyle modification, consisting of calorie restriction, increased physical activity (≥150 min/wk), self-monitoring, and motivational support, decreased the incidence of diabetes by 6.2 cases per 100 person-years during a 3-year period. Metformin decreased the risk of diabetes among individuals with prediabetes by 3.2 cases per 100 person-years during 3 years. Authors conclude that first-line therapy for prediabetes is lifestyle modification including weight loss and exercise or metformin. Lifestyle modification is associated with a larger benefit than metformin. The study was published in JAMA.
https://jamanetwork.com/journals/jama/article-abstract/280351
In 2016, Public Citizen’s Health Research Group designated the once-daily injectable diabetes drug Toujeo (insulin glargine recombinant) as "Do Not Use for Seven Years" because the drug was not a major breakthrough for treating diabetes. Now that seven years have passed with no new major safety concerns being identified, its designation has changed to "Limited Use." Public Citizen recommends that patients only use Toujeo after first trying other insulins, including Lantus, Basaglar and NPH insulin (Humulin, Novolin).
As of August 2022, the FDA-approved product labeling for Toujeo confirms that it is no better than Lantus as a method to control blood sugar in patients with diabetes based on data from several randomized clinical trials in adults, older adults and children. Public Citizen’s Worst Pills, Best Pills notes that in an effort to boost its market share, Sanofi-Aventis tried (but failed) to persuade the FDA to permit Toujeo to be labeled as a more effective and safer alternative to its Lantus product, which lost patent protection in 2016.
https://www.worstpills.org/newsletters/view/1524 (this article is paywalled; abstract available)
Toujeo Solstar Patient Reviews at Ask a Patient
Lantus Patient Reviews at Ask a Patient
Implantable Cancer Drug Delivery Shows Promise
Houston Methodist Research Institute experimented with an implantable nano device (NDES) to deliver CD40 monoclonal antibodies (mAb), a promising immunotherapeutic agent, to reduce pancreatic tumors in mice using a fourfold lower dosage than traditional immunotherapy treatment. Researchers noted that even though the NDES device was only inserted in one of two tumors in the same animal model, the neighboring tumor without the device also shrank. "We see this device as a viable approach to penetrating the pancreatic tumor in a minimally invasive and effective manner, allowing for a more focused therapy using less medication," said Alessandro Grattoni, Ph.D., co-corresponding author and chair of the Department of Nanomedicine at Houston Methodist Research Institute.
Other medical technology companies offer intratumoral drug-eluting implants for cancer therapeutics, but those are intended for shorter duration use. The Houston Methodist nanofluidic device is intended for long-term controlled and sustained release, avoiding repeated systemic treatment that often leads to adverse side effects. The study was published in Advanced Science.
https://phys.org/news/2023-04-implantable-device-smaller-grain-rice.html
Women’s Health
Women who enter the menopause early (before age 40) may be more likely to develop dementia, according to Brigham and Women’s Hospital researchers. However, they found that starting hormone replacement therapy (HRT) around the time of diagnosis (not years after) appeared to remove the risk. The findings are tentative, and need to be confirmed by larger studies. Up to 10% of women experience premature menopause, defined as menopause that occurs spontaneously before the age of 40. The results were published in JAMA Neurology.
https://www.massgeneralbrigham.org/en/about/newsroom/press-releases/menopause-hormone-therapy-alzheimers-disease-risk
Gillian Coughlan, the lead author of the study that suggests that women who experience early menopause should start hormone replacement therapy right away to lower their risk of developing Alzheimer's, spoke about her findings on a Boston news program.
https://www.wcvb.com/article/study-author-on-early-menopause-and-hormone-replacement-therapy/43543079
In recent years, progestin-only methods of contraception — including pills, injectables, implants, and intrauterine devices (IUDs) — have become more popular than estrogen-progestin combinations. Cancer researchers from University of Oxford aimed to find out relative risk of cancer among the different hormonal contraceptives, including the progestin-only versions. Analysis of patient data from the Clinical Practice Research Datalink on 10,000 women less than 50 years old with breast cancer showed that taking the progestin-only version has the same risk of breast cancer as estrogen-progestin combined contraceptive pills. The risk of cancer goes up with patient age while taking the drug but declines after stopping the hormonal contraception. The study was published in PLOS-Medicine.
https://www.technologynetworks.com/cancer-research/news/combined-and-progesterone-only-contraceptives-have-similar-risk-of-breast-cancer-371365
Depending how legal battles play out and how the FDA responds to challenges to the medical abortion drug mifepristone, doctors say they will continue to offer medication abortions without mifepristone, using only the second drug used in the regimen, misoprostol. Unlike mifepristone, which only has two makers (the generic approved for medical abortion by GenBioPro and the brand name Korlym approved to treat Cushing's Disease by Corcept), misoprostol has more than 50 generic makers according to the DailyMed database. Misoprostol is commonly combined with diclofenac sodium to treat arthritis (Arthotec brand name) while reducing the incidence of NSAID-induced ulcers, and used alone (many generics) to reduce incidence of stomach ulcers. Listen to or read this NPR Health Shots story on the topic.
https://www.npr.org/sections/health-shots/2023/04/10/1168857095/misoprostol-only-medical-abortion
Mental Health Treatment
A new kind of psychotherapy, Eye Movement Desensitization and Reprocessing (EMDR), can help people with mental health symptoms caused by distressing experiences. But unlike a regular psychotherapy treatment, the healing process with EMDR can happen more quickly, in as few as 6 to 12 sessions. Plus, you don’t have to talk extensively about or relive your traumatic experiences. The therapy has a three-step protocol.
https://www.discovermagazine.com/mind/emdr-therapy-what-is-it-and-how-effective-is-the-treatment
Blood Pressure Treatment Tips
People's Pharmacy's radio host, syndicated columnist and pharmacologist Joe Graedon discusses the results of a recent Uppsala University (Sweden) study on four common blood pressure medications. He explains why the researchers found that "One size (or one BP drug) does not fit all!" The study was published in JAMA.
https://www.peoplespharmacy.com/articles/which-bp-drug-works-best-for-you
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