Adverse Drug Events Reporting News

• SGLT2 Inhibitors Begin to Show Potential in Rheumatology Sodium-glucose cotransporter-2 inhibitors are not approved to treat gout, lupus, or lupus nephritis, but clinicians are uncovering signs of benefits in these conditions.
  MDedge News, January 08, 2024
• African Psychedelic Remarkably Improved TBI-Related Symptoms Treatment with ibogaine (psychoactive agent) led to "remarkable" improvement in severe functional disability and psychiatric symptoms related to TBI, early findings suggested.
  Medscape Medical News, January 08, 2024
• Which Therapies Reduce Daytime Symptoms of Insomnia? Zolpidem and behavior therapy each reduce daytime symptoms of insomnia such as fatigue, functional impairments, and depressive symptoms, data suggested.
  Medscape Medical News, January 07, 2024
• Eli Lilly Offers Obesity Drug Directly to Consumers Eli Lilly launched its direct-to-patient portal on Thursday, providing its obesity medicine (as well as diabetes and migraine drugs) direct to the consumer.
  WebMD Health News, January 05, 2024
• Active Surveillance for Low-Risk PCa: Sprint or Marathon? No easy algorithm for men who prefer to watch, rather than treat, their prostate cancers.
  Medscape Medical News, January 05, 2024
• FDA Evaluating 3 Side Effects Reported for Weight Loss Drugs A new report listed potential links between GLP-1 agonists and alopecia, aspiration during surgery, and suicidal ideation.
  WebMD Health News, January 05, 2024
• Wegovy, Ozempic Not Linked to Increase in Suicidal Thoughts, US Study Finds A large U.S. study found no evidence that taking Novo Nordisk's Ozempic or Wegovy is tied to an increase in suicidal thoughts, researchers reported on Friday.
  Reuters Health Information, January 05, 2024
• Weight-loss Drugs: Who, and What, Are They Good For? Powerful weight-loss medicines like Novo Nordisk's Wegovy leapt into public view in 2023, from social media to doctors' offices and cocktail parties, offering a new way to...
  Reuters Health Information, January 02, 2024
• Building a Toolkit for the Treatment of Acute Migraine Selecting a treatment plan to deal with acute migraine attacks is like putting together a toolkit of possible therapies which can be individualized for each patient, one expert said.
  Medscape Medical News, December 28, 2023
• Elafibranor Appears Effective, Safe for PBC Treatment with elafibranor showed significantly greater improvements in relevant biochemical indicators of cholestasis than the placebo.
  Medscape Medical News, December 28, 2023
• AHA Names Top CVD Advances for 2023 Advances in stroke, a novel antihypertensive, and new evidence that diabetes drugs may offer CVD benefits for those without diabetes are among the top developments in 2023, on the AHA's annual list.
  Medscape Medical News, December 28, 2023
• Keeping Injectable Products in Cosmetic Dermatology Safe The rapid increase in intradermal injections of hyaluronic acid and Botox has been accompanied by an increase in side effects.
  Medscape Medical News, December 26, 2023
• 'Real-time Experiment': Compounded GLP-1s on Coupon Site Purveyors on coupon sites like Groupon are marketing weight loss programs that include compounded semaglutide and tirzepatide.
  Medscape Medical News, December 26, 2023
• Many Patients With Type 2 Diabetes Stop Meds After a Year Often, patients with type 2 diabetes on second-line medication discontinue their therapy within a year, warn US researchers who highlight the need for new prescribing approaches.
  Medscape Medical News, December 21, 2023
• New Research Aims to Unravel Both ME/CFS and Long COVID A 2-day research conference sponsored by the US National Institutes of Health highlighted research that points to mechanisms that suggest potentially "druggable" pathways.
  Medscape Medical News, December 21, 2023
• Migraine Experts: Head-to-Head Drug Comparisons Better Placebo-controlled trials are insufficient for decisions that affect medication availability in EU member states.
  Medscape Medical News, December 19, 2023
• Restarting CGRPs for Migraine May Lower Response Rate Restarting a CGRP monoclonal antibody (mAb) after a gap in treatment may lower response rate, a new study suggests. However, switching to a different mAb may counter this effect.
  Medscape Medical News, December 18, 2023
• Thiazide Diuretics May Promote Hyponatremia The risk for hyponatremia was higher with thiazide drugs compared with nonthiazide drugs in older adults and patients with comorbidities.
  Medscape Medical News, December 18, 2023
• Structure's Diabetes Pill Misses Weight-loss Expectations in Mid-stage Trial Structure Therapeutics' diabetes pill missed market expectations for weight loss in a mid-stage trial and fell short of results from a similar treatment from rival Eli...
  Reuters Health Information, December 18, 2023
• One Fifth of Americans Report Use of Hemp-Derived Products Adults who used delta-8 THC were more likely to live in states where cannabis use is illegal.
  Medscape Medical News, December 18, 2023
• ASH 2023 ASH 2023: Equity, Sickle Cell, and Real-Life Outcomes Health equity, sickle cell disease, and the thoughtful use of artificial intelligence and social media are among the key themes to be presented at the annual meeting of the American Society of Hematology.
  MDedge News, December 04, 2023
• Experimental Tx Restores Cognitive Function in Chronic TBI In a first-in-humans trial, deep brain stimulation restored executive function in five individuals with moderate to severe traumatic brain injury 3-18 years after injury.
  Medscape Medical News, December 04, 2023
• EU Watchdog Seeks More Safety Data From GLP-1 Drugmakers The EU's drug watchdog will request more data from makers of a class of diabetes and weight-loss drugs including Ozempic and Wegovy to further investigate suicidal thoughts in some patients taking them.
  Reuters Health Information, December 01, 2023
• Pfizer Drops Twice-Daily Version of Obesity Pill Over Side Effects Pfizer said on Friday it would not advance a twice-daily version of oral weight-loss drug danuglipron into late-stage studies after most patients dropped out of its midstage trial with high rates of side effects such as nausea and vomiting.
  Reuters Health Information, December 01, 2023
• EMA Committee Recommends Label Update for Some Decongestants The European Medicines Agency's safety committee on Friday recommended changes to product information for all medicines that contain the ingredient pseudoephedrine to address safety concerns related to neurological and heart-related side effects.
  Reuters Health Information, December 01, 2023
• No Adverse Effects From Steroids in Pregnant Women With EoE 'Our recommendations about the use of steroids among this population are based on the safety data extrapolated mainly from pregnant women with asthma.'
  MDedge News, December 01, 2023
• What Is the Dark Side of GLP-1 Receptor Agonists? Doctors who prescribe this class of medication should be aware of the rare side effects with which it is associated, said an obesity expert.
  Medscape Medical News, December 01, 2023
• Meta-Analysis: Suicide Risk Not Increased With Isotretinoin In fact, those treated with the drug for severe acne may have a lower risk for suicide attempts 2-4 years after treatment, according to the study authors.
  MDedge News, December 01, 2023
• Avoid Anti-HER2 Cancer Therapies During Pregnancy Women with HER2-positive breast cancer who receive HER2-targeted therapies during pregnancy face a higher risk for severe adverse outcomes to their fetus or newborn, new research indicates.
  Medscape Medical News, November 29, 2023
• Alert FDA Warns of Potentially Lethal Reaction to Seizure Meds Levetiracetam and clobazam can cause a rare but serious drug reaction with eosinophilia and systemic symptoms that can be life threatening if not diagnosed and treated quickly, the FDA warns.
  Medscape Medical News, November 28, 2023
• Alert FDA OKs New Agent to Block Chemotherapy-Induced Neutropenia The new colony-stimulating factor from China proved comparable to pegfilgrastim (Neulasta) in clinical testing.
  Medscape Medical News, November 28, 2023
• EADV 2023 At 52 Weeks, Hair Growth Still Climbing on Deuruxolitinib With response curves still climbing at follow-up to date, the results are 'truly, truly remarkable.'
  MDedge News, November 28, 2023
• AANEM 2023 Novel Myasthenia Gravis Therapies Bring Opportunities New treatments for myasthenia gravis are bringing new promise to patients, but their use must be balanced against short-term and long-term risks.
  MDedge News, November 27, 2023
• Metoclopramide Nasal Spray Eases Gastroparesis in Women A nasal spray formulation of metoclopramide was well tolerated and reduced symptoms of diabetic gastroparesis in women with moderate to severe baseline symptoms in a phase 3 study
  Medscape Medical News, November 27, 2023
• Circadian Calorie-Burning Cycles Altered in Obesity Among people with obesity, the lowest point of energy expenditure is not during sleeping hours, as seen in those without obesity.
  Medscape Medical News, November 21, 2023
• AHA 2023 Single Injection Reduces Blood Pressure for 6 Months The RNA interference therapeutic targeting synthesis of angiotensinogen lowered BP in adults with mild to moderate hypertension for up to 6 months after one dose in the phase 2 KARDIA-1 study.
  Medscape Medical News, November 20, 2023
• FDA Panel Flags Insufficient Data for Chronic Cough Drug Advisers to the FDA said that data on Merck's chronic cough drug do not provide sufficient evidence to prove its clinical benefit for patients.
  Reuters Health Information, November 17, 2023
• FDA Panel Voices Concerns Over Two Lymphoma Rushed Approvals 'The consensus of the advisory committee is that we have significant concerns about the very prolonged delay and getting these confirmatory studies underway.'
  MDedge News, November 17, 2023
• New Consensus Guide on Rare Drug Hypersensitivity Reaction Experts provided parameters to help clinicians, but they acknowledged the limited evidence base for drug reaction with eosinophilia and systemic symptoms.
  Medscape Medical News, November 17, 2023
• AHA 2023 More Evidence of Better Outcomes With 120 mm Hg BP Target Intensive lowering of blood pressure to a systolic target < 120 mm Hg reduced cardiovascular events among high-risk individuals by 12% vs a target < 140 mm Hg in the ESPRIT trial.
  Medscape Medical News, November 16, 2023