Drug Overdose

iStock, aprott While the regulator has not approved their use in type 1 diabetes, off-label prescribing for GLP-1 receptor agonists has sharply increased, according to researchers, who warn about the risk of serious side effects such as ketoacidosis. GLP-1 receptor agonists, including the blockbuster drugs semaglutide and tirzepatide, are increasingly being prescribed to patients with type 1 diabetes, despite having no FDA approval for this indication, according to a study published Wednesday in the Journal of the American Medical Association . From 2010 to 2023, the percentage of type 1 diabetes (T1D) patients that were given GLP-1 therapies surged from 0.3% to 6.6%. This increase was statistically significant, with a p-value less than 0.001, according to the study, which looked at electronic health record data from the healthcare database Epic Cosmos. Overall, the study included data from nearly 950,000 patients with T1D. Novo Nordisk’s semaglutide—marketed as Ozempic for type 2 diabetes (T2D) and Wegovy for weight loss—saw the biggest jump in T1D uptake, jumping from 0.2% in 2018 to 4.4% in 2023. Meanwhile, Lilly’s tirzepatide—approved as Mounjaro for T2D and Zepbound for obesity—was prescribed to 1.3% of T1D patients within a year of its initial approval in 2022 . Of note, the researchers pointed out that GLP-1 receptor agonists were most commonly prescribed to T1D patients with obesity. Aside from GLP-1 analogs, researchers also looked at the prescribing patterns of SGLT2 inhibitors—another popular class of T2D medication—and found similar trends. In 2010, 0.1% of T1D patients were treated with SGLT2 inhibitors, rising significantly to 2.4% in 2023. Corresponding author Hui Shao, of the Emory University Rollins School of Public Health, in a statement cautioned that the use GLP-1 and SGLT2 therapies in T1D “has increased sharply over the past decade,” despite their safety concerns in this indication—including ketoacidosis—a serious and potentially life-threatening complication that develops when the body fails to produce enough insulin. “This increase is likely to continue due to their significant benefits in weight management and cardiorenal protection observed in individuals with type 2 diabetes and the general obese population,” Shao said, noting that “urgent studies are needed” to better elucidate the benefits and risks of the GLP-1 and SGLT2 drug classes in T1D. Meanwhile, “caution should be used” when treating T1D patients with these medications. The warning from researchers comes amid the potential myriad of therapeutic benefits of GLP-1 receptor agonists beyond diabetes and obesity. Novo Nordisk in March won the FDA’s approval for Wegovy to lower the risk of cardiovascular death, heart attack and stroke in overweight or obese patients with cardiovascular diseases. Meanwhile, Lilly is also positioning Zepbound as an answer to obstructive sleep apnea , with an FDA decision expected as early as the end of the year. In addition, several studies have also detected signals of efficacy for a variety of other conditions, including Alzheimer’s disease , opioid overdose , tobacco use disorder and cirrhosis in metabolic dysfunction-associated steatotic liver disease .

Narcan nasal spray was made available over-the-counter by the FDA in March last year. Image credit: Shutterstock/ AnAdventureADa. Emergent BioSolutions has pledged to donate 20,000 doses of Narcan nasal spray (naloxone) to communities affected by opioid overdoses. Emergent said it is “working with businesses” to consider the availability of Narcan to sites including workplaces, facilities, and hospitality venues, amongst others, where accidental opioid emergencies could occur, as per an 8 October press release. The drive comes alongside the White House Challenge to Save Lives from Overdose, a nationwide initiative introduced by the Biden-Harris administration to increase training and access to opioid overdose reversal medications like Narcan. Emergent joined the Challenge in March this year as one of the main manufacturers of medication that treats opioid overdoses. An Emergent spokesperson confirmed to Pharmaceutical Technology that the donation is separate from the White House Challenge and builds upon the company’s existing donation programme. Narcan’s accessibility significantly increased last year when the US Food and Drug Administration (FDA ) approved the nasal spray for over-the-counter (OTC) use in March. At the time, it became the first opioid reversal medication available without the need for a prescription. Narcan generated $110m in revenue for Emergent in Q4 2023, up 22% from the year prior. See Also: FDA declines to approve Zealand Pharma’s hypoglycaemia therapy in infants Ipsen’s Elafibranor gains MHRA approval for PBC treatment Narcan works as an opioid receptor antagonist – it binds to opioid receptors and blocks the effects of opiates. The medication is recommended for use immediately after a suspected or known overdose of an opioid has occurred. Emergent has handed out more than 2,700 opioid emergency kits containing one carton of Narcan nasal spray and educational resources across several college campuses and public venues. As part of its inclusion in the White House’s Challenge, the biopharma has installed more than 40 opioid emergency wall units near first aid stations and automatic external defibrillators in its offices and facilities, along with providing 1,300 cartons of the medication to its employees this year. There are more than 80,000 deaths in America related to opioid overdose each year. However, for the first time, data points to the first meaningful decline in opioid overdose deaths – putting a stop to a death rate that had increased by more than 250% from 1999 to 2019. The Centers for Disease Control and Prevention (CDC), which reported the data , did not provide reasons for the downturn, but the decrease in deaths coincided with the availability of Narcan, along with other approved opioid overdose treatments. Emergent’s CEO Joe Papa said: “It is promising to see the recent decline in opioid overdose deaths for the first time in years.” Papa added the company remains “committed to playing [its] part in bringing down the number of opioid-related deaths by continuing to expand access efforts through the OTC availability of Narcan”. The news comes at a time when many of the lawsuits against drug manufacturers of prescription opioids are being settled . These include companies and pharmacy chains that have been accused of deceptive marketing practices, downplaying addiction risks and oversupplying prescription drugs. One of the largest opioid settlements to date included Johnson & Johnson , AmerisourceBergen , Cardinal Health and McKesson – together agreeing to pay $26bn to seven states in 2021. Pharmaceutical companies are also beginning to shift away from opioid-based pain medications, with several companies developing non-opioid candidates to manage pain including Vertex Pharmaceuticals and Lexicon Pharmaceuticals . Emergent meanwhile has been helping fight a different public health concern in the infectious disease space. The company won FDA approval to use its smallpox vaccine for the prevention of mpox in August, making it one of only two vaccine manufacturers against the disease, alongside Bavarian Nordic .

FRIDAY, Sept. 27, 2024 -- Opioid poisonings are increasing among children, according to a study presented at the annual meeting of the American Academy of Pediatrics, held from Sept. 27 to Oct. 1 in Orlando, Florida. Maria Quidgley-Martin, M.D., from the University of Florida in Gainesville, and colleagues described the demographic, clinical, and social characteristics of children with opioid poisoning evaluated for child maltreatment in a retrospective cohort study. Children who received a Suspected Child Abuse and Neglect team consultation for opioid exposure between June 2012 and December 2023 were analyzed. Sixty-nine consults for opioid ingestions were identified, with a fourfold increase from 2019 to 2023. The researchers found that 72 percent of the patients were younger than 2 years, and a notable proportion were non-Hispanic Black (11-fold increase from 2019 to 2023). The most common opioid was fentanyl. Most cases (87 percent) occurred in the patient's home or the residence of a relative. Altered mental status, abnormal breathing, and seizures were the most common symptoms reported. Eleven patients presented in cardiac arrest (nine aged younger than 2 years); on presentation, 71 percent had respiratory arrest or depression. Four children died due to fentanyl poisoning; all were aged younger than 2 years. About half of the patients' families (52 percent) had prior Child Protective Services involvement. In 65 percent of cases, there was a family history of opioid abuse. "Children are the overlooked tragic victims of the United States' opioid epidemic, and fentanyl is now the greatest danger," Quidgley-Martin said in a statement. "We need our first responders to always consider administering naloxone to unconscious pediatric patients in case they have unknowingly been exposed." Press Release More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.