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 -- Grandma's pill organizer. Fido's pain medication. A tossed-away tissue. All are potential sources of opioid poisoning for young children, researchers at the New Jersey Poison Control Center report. Their five-year look at 230 cases of opioid exposure in children between 1 month and 6 years of age shows how easily they get their hands on dangerous drugs. "I've seen too many kids in my practice at University Hospital who have gotten severely poisoned because they got opioids in their house," said senior study author Dr. Diane Calello , medical director at the Rutgers University-based poison center. Almost all of the exposures -- 97% -- were accidental. In all, 91% took place in the child's home and more than 84% of those kids wound up in a hospital. Many times, kids found a parent's meds. But 17.4% of cases involved grandparents' medications, underscoring a risk factor some might overlook. Older adults may not be as careful as Mom and Dad about securing their meds. Pet medications were involved in 4.3% of cases -- sometimes directly and sometimes from injesting meds that had been mixed with food like peanut butter and left out for the pet. Eight in 10 cases involved kids age 2 and under. The data came from reports to New Jersey Poison Control made between January 2018 and December 2022. Prescription opioid pills were the No. 1 source of danger -- but not the only one. Kids got access to used fentanyl patches, illicit drug paraphernalia and even traces of opioids left on discarded tissues and cotton balls. "One opioid pill could actually kill a 2-year-old," Calello said in a Rutgers news release. "And yet, a parent who may take that opioid pill every day may not realize that even though it's very familiar to them, it is deadly." Researchers called for broader education about the dangers of opioids in the home and said that should include anyone who might have meds in a home where kids are present. Calello said one potential solution is increasing access for parents and caregivers to naloxone, a medication that can reverse opioid overdoses. "I've seen several cases of young children where I thought that if this mom or dad had naloxone with them, they could have given it, and this child may have had a better outcome," she said. She said she hopes to study the effects of distributing naloxone to parents more widely. The findings appear in the December issue of The Journal of Pediatrics . Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.