Orlistat

FRIDAY, Jan. 12, 2024 -- Drugs like Wegovy and Ozempic, which have become a wildly popular way to lose weight or battle diabetes, show no link to suicidal thoughts or actions, the U.S. Food and Drug Administration said Thursday. “Our preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions,” an FDA review released Thursday stated. Still, the agency noted officials can't rule out that “a small risk may exist,” and it will continue to look into similar reports involving this class of weight-loss drugs, known as GLP-1 medications. The FDA review comes on the heels of a study funded by the National Institutes of Health that showed people taking semaglutide, the active ingredient in both Ozempic and Wegovy, had a lower risk of suicidal thoughts than those taking other drugs to treat obesity and diabetes. In that study, researchers tracked over 240,000 obese people and more than 1.5 million people with type 2 diabetes. They looked at the risk of suicidal ideation within six months of starting the medicines, as well as at later times. At six months, it found that among people taking the drug for weight loss, semaglutide was linked to a 73% lower risk of first-time suicidal ideation and a 56% lower risk of recurrent suicidal ideation. The drugs that semaglutide was compared to included bupropion, naltrexone, orlistat, topiramate and phentermine. For people with type 2 diabetes, the reductions were 64% and 49%, respectively. Here, the drugs that semaglutide was compared to included insulin, metformin and newer classes of medications known as DPP-4 and SGLT-2 inhibitors. Study author Dr. Rong Xu , a professor of biomedical informatics at Case Western Reserve University School of Medicine in Cleveland, told CNN that she decided to look into the issue after European regulators opened a probe into semaglutide and reports of suicidal thoughts last summer. Even though semaglutide was associated with a lower risk of suicidal ideation in the NIH study, the investigators wrote in a research briefing that the data “do not yet justify off-label treatment” for suicidal thoughts. Both Wegovy and another recently approved weight-loss drug known as Zepbound have warnings in their U.S. prescribing information about the risk of suicidal behavior and ideation. Sources U.S. Food and Drug Administration, news release, Jan. 11, 2024 Associated Press CNN Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Pictured: Novo Nordisk office/iStock, hapabapa A study published Wednesday suggests that more people are getting on and staying on one of pharma’s hottest drugs. One year after filling their first prescription, 40% of patients on Novo Nordisk’s Wegovy (semaglutide) were still taking it. That’s more than three times the adherence rate of older obesity medicines. The cohort study, published in the journal Obesity, utilized electronic health records and insurance claims data for adults with a BMI ≥30 kg/m2 from Ohio and Florida who had a prescription filled for an anti-obesity medication (AOM) between 2015 and 2022. Across all categories of AOMs, only 19% of the 1,911 patients included in the study were still taking the drugs at 12 months. In contrast to the 40% who stayed on Wegovy, only 13% of patients on Orexigen Therapeutics’ Contrave—a combination of antidepressant buproprion and addiction treatment drug nafltrexone—were still filling their prescriptions after a year. Even less patients continued taking Qsymia, Vivus’ combination drug for weight loss. No patients were continuing to take Orlistat by the 12-month mark. The study found that greater weight loss results at six months appeared to be directly associated with persistence at one year. Patients are more likely to stay on Wegovy because it tends to work better for most people. Adherence rates also varied depending on insurance carrier among those on private insurance. Obesity is a chronic condition, so to maintain benefit patients usually need to stay on the treatments indefinitely. An op-ed also published Wednesday in Obesity concludes that behavioral approaches do not produce lasting weight loss for most patients, as they do not address the physiology or external environment. The authors of the piece contend that AOMs coming to the market are “game changers” for treating obesity and that behavioral approaches “are complementary and must coexist if we are to make a significant, population-level impact on the obesity epidemic.” Novo Nordisk’s GLP-1 agonist has skyrocketed in popularity. Third-quarter 2023 sales logged over 700% growth, with a total around $3.1 billion in revenue for the first nine months of 2023. Wegovy isn’t the only game changer on the market. Last month, the FDA approved Eli Lilly’s tirzepatide for weight loss management. Marketed as Zepbound, a real-world analysis showed that Lilly’s tirzepatide beat Novo’s Wegovy for weight loss. Patients receiving Mounjaro, Lilly’s injectable type 2 diabetes drug with the same tirzepatide active ingredient as Zepbound, were three times as likely to drop 15% of their bodyweight than those on Ozempic. Weight loss was also faster on Mounjaro. Last week, Pfizer announced it was discontinuing development of its twice-daily weigh loss pill candidate after patients in a mid-stage study had trouble tolerating the side effects. Discontinuation rates were over 50% across all dosage forms. Nonetheless, the pharma giant is still moving forward with its pharmacokinetic study of a once-daily version of the drug, danuglipron, in the first half of 2024. The outcome of that study “will inform a path forward,” according to Pfizer’s announcement. Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.