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Novo Nordisk says it is working to make more; FDA warns against too much of a good thing.
Semaglutide, the drug used to treat Type 2 diabetes and obesity, also may help patients quit using tobacco.
Meanwhile, drug maker Novo Nordisk has said it is developing its pipeline to make more Wegovy, the branded form of semaglutide that has taken off among consumers since the U.S. Food and Drug Administration (FDA) approved it in 2021. FDA this month warned physicians, pharmacists and patients to check on proper dosage of compounded semaglutide – or face adverse reactions, and possibly hospitalization.
Research continues to examine the effects of semaglutide, the glucagon-like peptide-1 receptor agonist (GLP-1RA) drug that has become a pharmaceutical blockbuster. A new study found in new users, “semaglutide was associated with a significantly lower risk for medical encounters for TUD (tobacco use disorder) diagnosis compared with other antidiabetes medications.” The contrast was strongest compared with insulins and weakest compared with other GLP-1RAs.
“Semaglutide was associated with reduced smoking cessation medications and counseling,” the study said. “Similar findings were observed in patients with and without a diagnosis of obesity.”
Researchers examined data of 222,942 new users of antidiabetes medications, including 5,967 new users of semaglutide, from December 2017 to March 2023. The numbers came from the TriNetX Analytics platform, which aggregates data from electronic health records from about 113 million patients in 64 large health care organizations.
Semaglutide was compared with seven other antidiabetes drugs:
Smoking tobacco products “is the leading cause of preventable morbidity and mortality including cardiovascular diseases, cancer types, and all-cause mortality,” the study said. It’s also difficult to quit – in 2022, just 9.6% of adult cigarette smokers successfully stopped smoking in the past year.
The researchers noted FDA-approved smoking cessation drugs and behavioral interventions have helped people quit, although the U.S. Preventive Services Task Force has acknowledged those have not changed much in 30 years.
“This could change if randomized clinical trials confirm the therapeutic benefits of semaglutide and other GLP-1RAs for treating TUD,” the study said. “The fact that semaglutide (and other GLP-1RAs) leads to weight loss becomes particularly relevant because smoking cessation is associated with weight gain, which contributes to relapse, particularly in women.”
Patients also could benefit from better glycemic control and reduced rise of cardiovascular ailments and cancer, and semglutide has a higher adherence rate than other medications, including the other GLP-1RA drugs, in patients with Type 2 diabetes, the study said.
While the findings appeared beneficial for patients, the study had limitations, for example, lacking data on severity of patients’ tobacco use disorder and on medication adherence. The results do not justify clinicians prescribing semaglutide off-label to help patients quit smoking, the study said.
The study, “Association of Semaglutide With Tobacco Use Disorder in Patients With Type 2 Diabetes,” was published in Annals of Internal Medicine.
The researchers, funded by the National Institutes of Health, said semaglutide already has been studied for possible suicidal ideation, cannabis use disorder, alcohol use disorder, and for cancer risks.
Semaglutide is growing in use – as of April, an estimated 25,000 new patients a week began using Wegovy, the branded form made by Novo Nordisk. That was roughly four times the U.S. patient starts compared to December 2023, according to the company’s “Updates about Wegovy (semaglutide) injection 2.4 mg supply” web page. The site is dedicated to explaining the Wegovy supply chain, and Novo Nordisk is paying $11 billion for three Catalent production facilities to make more in a deal expected to be compleged by the end of this year.
Novo Nordisk also is investing billions in Denmark and France to expand or build production sites to meet demand, according to the company.
“The demand for Wegovy reinforces the unmet need and has strengthened our promise to not only develop innovative medicines but to partner, raise awareness, and advocate to change how obesity is understood, diagnosed, and treated,” the website said.
With the drug in short supply, patients have turned to compounding pharmacies to get usable blends of semaglutide. They also are getting too much medicine due to dosing errors because many of the patients did not have experience using self-injectable products, or health care providers miscalculated the amounts patients should take.
Overdoses have led to patient reports of severe nausea, vomiting and hypoglycemia. That can prompt long observation periods because the medicine has a half-life of about one week. Additional overdose effects include fainting, headache, migraine, dehydration, acute pancreatitis, and gall stones, according to FDA.
In several reports, patients mistakenly injected 50 units of the drug instead of five, based on amounts measured in a U-100 (1 milliliter) insulin syringe, according to FDA. There also were reports of health care providers wrongly prescribing wrong amounts of the drug, based on converting milligrams to units or milliliters.
“FDA recognizes the substantial consumer interest in using compounded semaglutide products for weight loss,” the FDA warning said. “However, compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, effectiveness or quality. Therefore, compounded drugs should only be used to meet a patient’s needs if the patient’s medical needs cannot be met by an available FDA-approved drug.”
The FDA warning, “FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products,” was published July 26.
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