Ozempic
Ozempic burst onto the scene recently as a potential silver bullet against obesity. It was approved for medical use in the United States in 2017, and the internet quickly became awash with testimonies and pictures detailing incredible weight loss journeys. Such was its success that Ozempic shortages were often recorded in various locations across the country. Ozempic, however, was not initially intended to be a weight loss drug. The active drug, known as semaglutide is an antidiabetic medication that is marketed under various brand names including Ozempic, Wegovy, and Rybelsus. Semaglutide is a peptide which mimics the endogenously secreted glucagon-like peptide-1 (GLP-1). The intestines secrete GLP-1 after a meal and act to reduce hunger pangs and increase satiety. Semaglutide mirrors this action by binding to GLP-1 receptors. This helps diabetics achieve optimal glycemic control even in cases that are non-responsive to other anti-diabetic medications.
Before Ozempic, weight loss regimens usually involved strict caloric restriction and a lot of physical exercises, both of which were not always tolerable leading to significant levels of non-compliance. With Ozempic came an almost miraculous way to lose weight without dieting or exercising. It might have been a new drug, but what could possibly go wrong?
The Dark Side of Ozempic
While these drugs can be beneficial for some, there has been concern about certain side effects, even leading to a recent class-action lawsuit.
Mohit Sodhi et al in a study published by the Journal of the American Medical Association found that GLP-1 analogs (like semaglutide) caused increased risks of biliary disease, pancreatitis, bowel obstruction, and gastroparesis. Simon Jensen et al working at the University of Copenhagen found that treatment with GLP-1 analogs (like semaglutide) caused a reduction in bone density greater than that which could be explained by unaided weight loss. Jimena Hathaway et al gathering data over six years at Massachusetts Eye and Ear, Boston, found increased rates of nonarteritic anterior ischemic optic neuropathy among patients taking semaglutide and other GLP-1 analogs as compared with those taking other antidiabetic drugs.
Suddenly, it seemed like the floodgates were opened and multiple lawsuits were being raised for complications ranging from gastroparesis (due to destroyed stomach nerves) to amyotrophic lateral sclerosis to bile duct cancer. Most of those raising the lawsuits complain that the manufacturers did not give sufficient warning for these complications and that they have been essentially blindsided by side effects they have no way of avoiding. Following mounting complaints, a multidistrict litigation was opened in February 2024 to tie all Ozempic litigations into one case. The case was to be heard at the Eastern District of Pennsylvania federal court.
The journey so far
The multidistrict litigation proceedings have resumed after the appointment of a new judge, Judge Karen Spencer to oversee the process. Attempts have also been made to drag Eli Lilly into the lawsuit over their drug, Mounjaro. Mounjaro is the brand name for tirzepatide which is an analog of gastric inhibitory polypeptide (GIP), an anti-diabetic that is also used for weight loss. So far, the lawsuits for Mounjaro have stayed separate. Meanwhile, Novo Nordisk, the makers of Ozempic have continued to claim their innocence. They concede that there may be gastrointestinal side effects associated with Ozempic but insist that these side effects are mostly negligible. To further smudge the lines, Novo Nordisk claims that they have found evidence of counterfeit Ozempic pens in circulation in the United States. This could be used to argue that any serious side effects are a result of counterfeiting, and as such they bear no responsibility towards the injured users. Novo Nordisk is no stranger to litigation, so we can expect the cases to drag on for much longer.
References
Hathaway, J. T., Shah, M. P., Hathaway, D. B., Zekavat, S. M., Krasniqi, D., Gittinger, J. W., Jr, Cestari, D., Mallery, R., Abbasi, B., Bouffard, M., Chwalisz, B. K., Estrela, T., & Rizzo, J. F., 3rd (2024). Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide. JAMA Ophthalmology, e242296. Advance online publication. https://doi.org/10.1001/jamaophthalmol.2024.2296
Sodhi, M., Rezaeianzadeh, R., Kezouh, A., & Etminan, M. (2023). Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss. JAMA, 330(18), 1795–1797. https://doi.org/10.1001/jama.2023.19574
Jensen, S. B. K., Sørensen, V., Sandsdal, R. M., Lehmann, E. W., Lundgren, J. R., Juhl, C. R., Janus, C., Ternhamar, T., Stallknecht, B. M., Holst, J. J., Jørgensen, N. R., Jensen, J. B., Madsbad, S., & Torekov, S. S. (2024). Bone Health After Exercise Alone, GLP-1 Receptor Agonist Treatment, or Combination Treatment: A Secondary Analysis of a Randomized Clinical Trial. JAMA Network open, 7(6), e2416775. https://doi.org/10.1001/jamanetworkopen.2024.16775
