Todd Engel, a Maryland resident, had been taking Ozempic, a GLP-1 drug, for diabetes since early 2023. He began experiencing vision problems, which his doctor diagnosed as a form of optic neuropathy called NAION. Engel's condition worsened, and he lost vision in both eyes. He has since filed a lawsuit against the maker of Ozempic, Novo Nordisk, alleging the company failed to warn patients and doctors about the risk of NAION.
Engel's case is part of two main ongoing consolidated lawsuits alleging life-threatening or life-altering harm from GLP-1 drugs. The lawsuits claim that the drugs caused serious side effects, including NAION, pancreatitis, and gallstones. Novo Nordisk has stated that the cases are without merit, citing subsequent research that casts doubt on the link between their GLP-1 drug and NAION.
The Food and Drug Administration (FDA) keeps a database tracking adverse events related to pharmaceuticals, including GLP-1 drugs. NPR found over 1,000 reports of optic neuropathy linked to GLP-1s since 2024, out of nearly 190,000 reports made about the drug during that period. The FDA has undertaken its own study to assess NAION risks and will determine the need for regulatory action once its assessment is complete.
Attorney Jonathan Orent, a lead court-appointed attorney on the two major multi-district litigation lawsuits, argues that drug makers ought to update warnings to doctors and patients about the risks of GLP-1 drugs, even if the conditions are rare. He cites the limitations of clinical trials in detecting rare events and the importance of real-world population data.
The boom in online sales of GLP-1 drugs, often with little to no medical supervision, adds to the challenge of tracking side effects. Pharmacist Robert Miller at the West Texas Poison Control Center reports an increase in calls from patients experiencing vomiting and other GLP-1 side effects. This raises concerns about the need for closer monitoring of patients taking these drugs.
Emory University diabetes specialist Mohammed Ali notes that obesity and diabetes are complex metabolic diseases that affect many organs, making it difficult to pinpoint whether problems that patients encounter on GLP-1 drugs are caused by the drugs themselves. He did not report three patients who developed serious problems while taking GLP-1s to the FDA's adverse events database, as he was uncertain about the cause.
The uncertainty surrounding the frequency of side effects from GLP-1 drugs has significant implications for patients and the pharmaceutical industry. As the use of these drugs continues to grow, with over one in 10 Americans taking a GLP-1 drug for weight loss, according to a recent Gallup analysis, it is crucial to gather more data and conduct further research to understand the risks and benefits of these medications.
Key points
- Over 1,000 reports of optic neuropathy linked to GLP-1s have been made to the FDA's adverse events database since 2024.
- Two main ongoing consolidated lawsuits allege life-threatening or life-altering harm from GLP-1 drugs.
- The FDA is currently assessing NAION risks associated with GLP-1 drugs and will determine the need for regulatory action once its assessment is complete.
