The Engel Family’s Struggle with Ozempic and Legal Battles Over Side Effects

The Engel family’s story highlights potential complications linked to the diabetes medication Ozempic, specifically for Todd Engel who operated heavy machinery in suburban Maryland for decades.

In early 2023, Todd Engel started using Ozempic, a GLP-1 drug, for diabetes management. On New Year’s Eve, he experienced a sudden vision loss in his right eye, described as a black patch blocking his vision. His doctor diagnosed him with optic neuropathy, known as NAION, resulting from tiny strokes that restrict blood flow to the eye.

Upon questioning, the doctor informed the Engels that no connection to Ozempic had been reported. Months later, a JAMA Ophthalmology study revealed higher NAION rates among Ozempic users. Unaware, Engel continued the medication until his left eye also went dark, the same as the previous year.

Currently, over one in 10 Americans use GLP-1 drugs for weight loss. However, such medications carry several side effects. Engel’s lawsuit against Novo Nordisk claims that the company did not adequately inform about the NAION risk. This lawsuit joins other lawsuits alleging serious harm from GLP-1 drugs.

Statements from Novo Nordisk reference later research casting doubt on any association between their drug and NAION, claiming the lawsuits lack merit.

The legal debate focuses on whether GLP-1s truly caused the harm. Observational data shows a correlation, not causation, which requires more extensive investigation. Two medical groups, the American Academy of Ophthalmology and the North American Neuro-Ophthalmology Society, critiqued the study. They emphasized it did not prove causation but acknowledged a possible link requiring further research. They do not currently advise against GLP-1 usage.

Adverse Event Reporting

The FDA maintains a database for reporting adverse events linked to drugs, which aid in research and label adjustments. While primarily voluntary, it’s a critical tool for identifying potential issues.

NPR’s examination of this database uncovered over 1,000 optic neuropathy reports since 2024 related to GLP-1s. Novo Nordisk claims such conditions are rare in clinical trials and advises ongoing data sharing with the FDA.

The FDA is assessing the NAION risks, determining if regulatory action is necessary. Attorney Jonathan Orent, involved in consolidated lawsuits against GLP-1 drugs, argues for immediate warning updates similar to those in Europe due to clinical population limitations.

Orent’s cases involve numerous plaintiffs alleging serious conditions like pancreatitis. He claims earlier warnings might have altered the impact on affected users, like Engel, who regrets losing abilities such as working and basic activities.

Complexity in Reporting and Oversight

Diabetes and obesity involve complex body systems and associated risks, making it difficult to isolate drug-related issues. Emory University’s Mohammed Ali, a diabetes specialist, highlighted challenges in reporting due to pre-existing conditions and uncertainty about exact drug causes.

Additionally, online sales have increased GLP-1 accessibility, complicating oversight. Pharmacist Robert Miller notes the rise in patients experiencing side effects without adequate medical supervision, leading to more calls to poison control centers.

These legal proceedings involve plaintiffs like the Engels seeking damages and better warning systems. Shelley Engel emphasizes the need for warnings that might have prevented her husband’s blindness.

This report included contributions by NPR correspondent Sydney Lupkin.