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FDA tells GLP-1 makers to warn of potential vision loss side effect

Confirmed

Health Desk

In Short: Novo Nordisk, the maker of Ozempic and Wegovy, received a warning letter from the FDA over the past year for failing to report adverse side effects and deaths in a timely manner.

Seal of the U.S. Food and Drug Administration
Photo: United States Department of the Army / Wikimedia Commons (Public domain)

GLP-1 drugs get FDA warning of rare vision-loss side effect. CBS Chicago

The Food and Drug Administration (FDA) has issued a warning to pharmaceutical companies producing GLP-1 drugs, such as Novo Nordisk’s Ozempic and Wegovy, and Eli Lilly’s Mounjaro and Zepbound, to inform patients and doctors about a potential risk of a rare eye condition called non-arteritic anterior ischemic optic neuropathy (NAION).

NAION, sometimes referred to as an “eye stroke,” is caused by insufficient blood flow to the optic nerve, leading to sudden and often permanent vision loss. The FDA’s warning follows an intensive review of studies and clinical trials.

Novo Nordisk, the maker of Ozempic and Wegovy, received a warning letter from the FDA over the past year for failing to report adverse side effects and deaths in a timely manner. The company has since taken corrective actions but the FDA found the response inadequate.

In a statement on its website, Novo Nordisk said they have been working diligently to address the observations since the FDA inspection. The company has undertaken a broad, multi-pronged effort to address the FDA’s policies on reporting potential side effects and deaths.

The FDA noted that Novo Nordisk received a report of a patient on the GLP-1 semaglutide who died by suicide. However, the FDA also acknowledged the corrective and preventive actions taken by the company.

Eli Lilly, maker of Mounjaro and Zepbound, stated that the FDA’s drug safety communication applies to all medicines with GLP-1 RA activity and does not reference any findings specific to Lilly medicines.

GLP-1 drugs have become popular for their potent weight loss effects, but as with any drugs given to large populations, side effects can emerge in real-world use that were not observed in clinical trials.

The FDA’s warning is designed to ensure that accurate, reliable, and timely safety data are submitted for the monitoring of product safety and to ensure compliance with PADE regulations.

What this adds

The FDA’s warning highlights the ongoing need for pharmaceutical companies to promptly investigate and report adverse side effects and deaths to ensure public safety.

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