Children's Health Defense
Lawsuit Alleges Maryland Man With Diabetes Became Blind After Taking Ozempic
A Maryland man who took Ozempic and then became legally blind is suing the drug’s manufacturer, arguing it had an obligation to warn patients that loss of sight could be a possible side effect. Todd Engel, 62, was prescribed Ozempic in 2023 to manage his Type 2 diabetes. The lawsuit said about four months later, Engel was diagnosed with nonarteritic anterior ischemic optic neuropathy, or NAION, a condition in which a loss of blood flow to the optic nerve causes sudden and irreversible vision loss.
NAION occurs in up to about 10 out of every 100,000 people over age 50, according to the American Academy of Ophthalmology. Ozempic and others in the same class of drugs, called GLP-1s, were designed for Type 2 diabetes and have become wildly popular for weight loss in recent years.
Some studies have indicated that patients prescribed semaglutide, the active ingredient in Ozempic, for diabetes or weight loss may be at increased risk of developing NAION. Experts say while evidence is growing that there is an association between Ozempic and NAION, it’s still too early to know definitively if semaglutide raises the risk of developing the condition — especially because diabetes itself is a risk factor for NAION and other eye issues.
Novavax Says Vaccine Application Still ‘Approvable,’ Despite FDA Delay
Novavax claims it can surmount the latest regulatory hurdle hindering its quest to win full U.S. clearance of its COVID-19 vaccine, saying Monday it believes its application is still approvable pending an agreement with the U.S. Food and Drug Administration (FDA) on a postmarketing clinical trial.
Last week, Novavax revealed the agency had requested what’s known as a postmarketing commitment to further study the shot in clinical tests. On Friday, The Wall Street Journal reported the FDA had asked Novavax to conduct an additional randomized clinical trial, which would be a costly and time-consuming additional step for the company…
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