FDA Updates Ozempic Label With Anesthesia Warning
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The Food and Drug Administration has updated the warning label for Ozempic and similar drugs to alert consumers of a potentially serious complication involving anesthesia.
The new label, which was updated this month, warns patients taking Ozempic that they may be at heightened risk for pulmonary aspiration if they are undergoing general anesthesia or deep sedation while taking the drug.
Pulmonary aspiration is a condition where a patient who is under anesthesia inhales some of their stomach contents into their lungs. The condition, which is why patients are generally asked to fast before surgical procedures, is very serious and can be fatal.
According to the National Institute of Health, nearly half of patients who aspirate during surgery at minimum develop a lung-related injury.
The new warnings for Ozempic and other GLP-1 agonists result from the fact that these drugs can slow gastric emptying, meaning that the typical fasting procedures given to patients may not be sufficient to prevent pulmonary aspiration.
Yet the solution may not be as simple as Ozempic patients fasting for longer than usual. The FDA noted that current data is insufficient to recommend how patients can lessen the risk.
Wegovy, which is labeled specifically for weight loss, also received the label update.
Health Concerns Tied to Ozempic Continue to Grow
The FDA warning label change is the latest update as health concerns surrounding GLP-1 agonists have been on the rise.
Ozempic lawsuits have been filed claiming it and similar drugs have caused serious intestinal issues. As of November, more than 1,200 lawsuits have been consolidated in multidistrict litigation against the makers of Ozempic, Wegovy and other drugs. Most of these lawsuits claim possible ties to gastroparesis, which is a condition that causes movement of the stomach to slow or stop.
According to Johns Hopkins Medicine, this condition can result in vomiting, nausea, abdominal pain and even the obstruction of the stomach. Lawsuits claim that Novo Nordisk, the makers of Ozempic, failed to warn of these risks.
Ozempic has also recently been tied to concerns of vision loss. A JAMA Ophthalmology study that was published this summer found that Ozempic’s active ingredient semaglutide may be associated with nonarteritic anterior ischemic optic neuropathy (NAION).
NAION is a condition where blood flow decreases to one eye, which can result in vision loss. Lawyers have begun to investigate potential lawsuits related to those who have developed this condition.
