EU Probes Anesthesia Complication for New Weight-Loss Drugs

By Naomi Kresge and | September 29, 2023

European authorities are investigating whether popular weight-loss and diabetes drugs including Novo Nordisk A/S’s Wegovy may be linked to complications during anesthesia.

The European Medicines Agency’s safety committee, PRAC, is discussing the potential safety issue during its meeting this week. The probe comes after the American Society of Anesthesiologists issued guidance in June to suggest that patients skip a dose of the drugs prior to surgery.

Because the drugs delay the emptying of the stomach, there’s a risk that some food may remain even if patients fast prior to surgery, increasing the risk that stomach contents come up the esophagus and spill into the lungs, the US anesthesiologists’ association said.

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This aspiration of stomach contents “can be catastrophic” for some patients, David Johnson, the chief of gastroenterology at Eastern Virginia Medical School, said in an interview last month. Fluid from the stomach entering the lungs can put patients at risk of developing pneumonia. “It can be insidious in some cases.”

Diabetes can also play a role in delayed stomach emptying, or gastroparesis. More studies are needed in patients with obesity to determine what role, if any, the medications are playing in these side effects, Johnson said.

PRAC’s review covers a broad group of drugs similar to Wegovy, known generically as semaglutide, including Novo’s blockbuster diabetes medicine Ozempic and Eli Lilly & Co.’s diabetes drug Mounjaro.

The evidence available thus far on the use of such drugs around the time of surgery is “sparse,” and safety data from post-marketing surveillance and clinical trials hasn’t shown that semaglutide caused aspiration in the lungs, Novo said in a statement. The decision on using the drugs should be at the discretion of the treating physician, the company said.

The EMA declined to comment beyond its published agenda item. Eli Lilly didn’t immediately respond to a request for comment.

Photograph: Packets of Wegovy move along a conveyor at the Novo Nordisk A/S production facilities in Hillerod, Denmark, on Monday, June 12, 2023. Photo credit: Carsten Snejbjerg/Bloomberg

Topics Profit Loss Europe

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