FDA Adds Unusual Warning to GLP-1 Capsules

— Labels now caution about pulmonary aspiration probability

by Kristen Monaco, Senior Crew Creator, MedPage On the present time November 8, 2024

Labels of all GLP-1 receptor agonists now lift a warning about pulmonary aspiration all the intention in which thru in model anesthesia or deep sedation.

The warning affects all treatments containing GLP-1 receptor agonists, in conjunction with semaglutide (Ozempic, Wegs, Fishing), tirzepatide (Mounjaro, Zepbound), dulaglutide (Trulicity), exenatide (Byetta, Bydureon BCise), liraglutide (Victoza, Saxenda), and lixisenatide (Adlyxin).

This drug class, exciting injectable and oral medications outdated college for weight-loss and diabetes, delays gastric emptying, thus rising dangers of aspiration and regurgitation below anesthesia.

“There were uncommon postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing optionally available surgical procedures or procedures requiring in model anesthesia or deep sedation who had residual gastric contents in spite of reported adherence to preoperative fasting suggestions,” the updated labels snarl. As a result, patients on a GLP-1 agent might well presumably also just composed recount healthcare suppliers of any deliberate surgical procedures or procedures.

Despite the warning, the original labels assemble no longer provide pulmonary aspiration probability mitigation suggestions — love a immediate relieve prior to surgical treatment or modified preoperative fasting — asserting available data are insufficient.

The foundation of a pre-surgical GLP-1 hiatus has divided anesthesiologists as of gradual, with a little evaluation indicating a low aspiration probability with GLP-1 exhaust, and other stories suggesting the reverse.

Correct final week, the American Society of Anesthesiologists (ASA), in conjunction with several other medical societies, reversed its 2023 steering which firstly urged a 1-week and 1-day relieve of injectable and oral GLP-1 brokers, respectively, prior to optionally available surgical treatment.

As a replacement, the original ASA steering states that the bulk patients can continue their medication up till the day of surgical treatment but might well presumably also just composed discover a liquid weight-reduction scheme for twenty-four hours earlier than the scheme, counting on explicit conditions.