United States: The FDA updated warning labels of all the GLP-1 RA on November 5, mentioning that these drugs should not be used with general anesthesia or deep sedation due to the risk of pulmonary lung risks.
More about the news
The products involved are semaglutide (Ozempic, Rybelsus, Wegovy); liraglutide (Saxenda, Victoza); and the dual GIP/GLP-1 agent tirzepatide (Mounjaro, Zepbound).
According to the FDA spokesperson, “This was a safety-related labeling change for the glucagon-like peptide 1 receptor agonist product class,” Medscape Medical News reported.
As per the latest addition, an additional subsection is included under “Warnings and Precautions,” stating, “There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations,” medscape.com reported.
Moreover, “Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking [these drugs], including whether modifying preoperative fasting recommendations or temporarily discontinuing [them] could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking [a GLP-1 RA],” it added.
What more was the warning added?
Additionally, the warning was also added to the Adverse Reactions section of the label, as well as the Postmarketing Experience section, which includes, “Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation.”
About patient information
The Medication Guide section recommends that patients inform their healthcare provider if they are planning for an operation or other procedures where anesthesia or deep sleep is Administered.
They are informed that they may experience serious side effects from the GLP-1 RAs they are using, such as food or fluids inhaled into the lungs during surgery or other procedures that involve the use of anesthesia or deep sedation.
The patients using a GLP-1 RA should inform all their physicians that they are, prior to undergoing surgery or any other medical procedures.
Furthermore, in the Patient Counseling section of the label, the health providers are also advised to inform patients regarding risks related to pulmonary aspiration during general anesthesia or deep sedation.
It added, “Inform patients that [the drug] may cause their stomach to empty more slowly, which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures.”
Physicians are also encouraged to advise patients not to undergo any surgeries or any other procedures without informing the doctor if he or she is under [a GLP-1 RA].