Risk of Pulmonary Aspiration During Anesthesia with GLP-1 Agonists, FDA Issues New Safety Warning
Recently the U.S. Food and Drug
Administration (FDA) issued updated safety warnings for all glucagon-like
peptide 1 receptor agonists (GLP-1 RAs) about the risk of pulmonary aspiration
during procedures that require general anesthesia or deep sedation. The updated
news was published in the ‘Drug Safety-related Labeling Changes’ portal of the
U.S.F.D.A website.
The medications whose safety labeling
was updated include semaglutide (Ozempic, Rybelsus, Wegovy); liraglutide
(Saxenda, Victoza); and the dual glucose-dependent insulinotropic polypeptide
(GIP)/GLP-1 tirzepatide (Mounjaro, Zepbound). The updated product labeling
included “Warnings and Precautions,” as a new subsection. This change was done
as there were rare postmarketing reports of pulmonary aspiration among patients
taking GLP-1 RAs who underwent elective surgeries or procedures requiring
general anesthesia or deep sedation.
Despite the patients following
the preoperative fasting guidelines, some of these unfortunate incidents were reported.
There is insufficient data to provide specific recommendations on vindicating
this risk as per the FDA. There is uncertainty on whether adjusting
preoperative fasting protocols or temporarily stopping GLP-1 RA treatment could
reduce the retained gastric contents and the aspiration. Evidence suggests that
GLP-1 RAs may cause delayed gastric emptying, leading to the presence of
residual stomach contents even after recommended fasting periods. This slower
gastric motility increases the risk of complications during anesthesia, as
residual contents can inadvertently enter the lungs (aspiration) when patients
are under deep sedation or anesthesia.
To mitigate the risk of pulmonary
aspiration, patients are now advised to inform their healthcare providers if
they take any GLP-1 RAs before scheduling surgery or anesthesia procedures. In
addition to this, the new warning was also added to the “Adverse Reactions” and
“Postmarketing Experience” sections of the drug labels to recognize pulmonary
aspiration linked to GLP-1 RAs during surgeries requiring anesthesia.
The information in the medication
guide section of the drug labels has also been updated and patients are also instructed
to inform the healthcare providers, especially anesthesiologists and surgeons,
about their use of GLP-1 RAs before undergoing any surgical procedures.
Responsibility has also been
levied on the Healthcare providers to advise and counsel the patient’s risk
associated with GLP-1 RAs. Information about the delaying of stomach emptying, and
risks during surgery or procedures involving anesthesia should be given before
prescribing these medications. So that the patients can in turn inform the healthcare
providers before undergoing any procedures.
importance of communication between the patients and healthcare providers
keeping in mind the safety of the patients. Despite not having enough evidence
regarding the specific alterations to preoperative fasting or medication
discontinuation protocols this update is a proactive step by FDA concerning the
patient safety considering the widespread use of these drugs for various health
conditions.
