ileus, nausea, vomiting and diarrhea leading to dehydration Hepatobiliary Hyperbilirubinemia, elevations of liver enzymes, cholestasis and hepatitis Hypersensitivity rash, pruritus, angioedema and anaphylactic reactions Neoplasms Medullary thyroid carcinoma Neurologic Dysesthesia Pulmonary Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation
Preclinical studies in rodents have shown an association between GLP-1 receptor activation and thyroid C-cell changes, although a direct causal link in humans has not been established, and UK/EU SmPCs for authorised GLP-1 RAs do not list MTC or MEN2 as a formal contraindication
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In addition, section 1833(t)(2) of the Act provides that, subject to certain exceptions, the items and services within an APC group cannot be considered comparable regarding the use of resources if the highest cost for an item or service in the group is more than 2 times greater than the lowest cost for an item or service within the same group (referred to as the 2 times rule)
