36 Cases of Acute Cholecystitis in Patients Taking Glucagon-like Peptide-1 (GLP-1) Receptor Agonists in FDA FAERS
A recent Research Letter written by three FDA employees with the Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Division of Pharmacovigilance, discussed some postmarketing cases of acute gallbladder disease related to Byetta, Trulicity, Ozempic, and Adlyxin, which are drugs used for the treatment of diabetes and obesity.
This August 29, 2022 item, "Acute cholecystitis associated with the use of glucagon-like peptide-1 receptor agonists reported to the US Food and Drug Administration", published by the medical journal JAMA Internal Medicine (subscription required), starts with the following:
The required labeling for some glucagon-like peptide-1 receptor agonists (GLP-1 RAs) indicated for glycemic control in patients with type 2 diabetes include warnings and precautions regarding acute gallbladder disease in the US Prescribing Information (the prescribing information approved by the US Food and Drug Administration [FDA]), while others do not. The FDA recently reviewed the FDA Adverse Event Reporting System (FAERS) to identify cases of acute cholecystitis (AC) associated with the GLP-1 RA products that did not have warnings and precautions regarding acute gallbladder disease.
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For more details, we turn to this August 30, 2022 MedPage Today news report, "FDA Data Link Diabetes Drug Class to Gallbladder Disease":
An analysis of [the FDA Adverse Event Reporting System (FAERS)] turned up three dozen cases of acute gallbladder disease in patients taking glucagon-like peptide-1 (GLP-1) receptor agonists for diabetes or weight loss, including three deaths.
From 2005 to 2016, postmarketing cases of acute cholecystitis were identified in 21 patients taking exenatide (Byetta), in seven taking dulaglutide (Trulicity), in seven on semaglutide (Ozempic), and in one patient taking lixisenatide (Adlyxin)....
Thirty of the cases were treated with cholecystectomy and two resolved with ursodeoxycholic acid treatment and discontinuation of the GLP-1 receptor agonist. Of the three patients who died, two had pancreatitis and one died from fatal liver necrosis.
In 42% of the cases, patients experienced disease onset within 90 days from the time of treatment initiation, according to the findings in JAMA Internal Medicine....
Median patient age was 55, and 53.1% of the cases involved women. Thirty-three of the patients were taking the drugs for type I or II diabetes, with the remaining taking the drug for weight loss. Overall, 21 patients were overweight or obese, 19 had hyperlipidemia, six had non-alcoholic fatty liver disease, and one had periportal fibrosis.
We will continue to watch for adverse events involving acute gallbladder disease related to Byetta, Trulicity, Ozempic, and Adlyxin for diabetes or weight loss.
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