Acute Cholecystitis Associated With the Use of Glucagon-Like Peptide-1 Receptor Agonists Reported to the US Food and Drug Administration

doi:10.1001/jamainternmed.2022.3810

. 2022 Oct 1;182(10):1104-1106.

doi: 10.1001/jamainternmed.2022.3810.

Acute Cholecystitis Associated With the Use of Glucagon-Like Peptide-1 Receptor Agonists Reported to the US Food and Drug Administration

Daniel Woronow¹, Christine Chamberlain¹, Ali Niak¹, Mark Avigan², Monika Houstoun³, Cindy Kortepeter¹

Affiliations

¹ Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Division of Pharmacovigilance, US Food and Drug Administration, Silver Spring, Maryland.
² Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, Maryland.
³ Center for Drug Evaluation and Research, Office of New Drugs, Division of Diabetes, Lipid Disorders, and Obesity, US Food and Drug Administration, Silver Spring, Maryland.

PMID: 36036939
PMCID: PMC9425280
DOI: 10.1001/jamainternmed.2022.3810

Acute Cholecystitis Associated With the Use of Glucagon-Like Peptide-1 Receptor Agonists Reported to the US Food and Drug Administration

Daniel Woronow et al. JAMA Intern Med. 2022.

. 2022 Oct 1;182(10):1104-1106.

doi: 10.1001/jamainternmed.2022.3810.

Authors

Daniel Woronow¹, Christine Chamberlain¹, Ali Niak¹, Mark Avigan², Monika Houstoun³, Cindy Kortepeter¹

Affiliations

¹ Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Division of Pharmacovigilance, US Food and Drug Administration, Silver Spring, Maryland.
² Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, Maryland.
³ Center for Drug Evaluation and Research, Office of New Drugs, Division of Diabetes, Lipid Disorders, and Obesity, US Food and Drug Administration, Silver Spring, Maryland.

PMID: 36036939
PMCID: PMC9425280
DOI: 10.1001/jamainternmed.2022.3810

No abstract available

Plain language summary

This case series identifies cases reported in the US Food and Drug Administration Adverse Event Reporting System of acute cholecystitis associated with use of glucagon-like peptide-1 receptor agonists that did not have gallbladder disease warnings in their labeling.

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Conflict of interest statement

Conflict of Interest Disclosures: None reported.

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References

1. He L, Wang J, Ping F, et al. . Association of glucagon-like peptide-1 receptor agonist use with risk of gallbladder and biliary diseases: a systematic review and meta-analysis of randomized clinical trials. JAMA Intern Med. 2022;182(5):513-519. doi:10.1001/jamainternmed.2022.0338 - DOI - PMC - PubMed
1. Smits MM, Van Raalte DH. Safety of semaglutide. Front Endocrinol (Lausanne). 2021;12:645563. doi:10.3389/fendo.2021.645563 - DOI - PMC - PubMed
1. Rehfeld JF, Knop FK, Asmar A, Madsbad S, Holst JJ, Asmar M. Cholecystokinin secretion is suppressed by glucagon-like peptide-1: clue to the mechanism of the adverse gallbladder events of GLP-1-derived drugs. Scand J Gastroenterol. 2018;53(12):1429-1432. doi:10.1080/00365521.2018.1530297 - DOI - PubMed
1. Keller J, Trautmann ME, Haber H, et al. . Effect of exenatide on cholecystokinin-induced gallbladder emptying in fasting healthy subjects. Regul Pept. 2012;179(1-3):77-83. doi:10.1016/j.regpep.2012.08.005 - DOI - PubMed
1. US Food and Drug Administration . Drugs@FDA: FDA approved drug products. Accessed June 24, 2022. https://www.accessdata.fda.gov/scripts/cder/daf

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[1] He L, Wang J, Ping F, et al. . Association of glucagon-like peptide-1 receptor agonist use with risk of gallbladder and biliary diseases: a systematic review and meta-analysis of randomized clinical trials. JAMA Intern Med. 2022;182(5):513-519. doi:10.1001/jamainternmed.2022.0338 - DOI - PMC - PubMed

[2] He L, Wang J, Ping F, et al. . Association of glucagon-like peptide-1 receptor agonist use with risk of gallbladder and biliary diseases: a systematic review and meta-analysis of randomized clinical trials. JAMA Intern Med. 2022;182(5):513-519. doi:10.1001/jamainternmed.2022.0338 - DOI - PMC - PubMed

[3] Smits MM, Van Raalte DH. Safety of semaglutide. Front Endocrinol (Lausanne). 2021;12:645563. doi:10.3389/fendo.2021.645563 - DOI - PMC - PubMed

[4] Smits MM, Van Raalte DH. Safety of semaglutide. Front Endocrinol (Lausanne). 2021;12:645563. doi:10.3389/fendo.2021.645563 - DOI - PMC - PubMed

[5] Rehfeld JF, Knop FK, Asmar A, Madsbad S, Holst JJ, Asmar M. Cholecystokinin secretion is suppressed by glucagon-like peptide-1: clue to the mechanism of the adverse gallbladder events of GLP-1-derived drugs. Scand J Gastroenterol. 2018;53(12):1429-1432. doi:10.1080/00365521.2018.1530297 - DOI - PubMed

[6] Rehfeld JF, Knop FK, Asmar A, Madsbad S, Holst JJ, Asmar M. Cholecystokinin secretion is suppressed by glucagon-like peptide-1: clue to the mechanism of the adverse gallbladder events of GLP-1-derived drugs. Scand J Gastroenterol. 2018;53(12):1429-1432. doi:10.1080/00365521.2018.1530297 - DOI - PubMed

[7] Keller J, Trautmann ME, Haber H, et al. . Effect of exenatide on cholecystokinin-induced gallbladder emptying in fasting healthy subjects. Regul Pept. 2012;179(1-3):77-83. doi:10.1016/j.regpep.2012.08.005 - DOI - PubMed

[8] Keller J, Trautmann ME, Haber H, et al. . Effect of exenatide on cholecystokinin-induced gallbladder emptying in fasting healthy subjects. Regul Pept. 2012;179(1-3):77-83. doi:10.1016/j.regpep.2012.08.005 - DOI - PubMed

[9] US Food and Drug Administration . Drugs@FDA: FDA approved drug products. Accessed June 24, 2022. https://www.accessdata.fda.gov/scripts/cder/daf

[10] US Food and Drug Administration . Drugs@FDA: FDA approved drug products. Accessed June 24, 2022. https://www.accessdata.fda.gov/scripts/cder/daf

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Acute Cholecystitis Associated With the Use of Glucagon-Like Peptide-1 Receptor Agonists Reported to the US Food and Drug Administration

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Acute Cholecystitis Associated With the Use of Glucagon-Like Peptide-1 Receptor Agonists Reported to the US Food and Drug Administration

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