US FDA Reports, Use of Some Diabetes Drugs Linked to Acute Gallbladder Disease


In a recent study, the US Food and Drug Administration (FDA) its review of the FDA Adverse Event Reporting System (FAERS). The review was conducted to identify the cases of acute cholecystitis (AC) linked to the intake of glucagon-like peptide-1 (GLP-1) agonists, which do not have precautions for acute gallbladder disease.

The study found 36 cases of the acute cholecystitis among patients taking GLP-1 receptor agonists for diabetes and weight loss medications, and 42 percent of the patients had experienced the disease within the first three months of the treatment.

The researchers from the US FDA identified the postmarketing cases of acute cholecystitis from 2005 to 2016 in around 21 patients who look exentide, seven on semaglutide, one taking lixisenatide, and seven patients taking dulaglutide.

According to a researcher, Daniel Woronow, from the US Food and Drug Administration (FDA), the case series is in accordance with the results of the meta-analysis of 76 random trials that detected an association between GLP-1 and cholecystitis receptor agonists.

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He also said the potential mechanisms include the suppression of cholecystokinin secretion, with weight loss, and decreased gallbladder emptying. The study findings are significant as some of the GLP-1 RAs, are indicated for blood sugar control in type 2 diabetes patients that require labelling, including warnings and precautions regarding acute gallbladder disease in the United States Prescribing Information.