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FDA Data Link Diabetes Drug Class to Gallbladder Disease

A news report published on medpagetoday.com states that a recent examination of the U.S. Food and Drug Administration’s adverse event reporting system data shows nearly 40 cases of acute gallbladder disease and three deaths in patients who take glucagon-like peptide-1 (GLP-1) receptor agonists. Glucagon-like peptide-1 receptor agonists are often used to treat diabetes or weight loss. According to […]

Fda data link diabetes drug class to gallbladder disease

GLP-1 Lawsuits

A news report published on medpagetoday.com states that a recent examination of the U.S. Food and Drug Administration’s adverse event reporting system data shows nearly 40 cases of acute gallbladder disease and three deaths in patients who take glucagon-like peptide-1 (GLP-1) receptor agonists. Glucagon-like peptide-1 receptor agonists are often used to treat diabetes or weight loss.

According to the report, from 2005 until 2016, twenty-one patients reported taking glucagon-like peptide-1 receptor agonists and were diagnosed with acute cholecystitis in the post marketing case studies. Twenty-one patients were taking exenatide (Byetta), seven patients were taking dulaglutide (Trulicity), seven patients were on semaglutide (Ozempic), and one patient was taking lixisenatide (Adlyxin). Thirty of the adverse event reports stated that the patients were treated with cholecystectomy (removal of the gallbladder), and two patients were treated with ursodeoxycholic acid and discontinuation of their GLP-1 receptor agonist medications. Two of the three patients who passed away had pancreatitis, and the third victim died from fatal liver necrosis.

The report states that 42% of the patients experienced a disease onset within three months from the time their treatment began, according to JAMA Internal Medicine. A recent meta-analysis of 76 randomized trials found a connection between cholecystitis and GLP-1 receptor agonists.

The prescribing information for these medications was recently updated to include precautions and warnings concerning these serious health risks. The news report also states some GLP-1 receptor agonists used for glycemic control in type 2 diabetes patients initially carried the warnings about an increased risk for acute gallbladder disease. However, some medications did not contain the warnings.

The 36 cases of acute cholecystitis had been identified after reviewing pathology reports, physician diagnoses, or identifying symptoms treated with cholecystectomy. Not included in the study were patients who had cholelithiasis or cholecystitis before they were treated with a GLP-1 receptor agonist or in cases where other factors may have contributed to the diseases.

Thirty-three patients were given the GLP-1 receptor agonist drugs for type I or II diabetes, while the remaining patients were given the GLP-1 receptor agonists for weight loss. Nineteen of the twenty-one patients developed hyperlipidemia, six more were diagnosed with non-alcoholic fatty liver disease, and one developed periportal fibrosis. The findings also discovered that fourteen of the patients were given a starting dose of GLP-1 receptor agonist, fourteen other patients were given the maximum recommended dose, and four patients were given a medium amount of the medications.

The time to disease onset was much shorter in patients given the starting dose as compared to patients who were given the maximum dose.

Did you lose a loved one, or did you or a loved one take a GLP-1 receptor agonist and now suffer from liver necrosis, pancreatitis, acute gallbladder disease, or did your loved one pass away? You may be qualified to file a lawsuit against the drug manufacturer for harm caused by these medications.

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Parker Waichman LLP helps families recover monetary compensation for harm caused by toxic chemicals. For your free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).

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