Is it safe to take Mounjaro (tirzepatide) with a history of cholelithiasis (gallstones)?

From the Guidelines

If you have a history of cholelithiasis (gallstones), it is recommended to exercise caution when taking Mounjaro (tirzepatide) due to the potential increased risk of gallbladder-related complications, as suggested by the mechanism of action of GLP-1 receptor agonists 1. When considering the use of Mounjaro in patients with a history of gallstones, it is essential to weigh the potential benefits of the medication against the potential risks. The medication's effects on gallbladder function, including slowing gastric emptying and altering fat metabolism, may worsen existing gallstone conditions or trigger symptoms in previously asymptomatic gallstones 1.

Key Considerations

• Mounjaro is a GLP-1 receptor agonist, which can affect gallbladder function and potentially increase the risk of gallbladder-related complications in patients with a history of gallstones 1.
• Weight loss itself, regardless of method, can also increase the risk of gallstone formation or complications, so gradual weight loss is generally recommended for those with gallstones.
• Alternative diabetes or weight management medications with less impact on the gallbladder might be more appropriate for patients with a history of gallstones.
• Close monitoring for symptoms such as upper abdominal pain, nausea, vomiting, or yellowing of the skin is crucial if Mounjaro is prescribed to a patient with a history of gallstones.

Recommendations for Patients with Gallstones

• Consult with your healthcare provider before taking Mounjaro (tirzepatide) to discuss the potential risks and benefits.
• If prescribed Mounjaro, be aware of the potential symptoms of gallbladder-related complications and seek medical attention immediately if they occur.
• Consider alternative weight management or diabetes medications that may have a lower risk of gallbladder-related complications.
• Gradual weight loss is recommended to minimize the risk of gallstone formation or complications.

From the FDA Drug Label

Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In MOUNJARO placebo-controlled clinical trials, acute gallbladder disease (cholelithiasis, biliary colic, and cholecystectomy) was reported by 0.6% of MOUNJARO-treated patients and 0% of placebo-treated patients. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.

It is not explicitly stated that Mounjaro is safe to take with a history of cholelithiasis (gallstones). However, the label does mention that acute gallbladder disease, including cholelithiasis, has been reported in patients taking MOUNJARO.

• Key points:
  • Acute gallbladder disease, including cholelithiasis, has been reported in MOUNJARO clinical trials.
  • If cholelithiasis is suspected, diagnostic studies and clinical follow-up are recommended.
  • The label does not provide explicit guidance on the use of MOUNJARO in patients with a history of cholelithiasis.
  • Caution should be exercised when considering the use of MOUNJARO in patients with a history of gallstones, and patients should be monitored for signs and symptoms of gallbladder disease 2.

From the Research

Safety of Mounjaro (tirzepatide) with a History of Cholelithiasis (Gallstones)

There are no research papers provided that directly address the safety of taking Mounjaro (tirzepatide) with a history of cholelithiasis (gallstones). The provided studies focus on the treatment of gallstones with ursodiol (ursodeoxycholic acid) and do not mention Mounjaro (tirzepatide) 3, 4, 5, 6, 7.

Key Points from Provided Studies

• Ursodiol is an effective oral agent for dissolution of gallstones, particularly small, primarily cholesterol stones 3, 4, 5.
• The balance between cholesterol and bile acid synthesis in the liver is a key factor in gallstone formation 5.
• Ursodiol reduces the high levels of hydroxymethylglutaryl coenzyme A reductase in gallstone patients and does not inhibit endogenous synthesis of bile acids 5.
• Primary prevention of gallstone disease includes general "wellness" measures such as elimination of obesity, a high-fiber diet, and vigorous exercise 6.
• Secondary prevention involves nonsurgical approaches, including dissolution with ursodiol, for symptomatic gallstones 6.

Relevance to Mounjaro (tirzepatide)

• The provided studies do not address the safety of Mounjaro (tirzepatide) with a history of cholelithiasis (gallstones) 3, 4, 5, 6, 7.
• There is no information available in the provided studies to assist in answering the question about the safety of taking Mounjaro (tirzepatide) with a history of gallstones.