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Author: Admin | 2025-04-28
Individuals with cholestasis; patients with a history of gallbladder disease should consult a healthcare provider before use.[27971] [60877] Substantial weight loss can increase the risk of cholelithiasis or gallbladder disease. In a clinical trial of orlistat, the rates of cholelithiasis as an adverse event were 2.9% (47/1649) for patients randomized to orlistat and 1.8% (30/1655) for patients randomized to placebo. The long-term effects on gallstone formation have not been determined; orlistat use does not appear to influence gallbladder motility.[27971] According to the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines, close monitoring for cholelithiasis is recommended in patients undergoing weight loss therapy, regardless of modality. Effective preventative measures for obese patients at risk for cholelithiasis include a slower rate of weight loss, increasing/including some dietary fat in the diet (assuming the patient has been on a very low-calorie diet containing little or no fat), or administration of ursodeoxycholic acid. The AACE/ACE Obesity Guidelines also recommend monitoring for pancreatitis due to a proven association between pancreatitis and obesity and reports of pancreatitis occurring in patients receiving orlistat. The drug should be withheld if pancreatitis occurs or the patient has a previous history of pancreatitis.[62881]Carefully consider the risk: benefit ratio of using orlistat in patients with hepatic disease. There have been rare postmarketing reports of serious liver injury, hepatotoxicity, and hepatocellular necrosis in patients treated with orlistat by prescription or without a prescription, with some of these cases resulting in acute hepatic failure, liver transplant, or death. Some of these reports involved patients with other potential risks for liver injury. Patients should be instructed to report any symptoms of hepatic dysfunction (anorexia, pruritus, jaundice, dark urine, light-colored stools, or right upper quadrant pain) while taking orlistat. When these symptoms occur, orlistat and other suspect medications should be discontinued immediately and liver function tests (LFTs), including ALT and AST levels, obtained.[27971] [40642] [60877] Orlistat may be best avoided in patients with hepatitis treated with antiretroviral drugs. Loss of virological control has been reported in non-hepatitis patients treated with antiretroviral drugs for human immunodeficiency virus (HIV), and
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