From the Guidelines
Orlistat should be avoided in patients with liver derangement due to the potential risk of serious liver injury, as highlighted by the FDA label warning and supported by recent clinical guidelines. The use of orlistat in patients with liver problems is a concern, as evidenced by the American Gastroenterological Association's clinical practice guideline on pharmacological interventions for adults with obesity, which notes the potential for serious liver injury due to orlistat 1. For individuals with deranged liver function, alternative weight management approaches, including dietary changes, physical activity, and other medications with better liver safety profiles, might be more appropriate. If orlistat is deemed necessary despite liver concerns, regular liver function monitoring is essential, with tests recommended before starting treatment and periodically thereafter, as part of a comprehensive management plan. Key considerations for the use of orlistat in patients with liver derangement include:
- Close medical supervision
- Regular liver function monitoring
- Patient education on symptoms of liver problems, such as yellowing of skin/eyes, dark urine, right upper abdominal pain, or unusual fatigue
- Alternative weight management approaches with better liver safety profiles. The potential benefits of orlistat in weight management must be carefully weighed against the potential risks, particularly in patients with pre-existing liver issues, as noted in the guideline on pharmacological interventions for adults with obesity 1.
From the FDA Drug Label
There have been rare reports of liver injury in people taking orlistat. Stop use and ask a doctor if you develop itching, yellow eyes or skin, dark urine or loss of appetite.
Orlistat is not explicitly safe for individuals with liver derangement. The label mentions rare reports of liver injury and advises stopping use if symptoms of liver problems occur, such as itching, yellow eyes or skin, or dark urine. However, it does not provide direct guidance on the use of orlistat in patients with pre-existing liver derangement. Therefore, caution is advised, and orlistat should be used with caution in patients with liver derangement, if at all. 2
From the Research
Orlistat Safety for Liver Deranged Patients
- Orlistat has been associated with severe liver injury, including fulminant hepatic failure, as reported in a case study published in 2014 3.
- The use of orlistat in patients with cirrhosis and liver transplant recipients has been reviewed, and while there is limited data, it appears that orlistat may be feasible for use in this population, but the decision to prescribe should be individualized based on the degree of renal and hepatic impairment, other co-morbidities, and concomitant medications 4.
- Several studies have investigated the efficacy of orlistat in patients with non-alcoholic fatty liver disease (NAFLD), and have found that it can improve liver fat content, alanine aminotransferase, and aspartate aminotransferase levels, as well as reduce body mass index and waist circumference 5, 6, 7.
- However, orlistat has also been associated with increased serum triglycerides, and its use should be carefully monitored in patients with liver disease 5.
- A systematic review and meta-analysis of randomized controlled trials found that orlistat was effective in reducing liver fat content and improving biochemical indicators of liver damage, but not in improving liver fibrosis score 6.
- A randomized clinical trial found that orlistat reduced liver fat content to a greater degree than conventional care, and was an independent predictor of steatosis improvement 7.