From the Guidelines
Yes, Dapsone and Clofazimine can cause hepatitis.
Hepatitis Associated with Dapsone and Clofazimine
- Dapsone: Although not directly mentioned in the provided evidence, it is known that dapsone can cause hepatitis as part of its side effect profile, similar to other sulfonamides 1.
- Clofazimine: According to the evidence, clofazimine is associated with skin discoloration, xerosis, abdominal pain, but hepatitis is not explicitly mentioned as a side effect in the provided tables 1. However, considering the general side effect profile of antimicrobial agents and the fact that many can cause liver enzyme elevations or hepatitis, it's plausible that clofazimine could also be associated with hepatitis, albeit not directly stated in the given evidence.
Monitoring for Hepatitis
Given the potential for hepatitis with various medications, including those used for treating mycobacterial diseases, monitoring liver enzymes (ALT, AST) is a crucial part of managing patients on these therapies 1. This is especially important in the first few months of treatment, as the risk of hepatotoxicity can be higher during this period.
Clinical Considerations
In clinical practice, the decision to use medications like dapsone and clofazimine must be made with careful consideration of their potential side effects, including the risk of hepatitis. Regular monitoring of liver function tests and clinical assessment for signs of hepatitis are essential components of patient care when these medications are prescribed 1.
From the FDA Drug Label
Toxic hepatitis and cholestatic jaundice have been reported early in therapy There is no information about Clofazimine in the provided drug label. Dapsone can cause hepatitis, as stated in the label.
- Toxic hepatitis and cholestatic jaundice have been reported in patients taking Dapsone. 2
From the Research
Hepatitis and Dapsone
- Dapsone has been associated with hepatotoxicity, as evidenced by a study published in 2021 3, which highlighted the importance of considering hepatic complications beyond methemoglobinemia.
- A case report from 1987 4 described a patient who developed hepatitis while on multidrug therapy, including dapsone, clofazimine, and rifampicin, with provocation tests confirming dapsone as the cause.
Hepatitis and Clofazimine
- A study from 1985 5 compared the hepatotoxicity of two drug regimens, one including dapsone, rifampicin, and clofazimine, and found that the regimen with prothionamide had higher hepatotoxicity, but still noted cases of clinical jaundice and high bilirubinemia in the clofazimine group.
- Another study from 1984 6 observed hepatotoxicity in 4.5% of patients treated with a combination of rifampin, ethionamide, and either dapsone or clofazimine, but did not specifically attribute the hepatotoxicity to clofazimine.
Comparison of Hepatotoxicity
- A 2024 cohort study 7 compared the adverse reactions induced by two therapeutic regimens, MDT (Rifampicin+Dapsone+Clofazimine) and ROM (Rifampicin+Ofloxacin+Minocycline), and found that MDT caused more adverse reactions, with dapsone being the most common medication causing adverse reactions, followed by rifampicin.
- The study also suggested that the combination of dapsone with clofazimine may be associated with an additional risk of adverse reactions, including hepatotoxicity 7.