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Side effects due to RO 10-9359 (Tigason). A retrospective study
Summary
Tigason treatment can cause clinical side effects like dry lips and hair loss. Some patients experienced abnormal liver function tests, with two cases showing toxic hepatitis.
Area of Science:
- Dermatology
- Hepatology
- Clinical Pharmacology
Background:
- Tigason (acitretin) is a retinoid used for dermatological conditions.
- Understanding its side effect profile, particularly hepatotoxicity, is crucial for patient safety.
Purpose of the Study:
- To investigate the clinical and hepatotoxic side effects of Tigason treatment.
- To evaluate liver function test abnormalities and liver biopsy findings in patients receiving Tigason.
Main Methods:
- Retrospective study analyzing data from 27 patients with normal baseline liver function tests.
- Monitoring of clinical symptoms and liver function tests (ALT, AST, LDH, ALP) during Tigason therapy.
- Review of liver biopsy results for patients with persistent liver function abnormalities.
Main Results:
- Common clinical side effects included dryness of lips/mucous membranes (n=14) and hair loss (n=5).
- Abnormal liver function tests (LFTs) were observed in 7 patients; 2 developed persistent elevations.
- Two patients showed toxic hepatitis changes on liver biopsy.
Conclusions:
- Tigason is associated with various clinical side effects.
- Hepatotoxicity, including toxic hepatitis, can occur in a subset of patients treated with Tigason.
- Regular monitoring of liver function is recommended during Tigason therapy.