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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A case series described four patients (three women and a man; aged 21−66 years), who developed hepatocellular, cholestatic or mixed type liver damage during treatment with cetirizine for contact dermatitis or itching [routes not stated, times to reactions onsets not clearly stated and not all dosages stated]. In one of these patient, liver damage was occurred due to hypersensitivity to cetirizine.
Case 1, a 46-year-old man was hospitalised with a 7-day history of fatigue. He had been diagnosed with contact dermatitis and had received cetirizine 10 mg/day for three days. Biochemical tests showed total cholesterol of 228 mg/dL, triglycerides of 163 mg/dL, AST of 419 U/L, ALT of 419 U/L, ALP of 461 U/L and GGT of 545 U/L. His anti- hepatitis B level was positive and IgE was high....