Has etoricoxib (Arcoxia) been associated with increased liver-function tests (ASAT, bilirubin and A

Fråga: Has etoricoxib (Arcoxia) been associated with increased liver-function tests (ASAT, bilirubin and ALP)?

A 58-year-old man with sarcoidosis, autoimmune cholangitis, cirrhosis and portal hypertension is prescribed etoricoxib. Four weeks later his bilirubin (28 umol/l, normal <26 umol/l), ASAT (0.83 normal <0.80 ukat/l) and ALP (4.9 ukat/l normal 0.8-4.6 ukat/l) values were increased. All lab values were normal before treatment initiation.

Sammanfattning: There are a few reports of increased liver-function tests during etoricoxib treatment. In the present case the patient had a known liver disease and his increased liver values might be due to disease and not the drug. However, an increase in liver values caused by etoricoxib can not be excluded.

Svar: It is mentioned in the SPC (Summary of Products Characteristics) text of etoricoxib that approximately 1% of etoricoxib treated patients experience increased ASAT and ALAT levels (approximately threefold elevations) (1).

In a randomised dose-ranging trial of etoricoxib in patients with osteoarthritis 1.3 % (8 of 617) of the patients had drug-related changes in laboratory values. Some, number not specified, had increased ASAT and/or ALAT values. One patient discontinued the trial due to increased ASAT and ALAT values (2).

In a clinical trial measuring the pharmacokinetics of etoricoxib in patients with hepatic impairment, one of 26 patients had increased ALAT value (about three times higher than normal maximum value). This patient also had an increased ASAT value but no other abnormal liver function values (3).

In WHO:s adverse drug reactions database there is one report of increased ALAT due to etoricoxib (4).