Side Effects Due to RO 10-9359 (Tigason)

Abstract

In a retrospective study clinical and hepatotoxic side effects caused by Tigason treatment are investigated. The material consists of data on 27 patients with normal liver function tests at the beginning of treatment. The clinical side effects encountered were: dryness of lips and mucous membranes (n = 14), diffuse hair loss (n = 5), epistaxis (n = 1) and conjunctivitis (n = 1). Abnormal liver function tests (glutamic oxaloacetic transaminase, glutamic pyruvic transaminase, lactate dehydrogenase and alkaline phosphatase) were found in 7 patients: 3 developed slight transient elevation of parameter during treatment, 2 transient elevation of more parameters, normalizing despite continued therapy in 1 and in the other normalizing after discontinuation. Finally 2 patients developed persistent elevation of one or more parameters. In the last 2 patients liver biopsy showed changes of toxic hepatitis.

Toxic Hepatitis due to Combination Therapy with Methotrexate and Etretinate in Psoriasis

“…A few well-doc umented cases of toxic hepatitis due to Tiga son have been reported previously [1], In our case, it is difficult to place the re sponsibility for the severe toxic hepatitis on either drug alone. It is known that Tigason is carried in the blood by albumin [6] as is 50-70% of the absorbed MTX [4], This sug gests that the hepatotoxic effects might be caused by a cumulation of the side effects of MTX alone due to its displacement from its albumin-binding site.…”

“…But Tigason may cause hepatotoxic side effects. This has been demonstrated by slightly elevated liver func tion tests, and also a few cases of manifest toxic hepatitis have been described [1,2,5].…”

A Randomized Trial of Etretinate (Tigason®) in Palmoplantar Pustulosis

“…This is in accordance with the findings of Christiansen et al [7] who, in psoriatic patients, found no significant dif ferences with regard to liver enzymes be tween etretinate and betamethasone. Dam age to the liver has, however, been reported after etretinate [8], but the real implications of these observations are still uncertain. Re sults from prospective controlled studies with liver biopsies are awaited with great in terest [9], Until then patients with known liver disease should not be treated with etret inate.…”

Etretinate (Tigason) Hepatitis in 2 Patients

“…A transient, slight elevation of one or sometimes more liver tests can be observed in patients on etretinate (Tigason, Ro 10-9359) therapy [1,6] and at least in some pa tients appears to be provoked by etretinate itself. Very mild damage of the parenchymal tissue in the liver biopsy of such a patient has been reported [9], A histologically con firmed hepatitis supposedly due to etretinate has been described in only 3 patients so far [ 1,8].…”

“…Very mild damage of the parenchymal tissue in the liver biopsy of such a patient has been reported [9], A histologically con firmed hepatitis supposedly due to etretinate has been described in only 3 patients so far [ 1,8].…”