Delayed reaction due to trimebutine

Abstract

Rationale A 40-year-old non-atopic woman presented with generalized pruritic and erythematous hives without angioedema, seven days after initiation therapy with Nolotil® and Proctolog® cream for hemorrhoids. Nolotil® and Proctolog® cream were stopped and the patient successfully treated with intramuscular corticosteroid. Methods Patch test were performed on the upper back with the European Standard Series, Proctolog® cream and its components (trimebutine and ruscogenin). Oral provocation test were realized with Nolotil® and trimebutine. Results European Standard Series were all negative, but the patch tests with Proctolog® cream and trimebutine were positive at 48 (++) and 96 hours (+++) Twenty controls were entirely negative. 72 hours after oral provocation test with trimebutine the patient presented generalized urticaria. Oral provocation test with Nolotil® was negative. Conclusions Trimebutine [2-dimethylamino-2-phenylbutyl 3,4,5-trimethoxybenzoic acid], is an antispasmodic used orally to treat functional bowel disorders, and rectally and topically for anal fissures and hemorrhoids. The first adverse effects from topical application were reported by Maffioli et al. in 1975 and Chebanon in 1976, both reports being erythema and/or burning. There is only one article published in the literature about contact allergic dermatitis caused by trimebutine. To our knowledge, delayed-type hypersensitivity urticaria from trimebutine has not previously been reported. The patch test has been demonstrated as a good way for the diagnostic of a type IV hypersensitivity reaction to trimebutine.