Radiological abnormalities of the ileum associated with the use of clofazimine (Lamprene; B663) in the treatment of skin ulceration due to Mycobacterium ulcerans

Abstract

During the course of treatment with clofazimine (Lamprene; B663) for skin ulceration due to Mycobacterium ulcerans, a female patient aged 38 developed severe and persistent gastro-intestinal symptoms, with diarrhoea. These became most intense 9 months after starting the drug, during which period the dosage had been 100 mg three times daily. Barium meal examination of the gastro-intestinal tract showed striking abnormalities of the small bowel particularly ileum, consisting of alternating segments of constriction and dilatation, coarsening of the mucosal folds, and circumscribed 'polypoid' areas. Ileal loops were flexible, but painful on palpation and compression. On stopping clofazimine, the patient's abdominal symptoms and diarrhoea subsided rapidly. The skin ulceration soon healed completely. Fourteen months after stopping the drug, a repeat barium meal examination of the small bowel was normal. Although not confirmed by laparotomy or intestinal biopsy, no infective, parasitic or neoplastic cause was found for the intestinal symptoms and radiological abnormalities, and it is considered that they were closely associated with the ingestion of clofazimine. Other cases in the literature are reviewed in which it has been well established that clofazimine may crystallize out in human tissues, including the sub-mucosa of the bowel and intraabdominal lymph nodes. This drug, which is of great value in the treatment of leprosy, should be used in other conditions with caution, especially if alternative treatment is available. In leprosy, a dose of 100 mg three times weekly has been found effective and acceptable. Doses higher than this should only be used under exceptional circumstances and for short periods of time.