Germany - The Drug Commission of the German Medical Profession has issued a cautionary statement concerning bufexamac, an anti-inflammatory agent used mainly for topical use. Initially, bufexamac was indicated for the relief of skin inflammation due to endogenous eczema (neurodermatitis) and chronic eczema. Subsequently, bufexemac was indicated as a substitute for glucocorticoid therapy to treat atopic dermatitis, but it was also used for the treatment of eczema of various types such as congestion dermatitis in Status varicosus, perianal eczema due to haemorrhoids, and undetermined dermatoses.

It has been known for some time that bufexamac can provoke contact dermatitis. Since 1987, 25 cases have been published in the literature. Such cases of contact eczema have often persisted for several months, sometimes because the symptoms were erroneously attributed to eczema. Since the allergic potential of bufexamac was often not suspected, its extent was not recognized since these allergies were always considered as rare. In recent years, not only spontaneous reports but also the results of epidemiological studies have given an indication of the number of cases of allergy due to bufexamac.

Data collected from 14 dermatological clinics (showing a rate of 1.7% per 8,163 patients) suggest that bufexamac allergy has been very much underrated and under-reported and that the real figure could be some 10 200 cases a year, or in the worst case, from 28 333 to 68 000 cases.

It has been concluded that bufexamac can itself provoke contact eczema. Since this substance is indicated for skin diseases which are deceptively similar to the adverse reactions there is a real danger that bufexamac allergy may not be recognized. For indications such as congestion dermatitis or perianal eczema, available therapy should be used that is indicated for the causative underlying affliction. Before making a critical assessment of bufexamac-containing topical products, alternative eczema therapies should be considered. In therapy-resistant eczemas which have been treated with bufexamac, the causative role of the active pathogen may also be important.

Reference: Pharmazeutische Zeitung, 145(49): 4185 (2000).