WHO Drug Information Vol. 15, No. 1, 2001
(2001; 56 pages) View the PDF document
Table of Contents
Open this folder and view contentsQuality Assurance Issues
Open this folder and view contentsPersonal Perspectives
Open this folder and view contentsCurrent Topics
Close this folderRegulatory and Safety Matters
View the documentNew formulation of DTP vaccine
View the documentBupropion safety reminder
View the documentPropofol: reactions to long-term high doses
View the documentPropofol: not for paediatric use
View the documentLeflunomide: hepatic reactions
View the documentRapacuronium bromide voluntarily withdrawn
View the documentLevacetylmethadol withdrawn
View the documentLevacetylmethadol: labelling changes
View the documentIsotretinoin and depression
View the documentNew glucose test for adult diabetics
View the documentAnti-inflammatory analgesics: hepatic reactions
View the documentGentamicin ear drops: toxicity
View the documentTetracycline and benign intracranial hypertension
View the documentErgotamine and erythromycin interaction
View the documentCelecoxib and warfarin interaction
View the documentCerivastatin: rare effect of rhabdomyolysis
View the documentSSRIs and increased ocular pressure
View the documentAmfepramone: new cases of primary pulmonary hypertension
View the documentBufexamac and contact eczema
View the documentDroperidol: prolongation of the QT interval
View the documentMofezolac: revised data sheet
View the documentMonoethanolamine oleate: revised data sheet
View the documentRivastigmine: revised product information
View the documentSarpogrelate: revised data sheet
Open this folder and view contentsATC/DDD Classification

Bufexamac and contact eczema

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).

to previous section
to next section
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: December 6, 2017