Severe cutaneous eruptions following the topical use of preparations containing bufexamac: Is it time to reconsider its registration in Australia?

Despite being a well-recognised cause of allergic contact dermatitis with an embargo in many countries around the world, bufexamac is available over the counter in topical preparations in Australia. We present a series of patients who developed severe cutaneous eruptions after the topical application of bufexamac containing preparations to highlight the potential risks of this medication, as well as advocate for the reconsideration of its registration by the Therapeutic Goods Administration in Australia.

Contact sensitization in patients with suspected cosmetic intolerance: results of the IVDK 2006-2011.

BACKGROUND: Ingredients of leave-on cosmetics and body care products may sensitize. However, not every case of cosmetic intolerance is due to contact sensitization. OBJECTIVE: To describe the frequency of contact sensitization due to cosmetics in a large clinic population, and a possible particular allergen pattern. METHODS: Retrospective analysis of data from the Information Network of Departments of Dermatology, 2006-2011. RESULTS: Of 69 487 patients tested, 'cosmetics, creams, sunscreens' was the only suspected allergen source category in 10 124 patients (14.6%). A final diagnosis 'allergic contact dermatitis' was stated in 2658 of these patients (26.3%).Compared to a control group, there were significantly more reactions to fragrance mixes I and II, balsam of Peru, methylchloroisothiazolinone/methylisothiazolinone (MCI/MI) and lanolin alcohols. No special pattern of fragrance sensitization could be identified. Among the preservatives, MI was by far the leading allergen, while sensitization to other widely used compounds like parabens or phenoxyethanol was rare. CONCLUSIONS: True allergic reactions to cosmetic ingredients are rarer than generally assumed. Limitation of exposure to MI in leave-on cosmetics and body care products is urgently needed.

Allergic contact dermatitis to topical preparations of bufexamac.

In Australia bufexamac is mainly used for pharmacist-initiated local treatment of various dermatoses. The European Medicines Agency's Committee for Medicinal Products for Human Use recently recommended that marketing authorisation for bufexamac-containing preparations be revoked throughout the European Union because of the risk of severe allergic contact dermatitis. We retrospectively reviewed the patch test database at the Skin and Cancer Foundation Inc. and identified 19 cases of positive reactions to bufexamac (5% petrolatum) from 451 people patch tested. The bufexamac reaction was deemed relevant to the presenting dermatitis in 13 of 19 (68%) patients. Bufexamac allergic contact dermatitis is under-reported in the English literature. We wish to emphasise the severity and the unusually polymorphic eruptions observed in some of the cases. Clinicians should consider the possibility of allergic contact dermatitis to bufexamac-containing preparations in all patients where there is a history of exposure, even if used for only a short time.

[Bufexamac-induced pigmented purpuric eruption]. / Kontaktallergie durch Bufexamac unter dem Bild einer chronischen Pigmentpurpura.

We report on a case of a bufexamac-induced allergic contact dermatitis with hematogenous dissemination presenting with the clinical and histological picture of a pigmented purpuric eruption. To our knowledge this is the first report on a bufexamac-induced pigmented purpuric dermatosis. It represents a further example of the clinical variety of cutaneous side-effects caused by bufexamac.

Efficacy of bufexamac cream versus betamethasone valerate cream in contact dermatitis: a double-blind trial.

A double-blind controlled study was carried out in 72 patients with atopic or contact dermatitis, who were randomly allocated to receive treatment with either 5% bufexamac, 0.1% betamethasone valerate or placebo creams. Patients applied the cream twice daily for 2 weeks. Assessments of the degree of severity of inflammation, induration, lichenification, crusts, scaling, and pruritus were made before and after treatment. The results showed that both active preparations were equally effective in improving the skin condition in the majority of the patients. In younger patients, however, the improvement with betamethasone valerate appeared to be somewhat better than that with bufexamac, particularly in relation to pruritus.

Double-blind trial comparing bufexamac infiltrations with triamcinolone acetonide infiltrations in patients with periarthritis of the shoulder.

A double-blind trial was carried out in 40 patients with an acute episode of periarthritis of the shoulder to compare the effectiveness and toleration of local infiltrations of bufexamac and triamcinolone acetonide. Patients received 1 or 2 local infiltrations with either 20 mg bufexamac or 40 mg triamcinolone acetonide. The results were evaluated by objective and subjective assessments of pain, loss of function, mobility, and by doctors' and patients' opinions of relief. There was a significant, comparable reduction in pain and discomfort in both groups after the first injection. Fourteen patients in each group required a second injection, with slightly more improvement in those receiving bufexamac. Local intolerance of the injections was noted in approximately 25% to 30% of the patients.

[Contact allergies caused by bufexamac]. / Kontaktallergien durch Bufexamac.

Between 1983 and 1987, there were 24 cases of contact allergy due to bufexamac seen at the Dermatological Hospital of the University of Göttingen. Of these patients, 20 were female und four male. It was noticeable, that the course of disease was particularly protracted and refractory: 16 of 22 patients were hospitalized with an average duration of inpatient treatment of 2.9 weeks. Seven patients had a generalized allergic contact dermatitis. Five patients had used topical preparations containing bufexamac for only one week or less. In 15 of 24 patients, further epidermal sensitization could be found. In all forms of eczematous diseases, especially in patients with chronic eczema, contact allergy to bufexamac should be considered, even if bufexamac preparations were used for only a short time.

[Severe contact dermatitis caused by Parfenac cream]. / Dermite de contact grave à la crème Parfenac.

Bufexamac is an anti-inflammatory agent used as topical treatment of various pruritic diseases. Since it was put on the market, this product has been blamed for the occurrence of contact dermatitis (eczema, urticaria) and, rarely, severe toxicodermia. We report a case of severe contact dermatitis developed after application of bufexamac (Parfenac) cream. Patch-tests performed two months after the acute phase were positive (+ + +) for both Parfenac cream and bufexamac.

Chronic urticaria due to Blastocystis hominis.

A 24-year-old woman had a 9-week history of second to third daily urticaria that began after an episode of contact urticaria to topical bufexamac. She was found to have an underlying gastrointestinal infection with Blastocystis hominis. This was thought to be clinically relevant as she had a history of mild chronic diarrhoea. After treatment of the Blastocystis hominis, her urticaria ceased. This could indicate the importance of performing stool microscopy and culture on all patients with chronic urticaria of unknown aetiology. The relationship of urticaria to intestinal parasites and the possibility that non-steroidal anti-inflammatory medications could act as cofactors that help precipitate an urticarial reaction is discussed.

[A common and insidious side-effect: allergic contact dermatitis caused by bufexamac used in the treatment of dermatitis. Results from the Information Network of Departments of Dermatology (IDVK)]. / Eine heimtückische und häufige Nebenwirkung: Kontaktallergien durch das Ekzemtherapeutikum Bufexamac. Ergebnisse des IVDK.

BACKGROUND AND OBJECTIVE: Bufexamac is a non-steroidal, anti-inflammatory drug used in the topical treatment of atopic dermatitis, stasis dermatitis and perianal eczema. The substance is known to cause severe allergic contact dermatitis (ACD) as an adverse effect (AE), which may be indistinguishable from the eczema which is to be treated. Hence the diagnosis of this AE is often considerably delayed. In order to estimate the quantitative importance of ACD to bufexamac, data of the Information Network of (German) Departments of Dermatology (IVDK) from July 1999 to December 2004 were analysed. PATIENTS AND METHODS: During the study period, 39,392 unselected patients from 40 German departments of the IVDK were patch tested with bufexamac (5 % pet). The results of the reading after 72 hours were analysed. The dichotomized patch test result was further assessed for possible risk factors from the patients' history and clinical diagnosis by Poisson regression analysis. RESULTS: In 560 of 39,392 patients contact allergy to bufexamac was diagnosed, i. e. 1.4 % (95 % confidence interval: 1.3 - 1.5), standardized for sex and age. The Poisson regression analysis revealed a significantly increased risk associated with the following factors: multiple sensitization, perianal eczema, underlying atopic dermatitis, leg dermatitis, female gender and residence in areas of Germany other than Eastern Germany. The latter observation can be explained by low prescription rates in Eastern Germany. CONCLUSION: Bufexamac is an important allergen. Extrapolating the frequency of 1.4 % in our data to the whole German population by the CE-DUR approach yields an estimate of about 6000 cases per year. In view of the high frequency of sensitization, the pitfalls in diagnosis, the severity of the course of disease and the lack of efficacy of this drug, the risk to benefit ratio is obviously critical.