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Epidemiology of adverse cutaneous drug reactions. A prospective study in hospitalized patients.

Hernández-Salazar A, Rosales SP, Rangel-Frausto S, Criollo E, Archer-Dubon C, Orozco-Topete R

Dermatology Department, Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City, Mexico.

BACKGROUND: Drug reactions are commonly present in the skin; however, their frequency in our setting is unknown. METHODS: A 10-month prospective cohort study including all hospitalized patients was designed. Those with adverse cutaneous drug reactions (ACDR) were clinically identified. RESULTS: Thirty five drug reactions (prevalence of 0.7%) were seen among 4785 (2713 females, 2072 males) discharged patients. According to Begaud's imputability criteria, the reactions were most likely attributed to a drug in 4.87%, likely in 41.46% and possible in 53.65%. The most commonly seen dermatoses were morbilliform rash 51.2%, urticaria 12.2% and erythema multiforme 4.9%. Drugs most frequently associated with ACDR were amoxicillin clavulanate (8), amphotericin B (2) and metamizole (4). Expressed as risk by 1000 day-doses (Dd: the risk a patient has of developing an ACDR after receiving 1 day of treatment with the drug): amoxicillin clavulanate Dd 7.7, amphotericin B Dd 4.8 and metamizole Dd 3.7. Immunosuppressed patients were most frequently affected. Notably, patients with systemic lupus erythematosus (SLE) had a 4.68 higher risk (CI 95% 1.794-12.186 p <0.001) of developing an ACDR. AIDS patients showed a risk of 8.68 (CI 95% 2.18-33.19 p <0.001). Non-Hodgkin's lymphoma patients also had an increased risk of developing an ACDR. Six of the 35 identified cases were patients who had been hospitalized due to a severe drug reaction (1.3/1000 patients); one died from complications directly related to the ACDR, representing a 16.6% mortality rate among those admitted for an ACDR and 0.02% among the global mortality. CONCLUSIONS: We have a low prevalence of drug reactions compared to data reported in the literature. Pharmacovigilance with special attention to immunosuppressed SLE or AIDS patients is stressed.

Published 14 September 2006 in Arch Med Res, 37(7): 899-902.
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