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Cefaclor-associated serum sickness-like disease: eight cases and review of the literature.

OBJECTIVE: To describe the clinical features of serum sickness-like diseases (SSLD) in cefaclor-treated patients.

DESIGN: Analysis of a case series spontaneously reported to Lyons Pharmacovigilance Center.

SETTING: General and hospital practitioners and the French Network of Regional Pharmacovigilance Centers (FNRPC).

PATIENTS: All reported cases with a possible causative relationship between cefaclor treatment and SSLD.

MAIN RESULTS: Eight cases of SSLD following cefaclor treatment are described. The clinical features included cutaneous reactions, arthralgias, and moderate hyperthermia. In 50 percent of the patients, hospitalization was required because of incapacitating symptoms. The outcome was benign in all cases following discontinuation of the offending drug. All eight cases were reported in children under five years of age. Among 137 cefaclor-associated drug reactions collected by FNRPC, 27 cases of SSLD have been reported; 23 of these patients were younger than five years of age. A literature survey confirmed the higher reporting of SSLD in children with cefaclor compared with other antibiotics and suggested an incidence of 0.024-0.2 percent of SSLD per drug course of cefaclor.

CONCLUSIONS: The case reports and epidemiologic studies confirmed the presumed role of age (patients under five years of age) in cefaclor-induced SSLD and the benign outcome despite severe clinical presentations in some reports.

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