Abstract

Data on the epidemiology of adverse drug reactions (ADR), especially allergic drug reactions, in children are rare. The reported prevalence of ADR in pediatric populations varies a lot, depending on type of the study and the country where the data were collected. In order to assess the prevalence of ADR and allergic drug reactions in a population of German children, we conducted a study in a German pediatric university hospital. A questionnaire concerning occurrence and character of ADR was distributed to all parents presenting their children in the hospital for planned admissions or in the emergency department from May 2004 to November 2004. Additional telephone interviews were conducted to specify the reported symptoms in ambiguous cases. One thousand four hundred forty-seven questionnaires were collected. The reported life-time prevalence of ADR according to the information given by the parents was 7.5% (108/1447). Six of the reactions were severe, three children had experienced anaphylactic reactions. In 4.2% (61/1447), the history was suspicious for a potential allergic mechanism because of an immediate or late phase cutaneous drug reaction. In this group, the suspected drugs were antibiotics in 85% (32.7% aminopenicillins, 29.5% other penicillins, 11.5% cefaclor, 8.2% macrolides and 18% others), antiphlogistic and respiratory drugs in 4.9% each and vaccines and contrast media in 3.3% each. There was a higher percentage of children under the age of four suffering from ADR. This trend was not significant when analyzing only the allergic reactions. Forty-four percent of the parents stated, their children suffer from drug allergy, although a clear non-allergic reaction was described. Both, ADR and allergic drug reactions are frequent phenomena in children. It is important to monitor drug therapy for any adverse reaction in order to inform the parents about the character of the adverse reaction, the necessary consequences and to initiate further diagnostic procedures.

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