RISK-FACTORS AND EPIDEMIOLOGIC ASPECTS OF ADVERSE DRUG-REACTIONS, ESPECIALLY CONSIDERING ALLERGIC AND PSEUDOALLERGIC PATHOMECHANISMS

Only drug surveillance systems which systematically collect events and /or ADRs as well as exposures to specific, individual drugs permit dir ect estimations of drug-induced disease or ADR frequencies. According to the pathomechanism of ADRs, we have defined three groups: pharmacol ogic, about 2/3 of the total, allergic or pseudoallergic, about 1/7 an d a special group of non-allergic kinds, about 1/5 partly already well described, partly not yet defined. Risk factors for ADRs determined b y multivariate statistics, to some degree independent of each other, s how the overwhelming importance of the number of drugs, followed by ad vanced age, reduced renal function and female sex. Special risk factor s revealed by the same methods are: A previous allergic or pseudoaller gic ADR increased the RR (Relative Risk) of an ADR in the first two we eks of hospital stay to 1.74 for allergic, to 1.61 for pharmacologic r eactions. For patients with an anamnestic bronchial asthma, the risk o f a bronchasthmatic reaction to a drug was 8 times higher than in non- asthmatics. The results of special studies of the literature reveal th at atopy without symptoms of bronchial asthma represents a recognized risk factor for ADRs in relation to narcotics, muscle relaxants and in travascular radiocontrast media. These findings support the recommenda tion that any adult patient with problems in the field of internal med icine be interrogated before the use of a new drug, on the question of previous ADRs or attacks of branchial asthma.