[Combination analgesics consisting of paracetamol plus acetylsalicylic acid: benefits and risks.].

According to the German Drug Law of 1976 the present status of scientific knowledge regarding the benefit/risk-ratio of combination analgesics was reevaluated and is summarized taking the fixed combination of paracetamol plus acetylsalicylic acid as an example. The extensive discussion of the responsible committee for reevaluation of drugs B-3 (Neurology/Psychiatry) at the German Federal Institute of Health (Bundesgesundheitsamt) led to the following results as viewed by the involved members: - the fixed combination has its pharmacological rationale (secure detoxification, even with high single doses; (over)additive analgesic effect in experimental models. - the benefit of the fixed combination is given by a potentially lower liver toxicity as proven with experimental models and by an (over)additive efficacy in cancer pain or headache. - combination-specific risks surpassing the ones of the single substances are not recognizable. This holds particularly true also for the risk of analgesic nephropathy being presented elsewhere [19]. Even though the clinical efficacy has been proven only in few specific studies the evaluation of the benefit/risk-ratio appears to be positive regarding the not recognizable combination-specific risks. The combination is recommended for acute use.