OBJECTIVES: The Spanish Agency of Medicines and Healthcare Products (SAMHP) makes regulatory decisions concerning pharmacovigilance. Here, we analyse the impact of actions related to safety adopted by the SAMHP on drug consumption financed by the Spanish National Health System (NHS), over the period 1990-2004. METHODS: A retrospective analysis of the consumption was made, selecting drugs which were eventually withdrawn from the market. Consumption data was provided by the Ministry of Health and Consume (MHC) database and expressed as number of prescriptions. Drugs selected were classified according to type of Adverse Drug Reaction (ADR), Anatomic Therapeutic-Chemical Classification (ATC) and degree of therapeutic innovation at the moment of authorisation, according to the MHC. RESULTS: Fourteen drugs were selected for the purpose of this study, and none of these were categorised as "an exceptional therapeutic novelty". The most common ADRs concerned severe liver (7/14) or heart (5/7) toxicity. At least 8 of the 14 drugs were associated with one safety action before being withdrawn. This was either a product labelling modification (astemizole, droxicam, nimesulide, nefazodone, cerivastatine, trovafloxacine and rofecoxib) or classification as hospitalary diagnostic (cisapride). Rofecoxib was the only one with two actions. A high level of consumption and in a very short time from authorisation until the first safety action (between one to three years) was found in nimesulide, cerivastatine and rofecoxib. In the rest of the drugs, the only action was the withdrawn. This happened after one year post-authorisation (tolcapone, sertindol and grepafloxacine) or in the case of ebrotidine, two years. CONCLUSIONS: The drugs withdrawn after one or two years from their authorisation would seem reasonable not have been financed by NHS. In all drugs, the first safety action resulted in a significant decrease in consumption. In some of these cases, manufacturers requested to SAMHP drug to be withdrawn.