HOW DOES CYSTITIS AFFECT A COMPARATIVE RISK PROFILE OF TIAPROFENIC ACID WITH OTHER NONSTEROIDAL ANTIINFLAMMATORY DRUGS - AN INTERNATIONAL STUDY BASED ON SPONTANEOUS REPORTS AND DRUG USAGE DATA

Series of well-documented case reports strongly suggest a causal assoc iation between tiaprofenic acid and a form of aseptic cystitis, which can cause serious and long-term morbidity if the drug is not withdrawn promptly. These findings are supported in the Australian and UK spont aneous reporting data-bases. Using sales data as the denominator, a co mparison of NSAIDs in the WHO drug monitoring data-base indicates that the reaction is specific to tiaprofenic acid and cannot be accounted for by changes in reporting patterns in certain countries or years. De layed recognition is an important feature of this reaction and possibl e reasons for this are discussed. Comparison of the risk profiles of s even NSAIDs indicated that tiaprofenic acid had the poorest risk profi le, compared with NSAIDs of similar efficacy, when cystitis reports we re included. The results suggest that combining spontaneous reports, c lassified according to severity, with sales data may enhance the abili ty of drug monitoring data-bases to contribute to risk benefit apprais als.