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This editorial refers to ‘Frequency of drug-induced valvular heart disease in patients previously exposed to benfluorex: a multicentre prospective study’[†][1], by C. Tribouilloy et al. , on page 3580 Data from epidemiological studies, and a single randomized trial, have plausibly suggested that a variety of amphetamine-related molecules can cause valvular morphological lesions and variable degrees of valvular dysfunction.1–10 Though a causal relationship has not been unequivocally proven, cellular mechanisms have been defined that may account for such a relationship.11,12 However, early in the experience with the phentermine–fenfluoramine combination that sensitized the medical community to such problems,1 the frequency of valve involvement probably was markedly overstated. Indeed, at the height of the concern, when several very small series suggested that the majority of exposed patients developed valve disease, five patients (as large as some of the published series) were referred to me after moderately long exposure to seek evidence of valve disease; none was apparent in any. Importantly, the involved drugs all were approved for specific benefits, e.g. weight reduction for morbidly obese persons who might suffer from orthopaedic, psychological, cardiovascular, and other debilities in part because of their body weight, and diabetes control for patients in whom glucose metabolic abnormalities could have several unwanted and potentially preventable consequences. In all such situations, the appropriateness of the therapies must be determined on the basis of a judgement of putative benefits vs. putative risks. Since the benefits and the risks of the amphetamine-related therapies are intrinsically different, the relationship between benefit and risk is impossible to quantify rigorously and must be based on the judgement of experienced observers. Therefore, it is essential to quantify, as precisely as possible, the benefits and the risks. Benefits often are reasonably quantified by randomized, appropriately controlled trials enabling comparison of … [1]: #fn-2

Drug-induced valve disease and considerations of benefit versus risk