The opinions expressed in this publication represent the opinions ofthe contributors and do not reflect the oficial p d i g of P j z n lnc or the institutions with which the authors are affiliated.Drug Information J m d .

The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

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Potential risk factors for bladder cancer were studied in a series of 76 male and 76 female bladder cancer cases and 238 male and 254 female controls who reported never having smoked. Risk factors included usual occupation, smoking by the spouse, sidestream smoke exposure at home and at work and in transportation, coffee drinking (caffeinated and decaffeinated), artificial sweetener use, body mass index, and a history of diabetes and high blood pressure. No association was found with spouse's smoking or reported sidestream smoke exposure, coffee drinking, artificial sweetener use, or a number of other variables; however, there was some indication that several occupations were overrepresented in the cases. A positive association was found with snuff use in women, but the numbers were small (three cases and one control). Restriction of the study to lifetime nonsmokers permitted the assessment of potential risk factors in the absence of potential confounding and interactive effects of smoking. The study had adequate statistical power to detect moderately small elevated risks due to the main factors examined.

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