Abstract
Adverse drug effects are often detected in phase-II and phase-III studies, and they are frequently explainable from the mode of action of the drug tested. In addition, there are “idiosyncratic” adverse reactions, which may not be deduced from the pharmacological effects of the drug. The incidence may be below 1 in 1000, and these effects will not be detected in phase-II and phase-III studies. The population at risk may not be distributed evenly across the general population, e.g. because of genetic heterogeneity (Goodman Gilman 2005). The spontaneous reporting of adverse reactions is thus an effective way to shed light on potential adverse reactions. Most national and supranational authorities in the Western world have introduced a reporting system for adverse drug events.
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(2008). Adverse Drug Effects. In: Drugs Compromising Male Sexual Health. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-69862-3_4
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DOI: https://doi.org/10.1007/978-3-540-69862-3_4
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