It is well established that maternal exposure to certain drugs can result in fetal harm, including fetal death or other major adverse effects on fetal development. No causal associations have been established between paternal drug exposures and fetal harm in humans. Data from some preclinical studies, however, suggest that paternal drug exposures (particularly, exposures to genotoxic drugs) could cause fetal harm. This review describes mechanisms by which paternal drug exposure might lead to fetal harm; outlines results of relevant preclinical and clinical studies; notes the difficulty of detecting fetal harm related to paternal drug exposure (if it occurs), given the high background rates of spontaneous abortion and significant birth defects in the population; and suggests approaches that may mitigate the risk of fetal harm, when men participate in investigational drug studies.
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