Ronald O. Perelman Department of Dermatology, New York University School of Medicine, New York, New York.
Ronald O. Perelman Department of Dermatology, New York University School of Medicine, New York, New York; Department of Dermatologic Surgery, Mount Sinai Beth Israel, New York, New York.
J Am Acad Dermatol. 2019 Apr;80(4):957-969. doi: 10.1016/j.jaad.2018.09.031. Epub 2018 Oct 2.
This systematic review assesses effects of paternal exposure to dermatologic medications by using the former US Food and Drug Administration (FDA) pregnancy categories as a benchmark.
To assess whether systemic dermatologic medications can cause infertility and teratogenicity when taken by men.
Categories D and X dermatologic medications were identified; a systematic review of the literature and reviews of the FDA Adverse Events Reporting System and prescribing information were performed to identify the effects of these medications on male fertility and teratogenicity. A secondary search was performed to assess for other systemic dermatologic medications causing teratogenicity or infertility following paternal exposure.
A total of 13 medications met the inclusion criteria. Of 1,032 studies identified, 19 were included after a systematic review of the literature. Studies evaluating medication effects with paternal exposure were identified for 10 of the 13 evaluated medications, and evidence of a negative effect was identified for 6 medications.
We did not encounter any studies for 3 medications that met the inclusion criteria. Information submitted to the FDA Adverse Events Reporting System may not reflect the incidence of side effects.
Many former pregnancy category D and X systemic dermatologic medications also have effects on male fertility. More research and better-quality studies are required in this area, particularly studies assessing potential teratogenicity.
本系统评价以美国食品药品监督管理局（FDA）妊娠药物分类为基准，评估父亲暴露于皮肤科药物的影响。
评估男性使用全身皮肤科药物是否会导致不孕和致畸。
确定 D 类和 X 类皮肤科药物；对文献进行系统评价，对 FDA 不良事件报告系统和处方信息进行综述，以确定这些药物对男性生育力和致畸性的影响。进行二次检索以评估其他全身皮肤科药物在父亲暴露后是否会导致致畸或不孕。
共有 13 种药物符合纳入标准。在确定的 1,032 项研究中，经过系统评价后纳入了 19 项研究。在所评估的 13 种药物中有 10 种药物评估了药物对父亲暴露的影响，有 6 种药物有证据表明存在负面影响。
我们没有遇到符合纳入标准的 3 种药物的研究。向 FDA 不良事件报告系统提交的信息可能无法反映副作用的发生率。
许多以前的妊娠药物分类 D 类和 X 类全身性皮肤科药物也会影响男性生育力。这方面需要更多的研究和更高质量的研究，特别是评估潜在致畸性的研究。
