Background

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.

Objective

To assess whether systemic dermatologic medications can cause infertility and teratogenicity when taken by men.

Methods

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.

Results

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.

Limitations

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.

Conclusions

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.

中文翻译：

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父亲暴露于全身皮肤科药物后的不育和致畸性：系统评价

背景

这项系统的评估以以前的美国食品和药物管理局（FDA）怀孕类别为基准，评估了父亲接触皮肤病药物的影响。

客观的

评估男性服用全身性皮肤病药物是否会引起不育和致畸性。

方法

确定了D类和X类皮肤病药物；进行了系统的文献回顾和FDA不良事件报告系统的回顾以及处方信息，以鉴定这些药物对男性生育能力和致畸性的影响。进行了次要搜索，以评估是否有其他因父系暴露而引起致畸性或不育的全身性皮肤科药物。

结果

共有13种药物符合纳入标准。在对文献进行系统的审查后，确定的1,032项研究中有19项被纳入研究。在评估的13种药物中，有10种评估了通过父亲暴露评估药物效果的研究，并在6种药物中发现了负面影响的证据。

局限性

我们没有针对符合入选标准的3种药物进行任何研究。提交给FDA不良事件报告系统的信息可能无法反映副作用的发生率。

结论

许多以前怀孕的D类和X类全身皮肤科药物也对男性生育能力有影响。在这一领域需要更多的研究和高质量的研究，特别是评估潜在致畸性的研究。