title: FDA-approved medications that impair human spermatogenesis.
abstract: We herein provide an overview of the single-ingredient U.S. Food and Drug Administration (FDA)-approved drugs that affect human spermatogenesis, potentially resulting in a negative impact on male fertility. To provide this information, we performed an in-depth search of DailyMed, the official website for FDA-approved drug labels. Not surprisingly, hormone-based agents were found to be the drugs most likely to affect human spermatogenesis. The next category of drugs most likely to have effects on spermatogenesis was the antineoplastic agents. Interestingly, the DailyMed labels indicated that several anti-inflammatory drugs affect spermatogenesis, which is not supported by the peer-reviewed literature. Overall, there were a total of 65 labels for drugs of various classes that showed that they have the potential to affect human sperm production and maturation. We identified several drugs indicated to be spermatotoxic in the drug labels that were not reported in the peer-reviewed literature. However, the details about the effects of these drugs on human spermatogenesis are largely lacking, the mechanisms are often unknown, and the clinical impact of many of the findings is currently unclear. Therefore, additional work is needed at both the basic research level and during clinical trials and post-marketing surveillance to fill the gaps in the current knowledge. The present findings will be of interest to physicians and pharmacists, researchers, and those involved in drug development and health care policy.
authors: Department of Reproductive Medicine, Nantong Maternity and Child Health Hospital, Nantong, China.
authors: Jiayi
authors: J
authors: Ding
authors: Department of Andrology, Jinling Hospital/Nanjing General Hospital Affiliated with Nanjing University School of Medicine, Nanjing, China.
authors: Xuejun
authors: X
authors: Shang
authors: Department of Reproductive Medicine, Nantong Maternity and Child Health Hospital, Nantong, China.
authors: Zhanhu
authors: Z
authors: Zhang
authors: Department of Reproductive Medicine, Nantong Maternity and Child Health Hospital, Nantong, China.
authors: Hua
authors: H
authors: Jing
authors: Department of Reproductive Medicine, Nantong Maternity and Child Health Hospital, Nantong, China.
authors: Jun
authors: J
authors: Shao
authors: Department of Reproductive Medicine, Nantong Maternity and Child Health Hospital, Nantong, China.
authors: Qianqian
authors: Q
authors: Fei
authors: CLIA Laboratory Director (various laboratories), Birmingham, AL, USA.
authors: Elizabeth R
authors: ER
authors: Rayburn
authors: Department of Reproductive Medicine, Nantong Maternity and Child Health Hospital, Nantong, China.
authors: Haibo
authors: H
authors: Li
mesh_terms: D000818:Animals; D017277:Drug Approval; D004348:Drug Labeling; D005298:Fertility / Q000187:drug effects*; D006801:Humans; D007248:Infertility, Male / Q000139:chemically induced* / Q000378:metabolism / Q000473:pathology / Q000503:physiopathology; D008297:Male; D018570:Risk Assessment; D012307:Risk Factors; D013091:Spermatogenesis / Q000187:drug effects*; D013094:Spermatozoa / Q000187:drug effects* / Q000378:metabolism / Q000473:pathology; D014481:United States; D014486:United States Food and Drug Administration
keywords: FDA labels; dailyMed; drug development; prescription drugs; spermatogenesis