FDA-approved medications that impair human spermatogenesis

// Jiayi Ding 1,* , Xuejun Shang 2,* , Zhanhu Zhang 1 , Hua Jing 1 , Jun Shao 1 , Qianqian Fei 1 , Elizabeth R. Rayburn 3 and Haibo Li 1 1 Department of Reproductive Medicine, Nantong Maternity and Child Health Hospital, Nantong, China 2 Department of Andrology, Jinling Hospital/Nanjing General Hospital Affiliated with Nanjing University School of Medicine, Nanjing, China 3 CLIA Laboratory Director (various laboratories), Birmingham, AL, USA * These authors have contributed equally to the manuscript Correspondence to: Elizabeth R. Rayburn, email: // Haibo Li, email: // Keywords : spermatogenesis; prescription drugs; FDA labels; dailyMed; drug development Received : August 15, 2016 Accepted : October 17, 2016 Published : October 27, 2016 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.