id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2026-P-5454-0009,FDA,FDA-2026-P-5454,"References 7 - Smarr, M. M., et al. (2016). Urinary paracetamol and time-to-pregnancy. Human Reproduction, 31(9), 2119-2127. URL: https://pubmed.ncbi.nlm.nih.gov/27412248/",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:42:39Z,,0,0,09000064b92d5011
FDA-2026-P-5454-0014,FDA,FDA-2026-P-5454,"Reference 12 - de Araújo-Ramos, A. T., et al. (2026). Differential disruption of gonadal development by DEHP and paracetamol in male and female Wistar rats. Reproductive Toxicology, 141, 109183. URL: https://doi.org/10.1016/j.reprotox.2026.109183",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:42:56Z,,0,0,09000064b92d5031
FDA-2026-P-5454-0015,FDA,FDA-2026-P-5454,"Reference 13 - Laursen, T. Q., et al. (2024). Maternal intake of paracetamol during pregnancy and biomarkers of male fecundity in young adult sons. Reproductive Toxicology, 127, 108626. URL: https://doi.org/10.1016/j.reprotox.2024.108626",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:43:00Z,,0,0,09000064b92d5032
FDA-2026-P-5454-0002,FDA,FDA-2026-P-5454,Acknowledgment Letter from FDA DMB to Americans for Scientific Integrity,Other,Acknowledgement Letter/Receipt,2026-05-14T04:00:00Z,2026,5,2026-05-14T04:00:00Z,,2026-05-14T17:41:43Z,,0,0,09000064b92d4fe9
FDA-2026-P-5454-0001,FDA,FDA-2026-P-5454,Citizen Petition from Americans for Scientific Integrity,Other,Citizen Petition,2026-05-14T04:00:00Z,2026,5,2026-05-14T04:00:00Z,,2026-05-14T17:41:38Z,,1,0,09000064b92d4fe7
FDA-2026-P-5454-0011,FDA,FDA-2026-P-5454,"Reference 9 - Carlsen, L. N., et al. (2024). Overuse of analgesics can affect the fertility biomarker Anti-Müllerian Hormone in females. A translational study. Cephalalgia, 44(11). URL: https://doi.org/10.1177/03331024241290530",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:42:46Z,,0,0,09000064b92d5013
FDA-2026-P-5454-0004,FDA,FDA-2026-P-5454,"References 2 - Fisher, B. G., et al. (2016). Prenatal paracetamol exposure is associated with shorter anogenital distance in male infants. Human Reproduction, 31(11), 2642-2650. URL: https://pubmed.ncbi.nlm.nih.gov/27609981/",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:41:58Z,,0,0,09000064b92d500c
FDA-2026-P-5454-0013,FDA,FDA-2026-P-5454,"Reference 11 - Wu, T., et al. (2024). Prenatal acetaminophen exposure and the developing ovary: time, dose, and course consequences for fetal mice. Food and Chemical Toxicology, 189, 114679. URL: https://doi.org/10.1016/j.fct.2024.114679",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:42:53Z,,0,0,09000064b92d5030
FDA-2026-P-5454-0017,FDA,FDA-2026-P-5454,"Reference 15 - Lee, C. Y., et al. (2023). Effects of acetaminophen on reproductive activities in male golden hamsters. Development & Reproduction, 27(1), 25-37. URL: https://doi.org/10.12717/DR.2023.27.1.25",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:43:26Z,,0,0,09000064b92d5034
FDA-2026-P-5454-0021,FDA,FDA-2026-P-5454,"Reference 19 - Eletri, L., et al. (2026). Association between in utero exposure to acetaminophen and external genital tract malformations in boys and girls: a systematic review and meta-analysis. Human Reproduction, 41(3), 427-442. URL: https://doi.org/10.1093/humrep/deaf253",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:43:53Z,,0,0,09000064b92d5038
FDA-2026-P-5454-0003,FDA,FDA-2026-P-5454,"References 1 - Ernstsen, C., et al. (2026). Prenatal paracetamol modulates sexually dimorphic behaviour and steroidogenesis in adult male and female mice. Reproduction, 171(2). URL: https://doi.org/10.1093/reprod/xaag007",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:41:54Z,,0,0,09000064b92d500b
FDA-2026-P-5454-0006,FDA,FDA-2026-P-5454,"References 4 - Guzmán-Montemayor, A. J., et al. (2026). Prenatal, but not neonatal, paracetamol exposure disrupts neuroendocrine regulation of stress and emotional behavior in adult male rats. Physiology & Behavior, 308, 115261. URL: https://doi.org/10.1016/j.physbeh.2026.115261",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:42:16Z,,0,0,09000064b92d500e
FDA-2026-P-5454-0007,FDA,FDA-2026-P-5454,"References 5 - Górawski, F., et al. (2026). Sex-dependent effects of early-life paracetamol exposure on behavior and monoamines in the rat central nervous system. Chemico-Biological Interactions, 427, 111937. URL: https://doi.org/10.1016/j.cbi.2026.111937",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:42:31Z,,0,0,09000064b92d500f
FDA-2026-P-5454-0005,FDA,FDA-2026-P-5454,"Reference 3 - Lind, D. V., et al. (2017). Maternal use of mild analgesics during pregnancy associated with reduced anogenital distance in sons. Human Reproduction, 32(1), 149-155. URL: https://pubmed.ncbi.nlm.nih.gov/27852690/",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:42:12Z,,0,0,09000064b92d500d
FDA-2026-P-5454-0018,FDA,FDA-2026-P-5454,"Reference 16 - Xu, M., et al. (2024). Association of acetaminophen use with perinatal outcomes among pregnant women: a retrospective cohort study with propensity score matching. BMC Pregnancy and Childbirth, 24, 268. URL: https://doi.org/10.1186/s12884-024-06480-5",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:43:29Z,,0,0,09000064b92d5035
FDA-2026-P-5454-0023,FDA,FDA-2026-P-5454,Reference 21 - OFIRMEV (acetaminophen) Injection Package Insert. (2018). Mallinckrodt Hospital Products Inc.,Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:44:02Z,,0,0,09000064b92d503a
FDA-2026-P-5454-0020,FDA,FDA-2026-P-5454,"Reference 18 - Rehfeld, A., et al. (2022). Human sperm cells can form paracetamol metabolite AM404 that directly interferes with sperm calcium signalling and function through a CatSper-dependent mechanism. Human Reproduction, 37(5), 922-935. URL: https://doi.org/10.1093/humrep/deac042",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:43:48Z,,0,0,09000064b92d5037
FDA-2026-P-5454-0022,FDA,FDA-2026-P-5454,"Reference 20 - Kougias, D. G., et al. (2025). A quantitative weight-of-evidence review of preclinical studies examining the potential developmental and reproductive toxicity of acetaminophen. Critical Reviews in Toxicology, 55(2), 179-226. URL: https://doi.org/10.1080/10408444.2024.2446471",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:43:58Z,,0,0,09000064b92d5039
FDA-2026-P-5454-0010,FDA,FDA-2026-P-5454,"References 8 - Nielsen, B. S., et al. (2025). Paracetamol disrupts early embryogenesis by cell cycle inhibition. Human Reproduction, 40(10), 1860-1876. URL: https://doi.org/10.1093/humrep/deaf116",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:42:42Z,,0,0,09000064b92d5012
FDA-2026-P-5454-0019,FDA,FDA-2026-P-5454,"Reference 17 - Zafeiri, A., et al. (2022). Maternal over-the-counter analgesics use during pregnancy and adverse perinatal outcomes: cohort study of 151,141 singleton pregnancies. BMJ Open, 12(5), e048092. URL: https://doi.org/10.1136/bmjopen-2020-048092",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:43:32Z,,0,0,09000064b92d5036
FDA-2026-P-5454-0008,FDA,FDA-2026-P-5454,"References 6 - Lecante, L. L., et al. (2022). Acetaminophen interferes with the first trimester human fetal ovary development in an ex vivo model. Journal of Clinical Endocrinology & Metabolism, 107(6), 1647-1661. URL: https://pubmed.ncbi.nlm.nih.gov/35147701/",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:42:35Z,,0,0,09000064b92d5010
FDA-2026-P-5454-0012,FDA,FDA-2026-P-5454,"Reference 10 - Liu, F., et al. (2024). Maternal administration of acetaminophen affects meiosis through its metabolite NAPQI targeting SIRT7 in fetal oocytes. Antioxidants & Redox Signaling, 41, 93-109. URL: https://doi.org/10.1089/ars.2023.0270",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:42:50Z,,0,0,09000064b92d502f
FDA-2026-P-5454-0016,FDA,FDA-2026-P-5454,"Reference 14 - Andreasen, S. M., et al. (2025). Maternal urinary paracetamol concentrations and self-reported paracetamol use in mid-gestation: association to reduced anogenital distance in offspring from infancy to 9 years. Reproductive Toxicology, 135, 108946. URL: https://pubmed.ncbi.nlm.nih.gov/40374128/",Supporting & Related Material,Background Material,2026-05-14T04:00:00Z,2026,5,,,2026-05-14T17:43:22Z,,0,0,09000064b92d5033