Maternal paracetamol intake and fetal ductus arteriosus constriction/closure: comprehensive signal evaluation using the Austin Bradford Hill criteria
Hauben, Manfred; Bai, Stephen; Hung, Eric; Lobello, Kasia; Tressler, Charles; Zucal, Vincent P
PURPOSE/OBJECTIVE:) to justify risk communication. METHODS:, we synthesize and interpret within an Austin Bradford Hill criteria framework a comprehensive, cross-disciplinary set of published information and de novo analysis, including toxicology, epidemiology, clinical pharmacology, and clinical and quantitative pharmacovigilance analysis of spontaneous reports. RESULTS:, to the extent that it is reasonably possible that APAP may sometimes be at least a contributory cause of FCCDA. CONCLUSION/CONCLUSIONS:It is reasonably possible that APAP may sometimes be at least a contributory cause of FCCDA, and this should therefore be communicated to stakeholders. TRIAL REGISTRATION/BACKGROUND:CLINICALTRIALS. GOV REGISTRATION/UNASSIGNED:NOT APPLICABLE.
PMID: 33410971
ISSN: 1432-1041
CID: 4739172