Perinatal deaths after sildenafil treatment of fetal growth restriction raise the issue of safety in randomised clinical trials

Pharmacoepidemiol Drug Saf. 2019 Apr;28(4):437-438. doi: 10.1002/pds.4740. Epub 2019 Mar 7.
No abstract available

MeSH terms

  • Drug Interactions
  • Female
  • Fetal Growth Retardation / drug therapy*
  • Humans
  • Infant, Newborn
  • Infant, Small for Gestational Age
  • Multicenter Studies as Topic / standards
  • Patient Safety / standards*
  • Perinatal Death*
  • Phosphodiesterase 5 Inhibitors / administration & dosage
  • Phosphodiesterase 5 Inhibitors / adverse effects*
  • Phosphodiesterase 5 Inhibitors / pharmacokinetics
  • Pregnancy
  • Randomized Controlled Trials as Topic / standards
  • Research Design / standards
  • Sildenafil Citrate / administration & dosage
  • Sildenafil Citrate / adverse effects*
  • Sildenafil Citrate / pharmacokinetics
  • Vasodilator Agents / administration & dosage
  • Vasodilator Agents / pharmacokinetics

Substances

  • Phosphodiesterase 5 Inhibitors
  • Vasodilator Agents
  • Sildenafil Citrate