Inadequate evaluation of potential side effects of sildenafil in preterm stopped Dutch trial.

Recently a drug trial in the Netherlands in which the efficacy of oral sildenafil was compared to placebo in women bearing children with fetal growth restriction was stopped early because of very harmful side effects to the babies. There were quite some unwanted and unscientific aspects related to this study and the manner in which the side effects were communicated to the patients and the community. These have not gained the attention they ought to have. We therefore made an analysis of the basic problems which aims to prevent that the trust in medical research will be weakened.