Dear Doctor Letter (Rote-Hand-Brief) on Sildenafil (Revatio® and Viagra®): Should not be used to treat intrauterine growth restriction
Active substance sildenafil
The STRIDER clinical trial, which was studying sildenafil for treating intrauterine growth restriction (IUGR), has been prematurely discontinued due to a higher incidence of persistent pulmonary hypertension of the newborn (PPHN) and overall neonatal death in the sildenafil arm of the study. Sildenafil is not approved for IUGR and should not be used for treating IUGR. Sildenafil should only be used in accordance with the current product information.