Dutch authorities terminated a major drug trial in the Netherlands last week after women who were given Viagra to increase the growth of their unborn child as part of the exercise face an anxious wait after the deaths of 11 babies, The Guardian reported on Tuesday.
The research, carried out at 10 hospitals across the Netherlands, involved women whose placentas had been underperforming taking sildenafil, a medication sold under the brand name Viagra. Viagra, which dilates the blood vessels, is used for erectile dysfunction in men and is prescribed for people with high blood pressure. The hope, backed up by experimental research on rats, had been that the drug would encourage a better flow of blood through the placenta, promoting the growth of the child.
The trial was terminated last week when an independent committee overseeing the research discovered that more babies than expected were being born with lung problems. The research began in 2015 and was due to run until 2020, with the participation of 350 patients.
The pregnant women taking part in the trial all had unborn babies whose growth had been severely limited in the womb. The children’s prognosis, given a lack of available therapy, was regarded as being poor as a result.
In total, 93 women were given the drug as part of the trial, led by Amsterdam University Medical Centre. Seventeen babies developed lung problems, and 11 have since died. Between 10 and 15 women are waiting to find out if their child has been affected.
It is feared the drug caused high blood pressure in the lungs, leading to the babies receiving too little oxygen. There is nothing to suggest the trial was mishandled, the report said.
A spokesman for Amsterdam UMC said it believed the trial had been conducted properly, but would expect an external investigation to be launched.
The hospital said in a statement: “An interim analysis by Amsterdam UMC, location AMC, showed that sildenafil may be detrimental to the baby after birth. The chance of a disease of the blood vessels of the lungs appears to be greater and the chance of death after birth seems to have increased.
“The researchers found no positive effect for the children on other outcomes. All adverse effects occurred after birth … Based on these findings, the study stopped immediately.”
