In the Netherlands, eleven babies have died as part of a drug study. Their mothers were given the active ingredient Sildenafil, which is marketed under the name Viagra. Physicians hoped to promote the growth of children in the womb by increasing the blood flow to the placenta.
The study had begun in 2015, ten hospitals and 183 women were involved so far. The participants were pregnant, their children's growth was exceptional and worryingly slow. Originally, the study should have lasted until 2020 with a total of 250 patients. Now it was stopped, however.
By then, 93 of the 183 participants had sildenafil treatment, according to the University of Amsterdam's Academic Medical Center (AMC). Of these, 17 women gave birth to babies with lung problems. Eleven children died after birth. According to the medical profession, this could be linked to increased blood pressure in the lungs - and thus to an undersupply of oxygen. Another eight babies in this group were killed by other causes not related to the drug study.
About 15 women treated with the drug have not yet given birth to their babies. Concern for the well-being of their children is especially great.
In the comparison group, where 90 women received only one placebo, three babies with lung problems were born. Although nine children died - the causes, however, were not related to the study.
"Damaging patients is the last thing you want"
Sildenafil has a vasodilating effect and is prescribed for erectile dysfunction, for example. The Dutch physicians now hoped that the drug could also provide for improved circulation of the placenta. "We wanted to show that this is an effective way to promote the growth of babies," said study leader Wessel Ganzevoort in an interview with the Dutch newspaper De Volkskrant. "But the opposite happened, I'm shocked, harming patients is the last thing you want."
According to Ganzevoort, they have contacted doctors in Canada who are working on a similar study. "They have temporarily stopped their investigations."