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Eleven babies died as part of a study on drugs in the Netherlands. Their mothers received the active ingredient Sildenafil, which is marketed as Viagra. The doctors hoped to promote the growth of children in the uterus by increasing placental blood flow.
The study began in 2015, involving ten hospitals and 183 women. The participants were pregnant, the growth of their children was exceptional and of a worrying slowness. Originally, the study should have lasted until 2020 with a total of 250 patients. However, he has now been arrested.
By then, 93 of the 183 participants had been treated with sildenafil, according to the Academic Medical Center (AMC) of the University of Amsterdam. Of these, 17 women gave birth to babies with lung problems. Eleven children died after birth. According to the medical profession, this could be related to an increase in blood pressure in the lungs – and thus to a lack of oxygen. Another eight babies in this group were killed by other causes unrelated 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 now particularly important.
In the control group, where 90 women received a single placebo, three babies with lung problems were born. Although nine children died – the causes were not related to the study.
"Harming patients is the last thing you want"
Sildenafil has a vasodilating effect and is prescribed, for example, for erectile dysfunction. Dutch doctors were now hoping that the drug could also improve placental circulation. "We wanted to show that this is an effective way to promote baby growth," said study leader Wessel Ganzevoort in an interview with Dutch newspaper De Volkskrant. "But the opposite has happened, I'm shocked, hurting patients is the last thing you want."
According to Ganzevoort, they contacted doctors in Canada who are working on a similar study. "They have temporarily stopped their investigations."
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