Babies Die After Mums Given Viagra In Dutch Trial

Babies Die After Mums Given Viagra In Dutch Trial

Babies Die After Mums Given Viagra In Dutch Trial

By Jop de VriezeJul.

Senior researcher Wessel Ganzevoort, who is based at the AMC teaching hospital in Amsterdam, told Hart van Nederland it was focusing on supporting the parents.

A sildenafil in pregnancy trial has been urgently stopped after 11 newborn babies died. A data and safety monitoring committee, however, had looked at the unblinded evidence halfway through the study and wanted to talk.

A similar study in the United Kingdom testing the effectiveness of sildenafil found no benefit to pregnant mothers, CNN reports, but did not show any of the adverse effects of the Dutch trial.

The researchers informed the women that common side-effects were dizziness, rosy cheeks, headaches and an increased sexual appetite.

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Three of the women in the control group (n=90) also had babies who developed the same lung problems, but none have died from any condition which could be related to sildenafil.

The research, carried out at 10 hospitals, involved giving the women - chosen because their placentas had been under performing - the drug sildenafil, commonly sold under the brand name Viagra.

"We have already notified Canadian researchers who are conducting a similar study", Ganzevoort said. The study was started in 2015 and was due to run until 2020, with 350 patients participating. Some were then born with lung conditions. Six babies were born with the lung disorder and survived.

The Dutch trial was created to investigate whether Viagra was useful in promoting the growth of severely underdeveloped babies in the womb. The doctors decided that the child would be better to stay and develop inside the mother.

In total, 93 women were given sildenafil and 90 were given a dummy drug or placebo. Yet it is not approved for such use in pregnant women by any regulatory body, so physicians have been using it in a so-called off-label manner.

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A second trial with the same drug in Canada has also been paused, though there is no indication anyone there has been harmed.

Low birth weight contributes to 60% to 80% of neonatal deaths worldwide, according to the World Health Organization. The team did not observe any negative effects of the drug, except for a decrease in the blood flow from placenta to fetus through a shunt between the placenta and fetus called the ductus venosus. Stuff.co.nz reported in March on the results of a study that involved 122 Australian and New Zealand women, half of whom received sildenafil.

But she supports the decision made by Dutch investigators to discontinue to the study.

But it's a tragic example of why even the most promising of treatments needs such extensive experimentation, no matter how much promise they show.

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