Dutch halt Viagra in pregnancy trial after 11 babies die

11 babies die in drug trial after their mothers were given prenatal Viagra

10 to 15 other patients are waiting to see if their children have been affected, The Guardian reports.

The study started in 2015 and involved 11 hospitals.

Now that it's no longer under patent, the drug is being explored by research companies as a wonder drug for a range of other conditions.

"All participants were approached personally and nearly everyone was informed and knows by now whether they have taken the drug or the placebo".

Among the roughly equal control group, just three babies had lung problems and none died.

'All adverse effects occurred after birth. British researchers who were part of the same global collaboration as the Dutch and Canadians reported that sildenafil "did not prolong pregnancy, improve survival, or reduce short-term neonatal morbidity".

As for what went wrong, the theory is that the drug may have elevated blood pressure in the lungs, reducing the amount of oxygen the growing babies received.

Of the 93 women who took sildenafil in the trail, 19 babies died - including 11 due to a possible lung disease thought to cause a form of high blood pressure in the lungs.

It appears the sildenafil used in the trial, which promotes blood flow, may have caused lethal damage to the babies' lungs. At the time they were treated, the mothers did not know which treatment they were receiving, which is standard in clinical trials. It can lead to stillbirth or neonatal death, and babies that survive are still at higher risk for infections and often suffer from long-term problems such as obesity and cardiovascular disease.

Research lead and gynaecologist Wessel Ganzevoort is reportedly "shocked" by the results.

In total, 93 women were given sildenafil while the remaining 90 were given a dummy drug or placebo.

The trial has now been cancelled and an investigation is ongoing.

"The Principle Investigators at the Amsterdam University Medical Centre have confirmed a non-Pfizer manufactured generic version of sildenafil was used but that no clinical trial participants were administered Viagra, Pfizer sildenafil or any other Pfizer medicine", the statement said.

"It needs a thorough investigation because the complications were not seen in the two other, similar trials that have already been done in the United Kingdom and Australia and New Zealand". It was sildenafil, the active ingredient in many erectile dysfunction drugs.

Prior to the experiments, the growth of each of the unborn babies was found to be limited and the prognosis viewed as poor.

A similar trial conducted in Canada has been paused following the outcome of the Amsterdam trial. We contacted the one Canadian woman who was now in the trial, directing her to stop taking the drug or placebo.

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