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Erectile Dysfunction Drug Trial Involving Pregnant Women Stopped After 11 Newborns Die

26 July 2018

Professor Zarcko Alfirevic, from the University of Liverpool, who led part of the United Kingdom research into sildenafil in pregnancy that found no benefit in terms of improving baby growth, said: "This finding in the Dutch study is unexpected".

The drug is known more commonly by the name Viagra and more often associated with assisting with erectile dysfunction by improving blood flow.

Viagra increases blood flow, and previous studies had showed the drug to improve the functioning of the placenta, the AMC said in a statement. 17 of their children were born with a lung condition, .

The spokesman said: 'The Amsterdam UMC has concluded studying the effects of the medication sildenafil, also known as Viagra, which was given to pregnant women whose foetuses showed severe growth defects'. It's feared that the drug caused blood pressure to build up in the lungs, meaning the babies received a diminishing amount of oxygen. There is nothing to suggest the trial was mishandled.

"We wanted to show that this is an effective way to promote the growth of the baby", head researcher Wessel Ganzevoort told the Dutch newspaper De Volkstrant. But the opposite happened.

"The last thing you want to do is harm patients".

"We have already notified Canadian researchers who are conducting a similar study".

"We are always very cautious so there will be a temporary stop to the recruitment in Queensland until we get further information", he said.

The research began in 2015 and was due to run until 2020, involving 350 patients.

An interim analysis found the chance of blood vessel disease in the lungs "appears to be greater and the chance of death after birth seems to have increased". The Guardian reports some in the test group have anxious days ahead: As many as 15 women have yet to know what their child's outcome will be.

'All adverse effects occurred after birth.

The researchers found no positive effect of the drug, the Amsterdam University's Academic Medical Center (AMC) said.

'All participants were approached personally and nearly everyone was informed and know by now whether they have taken the drug or the placebo'. But the drug may have resulted in lethal damage to the babies' lungs. "Foreign colleagues let slip that they sometimes prescribed it, with good results", she said.

"I have experienced in my own consulting room that pregnant women asked for it". Whether they have ordered it via the internet? "We did state that sildenafil normally is not prescribed during pregnancy, and that no unusual things had been observed in this indication, which is a fact", Ganzevoort says, "but we could have stated more specifically that we don't know what we don't know, as I did during all the counseling I did myself".

"In the Netherlands, doctors are reasonably cautious". Spokeswoman Dervila Keane wrote in an email Tuesday that the research is "an investigator initiated study and Pfizer have no involvement in the trial".

Erectile Dysfunction Drug Trial Involving Pregnant Women Stopped After 11 Newborns Die