Article image Dutch halt Viagra in pregnancy trial after 11 babies die

Jul 28, 2018, 08:12
Article image Dutch halt Viagra in pregnancy trial after 11 babies die

Between 10 and 15 women were still taking part up in the trial until last Thursday and now face a terrifying wait to learn whether their unborn children have been affected.

He said: "The likelihood of developing a lung condition was much higher (among Viagra takers), as was the chances of death shortly after birth".

The drug was originally developed by Pfizer but is now off patent and available as a generic.

In fact, the buzz on its potential has been building over the years, with rumours that doctors have already been suggesting pregnant women take the drug.

In comparison, nine babies born to women treated with the placebo died, but none of them had the lung disorder.

The Queensland trial has had no adverse effects so far.

Researchers at the University of British Columbia in Vancouver, Canada, have stopped a similar study, pending an in-depth investigation of what happened in the Netherlands.

It is feared the Viagra the mothers had taken caused high blood pressure in the babies lungs, leading to the babies receiving too little oxygen.

The trial had seen 93 women given sildenafil, and of their babies, 17 developed lung problems and 11 have died.

Earlier this week, Amsterdam University Medical Centre (UMC) announced an early end to a clinical trial testing a new use for the pharmaceutical sildenafil in the wake of newborn deaths.

According to the statement from Amsterdam University Medical Center, 183 women had participated in the clinical trial at 11 locations in the Netherlands since it began in 2015.

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.

The Dutch trial was created to investigate whether Viagra was useful in promoting the growth of severely underdeveloped babies in the womb. Spokeswoman Dervila Keane wrote in an email Tuesday that the research is "an investigator initiated study and Pfizer have no involvement in the trial".

It can mean babies are born prematurely, with a very low birth weight and poor chances of survival.

"We are not aware of an increase in adverse outcomes among the 21 Canadian trial participants. 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".

Viagra is typically prescribed to men with erectile dysfunction, and experts hypothesized that the drug's ability to dilate blood vessels would improve the performance of the placentas in pregnant women. "Combining our results with those of the other trials and zooming in on subgroups might give more clarity", he says.

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