Eleven babies die as pregnant women are given Viagra during drug trial

At least eleven babies die after their mothers took Viagra while pregnant

At least eleven babies die after their mothers took Viagra while pregnant

A Queensland study on reducing foetal distress during childbirth through the use of Viagra has been paused after the use of the same drug resulted in the death of 11 babies in The Netherlands.

Almost a dozen babies died during a trial where their mothers were given Viagra during their pregnancy.

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.

But doctors believed that its properties in dilating blood vessels could help promote a better flow of blood into the placenta and "stimulate the growth of the unborn child" whose development had been retarded in the mother's womb, the hospital said in a statement.

The parents of around a dozen babies in the trial - who are unborn or in intensive care - now face a nervous wait.

"The researchers found no positive effect for the children on other outcomes", the AMC said. There is nothing to suggest the trial was mishandled.

There is always a risk in clinical trials, however, says Indira van der Zande, who recently finished her Ph.D. thesis on pregnant women in clinical research at the University Medical Center Utrecht in the Netherlands.

Twenty babies developed lung problems after birth - three in the placebo group and the rest in the treatment group.

In total, 93 women were given sildenafil and 90 were given a dummy drug or placebo.

Between 10 and 15 women are waiting to find out if their child has been hurt in the trial. The study was started in 2015 and was due to run until 2020, with 350 patients participating.

In an interview with the Dutch daily newspaper De Volkskrant, the leader of the research, the gynaecologist Wessel Ganzevoort, said: "We wanted to show that this is an effective way to promote the growth of the baby". But the opposite happened. I am shocked. The last thing you want is to harm patients. "We will contact the 20 other Canadian women who have already participated in the trial", Lim wrote in an email. That research has now been temporarily stopped, she said.

Amsterdam University Medical Centre (UMC) has announced the premature end to a clinical trial after a high number of newborn baby deaths.

According to doctors, a provisional analysis showed that Viagra "might be detrimental for babies after birth". The informed consent form they were asked to sign does not mention any potential negative effects for the child. "However, it is biologically plausible that withdrawal from the drug at birth has led to a rebound effect on the pulmonary vasculature", meaning the discontinuation of the drug at birth may have led to the complication.

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".

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