Dutch trial with Viagra
halted after 11 babies die
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[July 25, 2018]
AMSTERDAM (Reuters) - A Dutch trial with
sildenafil, sold under the brand name Viagra, has been immediately
halted after 11 babies of mothers using the medication died, one of the
participating hospitals said on Tuesday.
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When the trial was stopped on Monday, roughly half of 183 pregnant
women participating were taking sildenafil, the Amsterdam
University's Academic Medical Center (AMC) said.
The study started in 2015 and involved 11 hospitals. It was designed
to look at possible beneficial effects of increased blood flow to
the placenta in mothers whose unborn babies were severely
underdeveloped.
Around 15 women who took the medication have not yet given birth.
"Previous studies have shown that sildenafil would have a positive
effect on the growth of babies. The first results of the current
study showed that there may be adverse effects for the baby after
birth," the AMC said.
Yet the results showed that 17 babies were born with lung conditions
and 11 died. Among the roughly equal control group, just three
babies had lung problems and none died.
Among the women taking sildenafil, 11 of the babies died due to "a
possibly related lung condition" that caused high blood pressure in
the lungs and may have resulted from reduced oxygen levels.
An interim analysis found that 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 researchers found no positive effect
for the children on other outcomes," the AMC said.
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Stephen Evans, a professor of pharmacoepidemiology at the London
School of Hygiene & Tropical Medicine, said the small number of
trials with pregnant women has limited our knowledge of medicines in
pregnant women.
"There have been other studies in this area, both involving
preliminary work using animals and using pregnant women, and there
was no indication that the treatment was dangerous based on previous
research," he said.
The drug was originally developed by Pfizer but is now off patent
and available as a generic. Pfizer had no immediate comment.
(Reporting by Anthony Deutsch; Additional reporting by Kate Kelland
and Ben Hirschler; Editing by Adrian Croft)
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