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The Dutch doctors were trying to answer to a simple question about a drug: Could the active ingredient of Viagra be used to help a particular group of babies at risk often born tiny and premature with low chances of survival?
The study had already been conducted in New Zealand and Australia, according to Amsterdam Universitair Medische Centra (University Medical Center), which ran the latest trial. The Dutch component involved 183 pregnant women who were suffering from a fetal growth restriction, where an underdeveloped placenta can not provide enough oxygen or nutrients to a pregnant baby.
Sildenafil, a generic version of the erectile dysfunction drug Viagra, was administered to 93 pregnant women; Another 90 received inert placebo. Doctors from 11 hospitals planned to study mothers and their children until 2020.
Then babies began to die.
After their birth, 11 babies whose mothers had received sildenafil developed a form of high blood pressure. the lungs, which killed them, according to the researchers. Six babies in this group also suffered from the complication but survived.
In the placebo group, three developed the disorder, but all survived.
"The possibility of a disease of the blood vessels of the lungs seems to be" Amsterdam UMC said in a statement
and there was "no positive effect for children on d?" other results, "the researchers concluded. "All side effects occurred after birth … Based on these findings, the study stopped immediately."
Doctors admitted that they had more than Questions What Answers: What about the drug that caused the babies' deaths? Why were there no similar problems for babies in previous studies?
In a statement, Pfizer, the manufacturer of Viagra, expressed "sympathy for the trial participants and their families" but said that.
[Watch the moment drivers stopped to rescue an infant abandoned on a freezing street]
"Pfizer did not participate in any aspect of this trial and neither financed nor provided proceeds for the trial," the statement said. "In addition, senior researchers at the Medical Center of Amsterdam University confirmed that a generic version of sildenafil not manufactured by Pfizer was being used, but that no participant in clinical trials Received from Viagra, Pfizer sildenafil or any other Pfizer medication. "
claimed that "the safety and effectiveness of Viagra has been well documented in clinical studies."
The researchers said that their main goal now is to know what happened.
Doctors intend to "extensively" badyze all the data that they have. "This discovery in the Dutch study is unexpected," Zarko Alfirevic, professor at the University of Liverpool and one of the authors cited. in a similar study in the UK, told the BBC. "We need to be cautious at this point to find out more.It needs a thorough investigation because the other two similar tests have already been done in the UK, Australia and New Zealand."
Growth restriction Intrauterine infection occurs when a problem or abnormality prevents the fetal cells of According to Stanford Children's Health, more than a dozen factors can cause a restriction of intrauterine growth, including included maternal diseases such as diabetes or high blood pressure, chromosomal abnormalities in the baby or several types of infections. 19659023] Infected babies can be stillborn or have long-term growth problems that last until childhood
There is no known cure.
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