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Dutch doctors were trying to answer a simple question about a popular drug: Could the active ingredient in Viagra be used to help a particular group of at-risk babies often born tiny and premature with slim chances of survival?

The study had already been conducted in New Zealand and Australia, according to Amsterdam Universitair Medische Centra (University Medical Center), which headed the latest trial. The Dutch component involved some 183 pregnant women who suffered from fetal growth restriction, where an underdeveloped placenta can’t get enough oxygen or nutrients to a gestating baby.

Sildenafil, a generic version of the erectile dysfunction drug Viagra, was given to 93 pregnant women; another 90 were given an inert placebo. Doctors across 11 hospitals planned to study the mothers and their children through 2020.

Then the babies started dying.

After they were born, 11 of the babies whose mothers had been given sildenafil developed a form of high blood pressure in the lungs, which killed them, the researchers said. Six babies in that group also suffered the complication but survived.

In the placebo group, three developed the disorder, but all of them survived.

“The chance of a disease of the blood vessels of the lungs appears to be greater and the chance of death after birth seems to have increased,” Amsterdam UMC said in a release.

And there were “no positive effects for the children on other outcomes,” the researchers concluded. “All adverse effects occurred after birth. . . . Based on these findings, the study stopped immediately.”

Doctors conceded they had more questions than answers: What about the drug had caused the babies to die? Why were there no similar problems for babies in the previous studies?

In a statement, Pfizer, the maker of Viagra, expressed its “sympathy for the trial participants and their families” but said the company had nothing to do with the trial.

“Pfizer was not involved in any aspect of this trial, and neither funded nor provided product for the trial,” the statement said. “In addition, the Principle Investigators at the Amsterdam University Medical Centre have confirmed a non-Pfizer manufactured generic version of sildenafil was used but that no clinical trial participants were administered Viagra, Pfizer sildenafil or any other Pfizer medicine.”


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The company asserted that “the safety and efficacy of Viagra has been well documented in clinical studies.”

Researchers said their principle goal now is to find out what happened.

Doctors intend to “extensively” analyze all the data they’ve been able to collect so far, and “the development of the children will be closely monitored.”

“This finding in the Dutch study is unexpected,” Zarko Alfirevic, a professor at the University of Liverpool and one of the authors cited in a similar United Kingdom study, told the BBC. “We need to be careful at this point to find out more. It needs a thorough investigation because the complications were not seen in the two other, similar trials that have already been done in the U.K. and Australia and New Zealand.”

Intrauterine growth restriction occurs when some problem or abnormality prevents a fetus’s cells from growing or makes cells decrease in size, according to Stanford Children’s Health.

More than a dozen things can cause intrauterine growth restriction, including maternal diseases like diabetes or high blood pressure, chromosomal abnormalities in the baby or several types of infection.

Affected babies can be stillborn or have long-term growth problems that last well into childhood.

There is no known cure.

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