The unexpected death of 11 babies in a clinical trial with Viagra in the Netherlands



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They wanted to check if Viagra was good for fetuses with growth problems in the uterus. Unfortunately, they discovered that the effect was totally opposite.

A clinical trial in the Netherlands that gave sildenafil (the generic name of Viagra) to pregnant women had to be stopped after the death of 11 newborns. improve the growth of underdeveloped fetuses.

The pill, which improves blood circulation and dilates blood vessels, may have caused fatal damage to babies' lungs.

Previous trials in the United Kingdom, Australia and Australia. New Zealand found no evidence that the intervention was harmful, but also found no benefit.

At that time, in 2010, the researchers stated that the treatment would only be used in clinical trials

. a full investigation is needed to understand what happened in the Netherlands.

It is not suggested that a crime was committed,

Sick Babies [1] 9659010] Hospitals see hundreds of pregnant women every year whose fetal development is very slow.

We speak of fetuses who, at 22 weeks of gestation, weigh just 300 grams. Their survival expectancy is between 40 and 50%. Under these circumstances, surviving babies have a very low birth weight and, in many cases, their health is delicate.

There is still no medication or therapy for this problem and a treatment that improves weight or prolongs pregnancy. significant for these sick infants

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The drug in which the hopes had been put, sildenafil or Viagra, seems more harmful than advantageous.

Sildenafil Tablets and Placebo Treatment [19659010] The now-suspended Dutch study, which was to continue until 2020, was carried out in 11 hospitals in the Netherlands, including the Medical Center of the Netherlands. University of Amsterdam

In total, 93 women received sildenafil and 90 took a placebo pill.

Of all babies, 20 developed lung problems after birth: three in the placebo group and the rest in the group

11 babies in the sildenafil group died of pulmonary complications [19659002] In the placebo group, there were also fatal results: nine babies died shortly after birth, but it was for another type of complications

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Gynecologist and research director Wessel Ganzevoort was not aware of the bad results until last Thursday when he heard the findings of an independent commission that evaluated the study.

"I was expecting to know that sildenafil worked so well that we would not need the placebo group, but the numbers for all the hospitals in the study were related to completely different story

"Not only was the infant mortality rate for women who consumed Viagra higher, but babies were more likely to get sick. pulmonary. "

Professor Zarcko Alfirevic, of the University of Liverpool, leader of the British side of the research on the effects of sildenafil during pregnancy that we quoted previously, said:" This discovery in the US, " Dutch study is unexpected. 19659002] "A full investigation is necessary because the complications have not been observed in the other similar trials that have been developed in the United Kingdom, Australia and New Zealand," he adds


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