The death of 11 babies through 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,

Infants sick [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 very sick babies.

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

Sildenafil pills and placebo treatment

The now-suspended Dutch study, which had to continue until 2020, was developed in 11 hospitals in the Netherlands, including the Medical Center from the University of Amsterdam

A total of 93 women received sildenafil and 90 took a placebo pill

20 developed pulmonary problems after birth: three in the group placebo and the rest in the treatment group with Viagra.

11 babies in the group of pulmonary deaths .

In the placebo group, there were also fatal results: nine babies died soon after birth, but this was due to other complications

The gynecologist and research leader Wessel Ganzevoort did not have a baby. was unaware 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 patients. But the numbers for all the hospitals participating in the study told a story completely different.

"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] "Comprehensive research is needed because complications have not been observed in other similar trials that have been developed in the United Kingdom, Australia and New Zealand"




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