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In the Netherlands, medical trials were stopped last week after 11 newborns died of lung problems. The experiment in which the mothers of the children had participated during the pregnancy provided for the intake of sildenafil citrate, known under the trade name of "Viagra". The purpose of the research was to determine if this drug, marketed as a cure for male impotence, could prevent premature births in pregnant women with placental osteo-development, that is, to say with an underdeveloped placenta. Children born prematurely because of this condition are unlikely to survive because they are born with low weight.
Sildenafil is a vasodilator, so the authors of the experiment hoped that this would make more unaffected placental women. blood and nutrients would reach the fetuses, making them grow older. The study, which began in 2015 and was to last until 2020, was based on previous experiments on rats and was not the first experiment of this type performed on pregnant women. Indeed, studies have already been conducted on the effects of sildenafil on pregnant women in the UK and Australia and New Zealand in 2010: no harmful side effects were detected in these trials, but none benefit has been badociated with the use of sildenafil. The results of these studies were published after the start of the experimentation in the Netherlands.
The Dutch study involved 11 different hospitals, including that of the University of Amsterdam that ran the trial. Sildenafil was prescribed to 93 women, while another 90 received placebo. Of the children born to these women, twenty developed lung problems. Of these, three were in the placebo group, while the eleven who died were children of women who received sildenafil. Seventeen more children died of different problems, not related to sildenafil: eight of those who gave birth to the women who took the drug, nine of those who took the placebo.
One thing that needs to be taken into account is that this experiment is like those that are made by pharmaceutical companies to check the effectiveness of a new drug and then make it approved for use. # 39; use. It was conducted in academia and informed participants about the risks that a pregnancy with an underdeveloped placenta has on fetal health. Viagra and its generic version have been around the world for over twenty years and have no major side effects.
It is not clear why the eleven newborns died, but it is thought that sildenafil caused high blood pressure in the lungs, causing little oxygen to reach the children. For the moment, nothing indicates errors on the part of the medical staff. Between 10 and 15 women are waiting to find out if their children have been harmed by sildenafil
In Canada, a similar trial was underway in the Netherlands: it was suspended as a precautionary measure. In an interview with the Dutch newspaper De Volkskrant the gynecologist Wessel Ganzevoort, head of the study on Sildenafil, said: "We wanted to show that there is an effective way to raise children. But the opposite has happened. I'm shocked. The last thing we wanted was to hurt the patients. "
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