[ad_1]
Following the deaths of 19 babies in the Netherlands, drug trials were stopped with pregnant women who had received Viagra sildenafil. The vasodilator drug was administered at the University Hospital of Amsterdam and in seven other academic medical centers and three other clinics for women whose babies were suffering from severe growth disorders, said the Academic Center of 39; Amsterdam (AMC) in a statement. The study of pregnant women taking sildenafil showed that "adverse effects can occur in babies after birth". Until now, sildenafil has been used primarily as a cure for erectile dysfunction.
"This is not the last thing we want, it's shocking," said Wessel Ganzevoort, senior investigator, to the Dutch Volkskrant newspaper
. Placebo administered
According to the report of the AMC, 19 out of a total of 93 women who had received the active substance died. Eleven of the deceased babies were suffering from lung diseases, especially high blood pressure in the lungs, which can lead to a lack of oxygen. The death of the eight other babies in the Sildanfil group has not been reported. Six newborns in this experimental group had also developed lung problems but survived.
In comparison groups with a total of 90 women whose unborn children also had growth problems, an ineffective placebo was used instead of sildenafil. Out of this group, nine children died, but none of them had lung problems, according to the CMA. Although three babies in this group also had lung diseases, they did not die.
Sildenafil caused no medical harm to mothers
Doctors had promised better blood flow to the placenta through the vasodilator effect of sildenafil, Previous research would have suggested that this could improve the growth of unborn children. However, this has not been confirmed in drug trials in the Netherlands. On the contrary, it has been shown that the use of sildenafil during pregnancy can be dangerous for babies after birth. "The possibility of a blood vessel disease in the lungs seems to be greater, and the possibility of postpartum death seems to be increasing."
All negative consequences occurred after birth; Sildenafil did not cause any medical damage to the mothers. Participating physicians and researchers are aware that the results of drug trials "have a huge impact on women and their environment". All had personal discussions and all the women are "looked after their best" by doctors who participated in the study.
Ineligible funds should not be put on the market
The gynecologist Wessel Ganzevoort, the Amsterdam newspaper "Volkskrant" said: "The Dutch doctors are cautious and we want to rigorously investigate whether a cure is effective and safe. Studies such as the one we have just adopted are also aimed at preventing the placing on the market of unreliable funds. According to the newspaper, he arrives in the Netherlands several times a year that drug trials are stopped for security reasons.
The AMC had informed of the immediate end of the study on Monday. The responsible health authorities were involved. The study began in 2015. Originally, it is expected to last until 2020, with a total of about 350 patients participating.
In video: Caesarean section: doctor warns of dangerous "badl seeding"
Source link
