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Following the deaths of 19 babies in the Netherlands, drug trials were stopped with pregnant women who received active Viagra sildenafil . The vasodilator substance was administered at the University Hospital of Amsterdam and at seven other academic medical centers and three clinics to women whose babies had severe growth disorders.
This was stated in a statement from the Academic Center of Amsterdam (AMC). The study in pregnant women taking sildenafil showed that "there can be adverse effects on babies after birth". Until now, Sildenafil has been used primarily as a remedy for erectile dysfunction.
19 babies died
According to the AMC report, 19 babies out of a total of 93 women who had received the drug 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. No information was provided on the cause of death of the eight other babies in the Sildenafil group . Six newborns from 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, instead of sildenafil an ineffective placebo was administered. Out of this group, nine children died, but none of them had lung problems, according to the CMA. Although three babies in this group had also had lung diseases, but had not died.
Doctors had promised better blood flow to the placenta from the proven vasodilator effect of sildenafil, it was said. Previous research has suggested that this could improve the growth of unborn children. However, this has not been confirmed in drug trials in the Netherlands. It has instead been shown that ingestion of sildenafil during pregnancy may be dangerous for babies after birth. "The possibility of blood vessel disease in the lungs appears to be greater and the possibility of postpartum death appears to be increasing."
No harm to mothers' health
All negative consequences occurred after birth; in the case of mothers, sildenafil caused no medical harm. 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 women are treated "as well as possible" by physicians who participated in the study.
The head of the study, the gynecologist Wessel Ganzevoort, told the Amsterdam newspaper "Volkskrant": The Dutch doctors are cautious, we want to thoroughly examine whether a cure is effective and safe. " Studies such as the one we have just adopted are also aimed at preventing unreliable funds from being put on the market.The newspaper reports that there are several times a year in the Netherlands that drug attempts are stopped for
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
(APA / dpa)
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