Eleven babies have died after their mothers were given Viagra during their pregnancies as part of a drug trial in the Netherlands. The purpose of the trial led by Amsterdam University Medical Centre (UMC) was to ascertain whether sildenafil, the drug sold under the brand name Viagra, can help boost the growth of infants in the womb. The 93 women who were selected for the study had compromised placenta, which were underperforming.

Viagra is a drug that is used for erectile dysfunction in men, since it dilates the blood vessels and improves blood circulation in the penis. It is often prescribed to people with high blood pressure. The research, which was earlier conducted on rats, gave the impression that the drug would improve blood flow in the placenta on these women whose organs were underperforming.

In these women, the compromised placenta was affecting the growth of the foetuses in the womb. Since at present, there is no treatment to correct the problem, the women were selected for the drug trial, which showed favourable results in animal studies.

The independent committee, which was overseeing the trial, noticed that many babies born to these women had lung problems. So they decided to terminate the trial last week. Apart from the 11 babies who died, 17 of them developed the lung problems and eight died of unrelated conditions. But three of the women among the 90 in the control group who took placebo had children who developed the same lung issues. But none of the deaths could be linked to Viagra and nine babies had died of an unrelated cause.

Although there is nothing to suggest the link between the trial and the deaths, the speculation is that the children died since Viagra caused high blood pressure in the lungs. This could have led to the babies receiving less oxygen. Around 10-15 women from the trial are now waiting to find out whether the drug had anything to do with their babies’ deaths.

A spokesperson from the UMC told the media that the trial is believed to have followed the correct protocol, but they expect an external investigation to be launched into the matter. The hospital said that sildenafil may have been harmful to babies after birth.

The led researcher of the study, Gynaecologist Dr Wessel Ganzvoort expressed his regret to the Dutch newspaper De Volkskrant: “We wanted to show that this is an effective way to promote the growth of the baby. But the opposite happened. I am shocked. The last thing you want is to harm patients.” He added that the team has notified Canadian researchers who were also conducting a similar research.

The research had begun in 2015 and was expected to go on till 2020, until the tragedy forced its termination. A total of 350 patients would have participated. A 2015 trial in UK showed that there was nothing to suggest the drug’s efficacy or its risks to patients. Dr Ganzvoort said that in Netherlands, the doctors are quite cautious and the safety and effectiveness of the drug must be demonstrated through placebo-controlled studies.

(The above story first appeared on LatestLY on Jul 25, 2018 03:50 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).