Babies die after mums given sildenafil in Dutch trial

Babies die after mums given sildenafil in Dutch trial

Babies die after mums given sildenafil in Dutch trial

The parents of around a dozen -babies in the trial - who are as yet unborn or in intensive care - now face a nervous wait.

In 2015, hospitals in the Netherlands recruited 183 women whose pregnancies were likely to be adversely affected by placental development.

Viagra was originally developed by Pfizer but is now off patent and available as a generic. Ninety-three women were treated with the drug, and 90 were treated with the placebo, or dummy pill.

Recent randomised clinical trials comparing the drug with a placebo had detected no adverse effects on healthy mothers or infants, giving the all clear for others to conduct further testing. But the drug may have resulted in lethal damage to the babies' lungs.

But 17 children developed high blood pressure in the lungs meaning they did not get enough oxygen, and 11 subsequently died. Ganzevoort, who's at the Amsterdam University Medical Center (AUMC), knew that probably meant one of two things: Either the drug worked so well that continuing to give a placebo to half of the mothers in the trial would be unethical, or the study had to be stopped because sildenafil was causing serious complications. At the time they were treated, the mothers did not know which treatment they were receiving, which is standard in clinical trials.

She noted that the drug is used to treat pulmonary hypertension, defined by the American Heart Association as high blood pressure in the heart to lung system, so "at first review it may seem unlikely that sildenafil has caused this problem. They temporarily stopped", - said the leader of the study, gynecologist Wessel Ganzevoort.

The pregnant women who had agreed to take part in the trial all had unborn babies whose growth had been severely limited in the womb.

The research had been borne out in rats, and so the next step was humans: Some 93 pregnant Dutch women whose placentas weren't operating optimally were given sildenafil, the drug better known as Viagra.

But she supports the decision made by Dutch investigators to discontinue to the study.

Health Canada said in an emailed statement that it has contacted the University of British Columbia concerning the Canadian trial. That poses a hard dilemma for doctors: Inducing birth too early increases the risk of complications, but waiting too long could lead to developmental anomalies or stillbirth.

Trials in the UK, Australia and New Zealand in 2012 had found no benefit from the drug, but also no side effects.

It can mean babies are born prematurely, with a very low birth weight and poor chances of survival. The 93 women who were selected for the study had compromised placenta, which were underperforming.

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