Eleven Infant Deaths Halt Trial of Sildenafil in Pregnant Women

28 July, 2018, 08:10 | Author: Denise Dawson
  • The Queensland study was looking into whether sildenafil reduced the risk of foetal distress in labour among women with full-term pregnancies and normally grown babies

Some of the drug probably reached the fetus before birth, where it may have put dilating forces on the lung vessels, she says; that might have led to an increase of constricting signals from the fetus itself to prevent them from opening prematurely.

The research was being carried out at 10 hospital sites in the Netherlands, with the aim of discovering whether sildenafil could improve blood flow through underperforming placentas.

In the Dutch study, 93 women had been given sildenafil and 90 got a placebo drug. Of those who took Viagra, 17 babies exhibited the lung problems, 11 of which passed away.

In the roughly equal control group, just three babies had lung problems and none died. Among the 20 other Canadians who have already participated in the trial, researchers are not aware of any adverse outcomes.

Professor Zarko Alfirevic from the University of Liverpool, who led part of the United Kingdom research into sildenafil in pregnancy, said that the findings in the Dutch study were "unexpected".

But an independent committee which was supervising the research realised that more of the babies than expected had been born with issues with their lungs.

Among the women taking Sildenafil, 11 of the babies died due to "a possibly related lung condition" that caused high blood pressure in the lungs and may have resulted from reduced oxygen levels. The trial was testing the use of the pharmaceutical sildenafil in assisting placenta growth.

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183 women whose pregnancies were deemed likely to be affected by slow placental development were recruited for the trial from all across the Netherlands. Six babies were born with the lung disorder and survived.

Senior researcher Wessel Ganzevoort, who is based at the AMC teaching hospital in Amsterdam, told Hart van Nederland it was focusing on supporting the parents.

The trial in Amsterdam was focussed around using increased blood flow to assist slow growing placentas. A trial in Ireland has yet to start enrollment; researchers in that study did not respond to emails today, but Mol expects it will be canceled.

Sildenfail is an erectile dysfunction medicine commonly sold under the brand name Viagra.

"The Principle Investigators at the Amsterdam University Medical Centre have confirmed a non-Pfizer manufactured generic version of sildenafil was used but that no clinical trial participants were administered Viagra, Pfizer sildenafil or any other Pfizer medicine", the statement said. Its worldwide prevalence is 15.5%, comprising about 20 million children born each year, but the vast majority of low-birth-weight cases - 96.5% - are in developing countries.

The study is part of broader research in Australia, New Zealand and the UK.

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