Published: Sat, July 28, 2018
Medicine | By Daryl Nelson

Infant Deaths Halt Trial of Sildenafil in Pregnant Women

Infant Deaths Halt Trial of Sildenafil in Pregnant Women

The Dutch trial was stopped last week after a review committee found that 17 babies born to women taking part developed lung problems, and 11 of the children died.

An interim analysis found that the chance of blood vessel disease in the lungs "appears to be greater and the chance of death after birth seems to have increased".

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

'All participants were approached personally and nearly everyone was informed and know by now whether they have taken the drug or the placebo'. It said researchers expected all such usage of the drug to be stopped and that further research should examine the effects and safety of the substance when used in pregnancy. And babies born too small can experience a host of problems, including smaller head sizes, lack of blood flow to the intestines and death. Out of 93 babies born in the trial, 19 died, including 11 possibly from a lung condition linked to the medicine that resulted in reduced oxygen levels.

"Within the NZAus trial only two cases of pulmonary hypertension were reported, in one case the mother had received sildenafil and the other placebo therapy", said chief investigator of the AusNZ study Dr Katie Groom.

More than a dozen things can cause intrauterine growth restriction, including maternal diseases like diabetes or high blood pressure, chromosomal abnormalities in the baby or several types of infection.

About 15 women who took the medication have not yet given birth.

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In total 93 women were prescribed the drug at 10 hospitals across the country in an attempt to fix growth defects in their unborn children, the Daily Mail reports. 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. The doctors decided that the child would be better to stay and develop inside the mother.

Blood vessel dilator sildenafil is the active ingredient in Pfizer's off-patent erectile dysfunction drug, Viagra.

Low birth weight contributes to 60% to 80% of neonatal deaths worldwide, according to the World Health Organization.

A second trial with the same drug in Canada has also been paused, though there is no indication anyone there has been harmed.

A joint Australian-New Zealand team whose results from a similar trial were presented at a recent meeting didn't find any benefits either, but also didn't see complications, says study leader Katie Groom of the University of Auckland in New Zealand.

"The women in our trial used up to three tablets - but generally only one tablet during labour", Professor Kumar said.

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