The Dutch experiment has led to the death of 11 infants

Between 10 and 15 more women now face an anxious wait to see if their unborn children will be affected.

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

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.

Pfizer held the drug's patent until December.

During the study, another 90 women took a placebo pill with no active ingredients. Among a control group of roughly an equal size, there were only three babies with lung issues and no deaths.

A similar United Kingdom trial, the results of which were published in December, found no difference in neonatal deaths, and no adverse affects were linked to the drug.

Researchers conducting a similar trial in Canada have been notified and have suspended their research. It was aimed at increasing the blood flow to the placenta in cases where unborn babies were critically undeveloped.

But out of the 93 women using the drug, 19 babies died, 11 of them possibly due to a form of high blood pressure in the lungs which may be linked to the drug. Growth restriction is diagnosed using ultrasound, but now the only medical treatment is closely monitoring the pregnancy and inducing birth when the risk of stillbirth is deemed high. Outside of research studies with explicit participants' consent, they said physicians should stop prescribing sildenafil for fetal growth restriction.

"We are using Sildenafil in women with full-term pregnancies who are appropriately grown".

Lead investigator Wessel Ganzevoort could not tell Nieuwsuur exactly how many now still pregnant women were prescribed the drug. Spokeswoman Dervila Keane wrote in an email Tuesday that the research is "an investigator initiated study and Pfizer have no involvement in the trial".

SIL, aka Viagra, is a drug approved by the Federal Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of erectile dysfunction and pulmonary hypertension in adults. 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.

Low birth weight contributes to 60% to 80% of neonatal deaths worldwide, according to the World Health Organization. Stuff.co.nz reported in March on the results of a study that involved 122 Australian and New Zealand women, half of whom received sildenafil.

Huf-Germain said she did not recall being told of any risks to her child at the start of the trial, but such was the desperation of the women involved that few would have comprehended the possible consequences.

(Copyright © 2015. All Rights Reserved.)
 
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