Published: Sat, July 28, 2018
Medicine | By Brett Sutton

Viagra trial on pregnant women stopped after 11 babies die

Viagra trial on pregnant women stopped after 11 babies die

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

The AMC said in a statement that the likelihood of lung blood vessel damage "appears to be greater and the chance of death after birth seems to have increased", reports SBS.

The research, conducted in 10 hospitals throughout the Netherlands, involved 183 pregnant women whose babies had a severe growth limitation early in pregnancy.

Now that it's no longer under patent, the drug is being explored by research companies as a wonder drug for a range of other conditions. In the trial, 93 moms were treated with sildenafil, while 90 others received a placebo. "17 children have developed lung problems, and 11 died", - stated in the message.

In the placebo group nine babies died, none from the lung disease.

The Queensland trial has had no adverse effects so far.

Researchers conducting a similar trial in Canada have been notified and have suspended their research.


But the study was halted last week after an independent monitoring panel learned that a higher-than-expected number of babies were being born with lung problems.

After they were born, 11 of the babies whose mothers had been given sildenafil developed a form of high blood pressure in the lungs, which killed them, the researchers said.

In total, 93 Dutch women were given sildenafil - better known by its brand name Viagra - as part of the trial. Six other babies also had the same lung condition but survived. The drug dilates the blood vessels.

In the Queensland study, the drug was used over a significantly shorter time frame and for different reasons. This is in line with the conclusion by the authors of the United Kingdom study, which recommended that "clinicians worldwide should stop prescribing sildenafil for this indication outside of research studies with explicit participants' consent".

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. 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.

"Pfizer was not involved in any aspect of this trial, and neither funded nor provided product for the trial", 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.

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.

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