Queensland Viagra trial for mothers stopped after babies’ deaths in Dutch study

By @chelean on
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Newly born babies rest inside a ward at a hospital on the occasion of "World Population Day" in the northern Indian city Lucknow in this file picture taken July 11, 2009. Reuters/Pawan Kumar/Files

A Queensland study using Viagra on pregnant women has been temporarily halted after 11 babies died in a different study in the Netherlands. The mothers in the Dutch experiment were also taking Sildenafil, a drug sold as Viagra.

Started in 2015, the Dutch study involved 183 pregnant women. Half of them were taking Sildenafil. The aim was to look at possible beneficial effects of increased blood flow to the placenta in mothers whose unborn babies were severely underdeveloped. The clinical trial was stopped on Monday when 11 babies of those mothers taking Sildenafil died, the Amsterdam University’s Academic Medical Centre said.

The Queensland trial also used Sildenafil but with a different aim. Mater Research Institute professor Sailesh Kumar, who specialises in maternal foetal medicine, said they used a much lower dosage of the drug. Their study was also over a significantly shorter time frame.

“Our study is in a very completely different context,” he told AAP. “We are using Sildenafil in women with full-term pregnancies who are appropriately grown. These babies are at 37 and beyond weeks. Our primary aim is to see if it reduces the risk of a baby becoming distressed in labour.”

The professor said that the Dutch study — which is part of a broader research conducted in Australia, New Zealand and the UK — was the first one to come up with any negative effects. On whether the Queensland study would be continued is still unclear. Kumar said a decision on the matter would be decided over the next one or two weeks. They have stopped recruiting mothers for the study in the meantime.

“It is a temporary pause and no decision has been made either way,” he said, adding that their study had so far included about 200 women. Their plan was to recruit another 200 women over the next year. “We have not seen any complications but nevertheless are very cautious and will review all the data again.”