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A Canadian clinical trial using sildenafil, sold under the brand name Viagra, was put on hold following the death of 11 babies of mothers who were taking the drug at a similar trial in the Netherlands.
Participating hospitals said Tuesday. A spokesperson for Health Canada says the government is working with the University of British Columbia, which sponsors the Canadian equivalent, to find out what to do next, including a stay of the trial, if necessary.
The lawsuit was stopped on Monday, about half of the 183 pregnant women taking part in taking sildenafil, said the University Medical Center (AMC) of the University of Amsterdam.
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The study began in 2015 and involved 11 hospitals. It was designed to investigate the possible benefits of increased blood flow to the placenta in mothers whose unborn babies were severely underdeveloped.
Fifteen women who took the drug have not yet given birth
Sildenafil would have a positive effect on the growth of babies, "said the AMC." The first results of the present study showed that there could be adverse effects for the baby after birth. "
Still, the results showed that 17 babies were born with lung conditions and 11 died. about equal, only three babies had lung problems and none died.
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Of the women taking sildenafil, 11 babies died because of a "possibly related lung disease" that caused high blood pressure in the lungs and may be due to a reduction in levels d & # 39; oxygen.
that the risk of sickness of the blood vessels in the lungs "seems to be greater and the risk of death after birth seems to have increased.The researchers found no positive effect for the children on other results", said the AMC.
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said that the small number of trials with pregnant women "There have been d & # 39; other studies in this area, involving preliminary work using animals and using pregnant women, and there was no indication that the treatment was dangerous based on previous research, "he said.
The drug was originally developed by Pfizer, but is now off patent and available as a generic. Pfizer has no immediate comment
– with a Global News file
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