Canada halts drug trial after Dutch baby deaths
Women given Viagra in study on fetus growth
Canadian researchers have halted a clinical trial studying whether Viagra can help pregnant women with a condition that stunts fetus growth after similar research in the Netherlands led to an increase in baby deaths.
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.
“We wanted to show that this is an effective way to promote the growth of the baby. But the opposite happened,” lead researcher Wessel Ganzevoort told the Dutch newspaper De Volkskrant this week. “I am shocked. The last thing you want is to harm patients.”
Ganzevoort, a gynecologist at the Amsterdam University Medical Centre, said he has notified Canadian researchers conducting a similar study, and they have temporarily stopped their research.
A team led by Kenneth Lim at the University of British Columbia is part of an international research effort looking at the effectiveness of sildenafil, the generic name of Viagra, in treating women with a condition called early-onset intrauterine growth restriction.
Lim called the news out of the Netherlands deeply concerning.
“The loss of a child under any circumstance is a tragedy for the parents and their loved ones, and we were very saddened and concerned upon learning of this news late last week,” he said in a statement. He said the one woman currently receiving sildenafil has been told to stop. Among the 20 other Canadians who have already participated in the trial, researchers are not aware of any adverse outcomes.
“But we cannot take any chances with the health of mothers and their infants, so we moved quickly to suspend any further activity until we, our research colleagues around the world, and our respective monitoring boards and research ethics boards can make sense of the findings and this latest, tragic development,” he said.
There is no proven treatment for the condition, which can have serious impacts on the child, from miscarriage or neonatal death to neuro-disability and other lifelong health risks.
The Dutch study began in 2015 and involved 183 women. Among the 93 women taking sildenafil, 19 babies died — 11 of them due to a form of high blood pressure in the lungs that researchers believe was linked to sildenafil. In the placebo group, nine babies died but none from the lung condition.