Viagra in pregnancy study stopped after 11 babies die

The parents of 10 to 15 babies in the trial are facing an agonizing wait to see if their infants will be affected by the drug.

The researchers say it appears the drug, which stimulates blood flow, may have caused damage to the babies' lungs, ultimately leading to their death.

"Fetal growth restriction happens when the growing fetus doesn't get enough nutrients or oxygen from the placenta", said neonatologist Dr. Mohan Pammi, medical director of the neonatal intensive care unit at Texas Children's Pavilion for Women in Houston, who was not involved in the Dutch study.

A team led by Kenneth Lim at the University of British Columbia is part of an worldwide 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. "17 children have developed lung problems, and 11 died", - stated in the message.

Of the 90 women in a control group, who took a placebo drug, three developed the same lung issues but no babies died.

"As a precautionary measure, we have paused recruitment into our trial, until we have an opportunity to gain further information".

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

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An independent committee overseeing the research halted the trial after discovering that a number of babies were being born with lung problems, The Guardian said. 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. The trial was testing the use of the pharmaceutical sildenafil in assisting placenta growth. Six other babies also had the same lung condition but survived.

Mr Kumar said a decision on the future of the Queensland study would be decided within a fortnight and, in the meantime, they have stopped recruiting mothers for their research. 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.

The trial has now been cancelled and an investigation is ongoing.

According to the statement from Amsterdam University Medical Center, 183 women had participated in the clinical trial at 11 locations in the Netherlands since it began in 2015. It was sildenafil, the active ingredient in many erectile dysfunction drugs.

"We are not aware of an increase in adverse outcomes among the 21 Canadian trial participants".

About 230 women had enrolled in the Mater trial, with another 200 expected to be recruited before the study was halted.

The study is part of broader research in Australia, New Zealand and the UK.

(Copyright © 2015. All Rights Reserved.)
 
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