Babies Have Died During A Viagra Pregnancy Study

The Hope Was Viagra Could Help Babies. Instead, 11 Died

Between 10-15 women are now waiting to hear if their child was also affected.

"The chance of lung disease appears to be greater, and also the chance of death following the birth seems to be increased", said a letter sent to the parents involved, according to Hart van Nederland, a Dutch TV programme.

The research, carried out at 10 hospitals, involved giving the women - chosen because their placentas had been under performing - the drug sildenafil, commonly sold under the brand name Viagra.

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. Ninety-three women were treated with the drug, and 90 were treated with the placebo, or dummy pill. The trial had a group control that received placebo drugs - in that group nine babies died, but none of them had lung problems.

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A similar United Kingdom trial, the results of which were published in December, found no difference in neonatal deaths, and no adverse affects were linked to the drug.

Researchers at the University of British Columbia in Vancouver, Canada, have stopped a similar study, pending an in-depth investigation of what happened in the Netherlands.

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 the Queensland study, the drug was used over a significantly shorter time frame and for different reasons. Seventeen babies developed lung problems, and 11 died.

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SIL, aka Viagra, is a drug approved by the Federal Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of erectile dysfunction and pulmonary hypertension in adults.

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.

Low birth weight contributes to 60% to 80% of neonatal deaths worldwide, according to the World Health Organization.

Ganzevoort expressed concern that doctors may have been prescribing the medication to pregnant women after hearing anecdotal evidence it may be good for children at medical conferences. The doctors decided that the child would be better to stay and develop inside the mother. In 2012, they started an initiative to conduct five separate but very similar trials that would culminate in a meta-analysis. "It needs a thorough investigation because the complications were not seen in the two other, similar trials that have already been done in the United Kingdom and Australia and New Zealand".

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

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