Babies die after mums given Viagra in Dutch trial

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'The chance of a disease of the blood vessels of the lungs appears to be greater and the chance of death after birth seems to have increased.

The study was conducted on 93 women in 10 hospitals in all Netherlands.

Viagra was originally developed by Pfizer but is now off patent and available as a generic.

Of the group, 9 babies that died soon after birth were from mothers in the placenta group and did not show any signs of lung problems. In this group, three infants were born with lung involvement, none of them died. A further eight babies in the trial died of unrelated conditions. British researchers who were part of the same worldwide collaboration as the Dutch and Canadians reported that sildenafil "did not prolong pregnancy, improve survival, or reduce short-term neonatal morbidity".

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The drug causes increased blood pressure in the lungs. Ganzevoort, who's at the Amsterdam University Medical Center (AUMC), knew that probably meant one of two things: Either the drug worked so well that continuing to give a placebo to half of the mothers in the trial would be unethical, or the study had to be stopped because sildenafil was causing serious complications.

At the moment when the trial was stopped last week, a total of 93 women had been given Viagra to take during their pregnancy, while 90 others were given a placebo. Six babies were born with the lung disorder and survived.

AMSTERDAM-When gynecologist Wessel Ganzevoort received a request for an urgent meeting from the independent committee watching over his clinical trial last week, he thought it might be good news.

The Dutch component involved some 183 pregnant women who suffered from fetal growth restriction, where an underdeveloped placenta can't get enough oxygen or nutrients to a gestating baby.

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Researchers said their principle goal now is to find out what happened. Spokeswoman Dervila Keane wrote in an email Tuesday that the research is "an investigator initiated study and Pfizer have no involvement in the trial".

Health Canada said in an emailed statement that it has contacted the University of British Columbia concerning the Canadian trial. Its worldwide prevalence is 15.5%, comprising about 20 million children born each year, but the vast majority of low-birth-weight cases - 96.5% - are in developing countries.

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.

"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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