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techkenyot.com September 21, 2018


11 babies die after pregnant women were given Viagra in Dutch study

26 July 2018, 05:06 | Silvia Roy

Getty Images

Getty Images

A Dutch drug trial in which pregnant women whose babies faced life-threatening growth issues were given Viagra has been halted after 11 babies died.

Amsterdam gynaecologist Wessel Ganzevoort, who led the study, told the leading Volkskrant daily that Viagra had been seen as a very promising drug to help boost growth in unborn babies. Roughly half the sample group were given placeboes.

"In light of these results from Holland, we are going to go back and discuss the matter with them and make a decision over the next one or two weeks". Why were there no similar problems for babies in the previous studies? Three others were born with a lung condition. It was created to look at possible beneficial effects of increased blood flow to the placenta in mothers whose unborn babies were severely underdeveloped.

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.

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. In spite of the trial's cancellation, around a dozen women are still waiting to see how the drug could affect their pregnancy, and are being closely monitored. But they also found no benefit.

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High blood pressure in the lungs' vessels has been linked to low birth weight, Pammi noted.

"Based on these findings, the study stopped immediately", according to a statement from Amsterdam University Medical Center. It's feared that the drug caused blood pressure to build up in the lungs, meaning the babies received a diminishing amount of oxygen. Six babies were born with the lung disorder and survived. Only three of their children had the same lung condition, and none of them died of it.

The AMC said that sildenafil is sometimes prescribed to pregnant women in other countries whose babies face developmental delays in the womb, though this rarely occurs in the Netherlands. "The researchers expect that the use of sildenafil for this application will stop worldwide", the statement said.

Pfizer held the drug's patent until December.

The original version of this story misstated the drug involved in the study.

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Sildenafil is the active ingredient in popular erectile dysfunction medications like Viagra, but the study did not involve Viagra nor a generic form authorized by Viagra's creator, Pfizer. Study inclusion criteria in the United Kingdom, Australia, New Zealand, and the Netherlands differed slightly, but not enough to explain the varying outcomes, Groom says.

"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".

According to an update posted this month to the Canadian research group's website, 21 of the target 90 subjects have been recruited in Vancouver, Montreal and Quebec City to participate in the trial.

The spokesman said: 'The Amsterdam UMC has concluded studying the effects of the medication sildenafil, also known as Viagra, which was given to pregnant women whose foetuses showed severe growth defects'.

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