Health Care

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

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

"They temporarily stopped", - said the leader of the study, gynecologist Wessel Ganzevoort.

It comes after the Netherlands trial saw more than twice the number of mothers on the drug lose babies, than those on the placebo. A data and safety monitoring committee, however, had looked at the unblinded evidence halfway through the study and wanted to talk. However, the Dutch study was investigator-initiated, and Pfizer has no involvement in the trial, a Pfizer spokesperson told us. Because previous studies had not shown any major side effects, Ganzevoort expected the former. There were only three cases of the condition in the placebo group and no deaths.

The research was carried out at 10 hospitals across the Netherlands and involved women whose placentas had been underperforming.

Professor Zarko Alfirevic from the University of Liverpool, who led part of the United Kingdom research into sildenafil in pregnancy, said that the findings in the Dutch study were "unexpected". The condition is essentially a type of high blood pressure in the lungs.

More than a dozen things can cause intrauterine growth restriction, including maternal diseases like diabetes or high blood pressure, chromosomal abnormalities in the baby or several types of infection. At the time they were treated, the mothers did not know which treatment they were receiving, which is standard in clinical trials.

'All participants were approached personally and nearly everyone was informed and know by now whether they have taken the drug or the placebo'.

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. Yet it is not approved for such use in pregnant women by any regulatory body, so physicians have been using it in a so-called off-label manner.

Pills of the drug Viagra made by Pfizer are shown in this file
Pills of the drug Viagra made by Pfizer are shown in this file

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

The studies began in 2015, and even before last week's dramatic decision, the results so far had been disappointing.

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

In these women, the compromised placenta was affecting the growth of the foetuses in the womb.

According to doctors, a provisional analysis showed that Viagra "might be detrimental for babies after birth". "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".

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



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