Eleven babies die after pregnant women are given erection drugs during medical trial… with up to 15 more women facing agonising wait over their babies’ condition
When the trial in the Netherlands of sildenafil - a drug for erectile dysfunction - was stopped, approximately half of 183 pregnant women participating were taking the drug
A MEDICAL drug trial of sildenafil on pregnant mums in the Netherlands has been halted after 11 babies died, one of the participating hospitals said today.
And up to 15 women who took the medication face an agonising wait over their babies' condition after taking the drug as they have yet to give birth.
When the trial in the Netherlands of sildenafil was stopped, approximately half of 183 pregnant women participating were taking the drug, the Amsterdam University's Academic Medical Centre (AMC) said.
The study - which started in 2015 and involved 11 hospitals - was designed to look at possible beneficial effects of increased blood flow to the placenta in mothers whose unborn babies were severely underdeveloped.
The AMC said: "Previous studies have shown that sildenafil would have a positive effect on the growth of babies. The first results of the current study showed that there may be adverse effects for the baby after birth."
But the results showed that 17 babies were born with lung conditions and 11 died.
Despite initial media reports, investigators at the AMC have confirmed Viagra was not used in the trial and Pfizer have said they were "not involved in any aspect of the trial".
In the roughly equal control group, just three babies had lung problems and none died.
But among the women taking sildenafil, 11 of the babies died due to "a possibly related lung condition" that caused high blood pressure in the lungs and may have resulted from reduced oxygen levels.
An interim analysis found that the chance of blood vessel disease in the lungs "appears to be greater and the chance of death after birth seems to have increased. The researchers found no positive effect for the children on other outcomes," the AMC said.
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The drug was originally developed by Pfizer but is now off patent and available as a generic.
In a statement, Pfizer said: "Pfizer was not involved in any aspect of this trial, and neither funded nor provided product for the trial.
"In addition, the Principle Investigators at the Amsterdam University Medical Centre have confirmed a non-Pfizer manufactured generic version of sildenafil was used but that no clinical trial participants were administered Viagra, Pfizer sildenafil or any other Pfizer medicine.
"Viagra is indicated for the treatment of the symptoms of erectile dysfunction in adult men. The safety and efficacy of Viagra has been well documented in clinical studies involving more than 15,000 patients.
"We wish to express our sympathy for the trial participants and their families."
Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said the small number of trials with pregnant women has limited our knowledge of medicines in pregnant women.
"There have been other studies in this area, both involving preliminary work using animals and using pregnant women, and there was no indication that the treatment was dangerous based on previous research," he said.
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