Eleven babies dead after Dutch viagra trial
pharmafile | July 25, 2018 | News story | Research and Development | Netherlands, clinical trial, deaths, premature, viagra
A trial of the drug sildenafil, commonly sold under the brand name Viagra, has been halted immediately after the death of 11 babies.
The trial, which had been carried out in 10 hospitals across the Netherlands, was stopped on Monday after 17 babies were born with lung conditions and 11 had died. In comparison, of those 90 babies in the control group, three were born with lung conditions while none died from conditions that have been linked to the use of sildenafil. Fifteen of the expectant mothers are still waiting to give birth and thus to find out whether their children have been affected by use of the drug.
Approximately half of the 183 expectant mothers involved in the study were given sildenafil in an effort to promote blood flow to the placenta. While the increased blood flow was intended to promote growth in unborn babies who were severely underdeveloped, it is suspected that the drug may have caused high blood pressure in the lungs which thus led to the babies receiving too little oxygen.
The Amsterdam University’s Academic Medical Centre (AMC) said in a statement: “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.”
The study, which began in 2015, was set to run until 2020. However the Dutch trial has been ended and Canadian researchers who are undertaking a similar study have been notified. The Canadian team have also temporarily halted their research.
Wessel Ganzevoort, who led the research, said in an interview with the Dutch daily newspaper De Volkskrant: “We wanted to show that this is an effective way to promote the growth of the baby. But the opposite happened. I am shocked. The last thing you want is to harm patients. We have already notified Canadian researchers who are conducting a similar study. In any case, they have temporarily stopped their research.”
A similar study, conducted last year in the UK, offered no convincing evidence of sildenafil’s efficacy in promoting growth in underdeveloped babies. However the study did not indicate any particular risk to patients either.
A spokesperson for the AMC commented: “An interim analysis by Amsterdam UMC, location AMC, showed that sildenafil may be detrimental to the baby after birth. 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 researchers found no positive effect for the children on other outcomes. All adverse effects occurred after birth … Based on these findings, the study stopped immediately. All participants were approached personally and almost everyone was informed and know by now whether they have taken the drug or the placebo.”
Louis Goss
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