Dutch trial with Viagra halted after 11 babies die

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Dutch trial with Viagra halted after 11 babies die

There are more than a dozen women who were prescribed drugs before the trial was halted who are waiting to see if the drug had an adverse effect on their pregnancy.

The test ran in 10 Dutch hospital and involved 183 women. The trial used a non-Pfizer manufactured generic version of the drug.

A team led by Kenneth Lim at the University of British Columbia is part of an worldwide research effort looking at the effectiveness of sildenafil, the generic name of Viagra, in treating women with a condition called early-onset intrauterine growth restriction.

Ninety-three women were given Viagra in the trial, with 17 of their babies born with lung problems. Of the treatment group, eight babies died from unrelated conditions, as did nine babies in the control group.

Recent randomised clinical trials comparing the drug with a placebo had detected no adverse effects on healthy mothers or infants, giving the all clear for others to conduct further testing.

'We have already notified Canadian researchers who are conducting a similar study. But the drug may have resulted in lethal damage to the babies' lungs.

Nineteen babies born to the women treated with the drug died, 11 of them due to the lung disorder. None of these babies had developed the lung disease.

At that time, in 2010, researchers said the treatment should be used only in trials. This is in line with the conclusion by the authors of the United Kingdom study, which recommended that "clinicians worldwide should stop prescribing sildenafil for this indication outside of research studies with explicit participants' consent".

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

There is always a risk in clinical trials, however, says Indira van der Zande, who recently finished her Ph.D. thesis on pregnant women in clinical research at the University Medical Center Utrecht in the Netherlands.

Low birth weight contributes to 60% to 80% of neonatal deaths worldwide, according to the World Health Organization. It was sildenafil, the active ingredient in many erectile dysfunction drugs.

In a statement, Pfizer, the makers of Viagra, said they were not involved in the trial, "and neither funded nor provided product for the trial".

An evaluation carried out by an independent board took a closer look at 19 deaths of newborns delivered to mothers who had received the medication during their pregnancy. The doctors decided that the child would be better to stay and develop inside the mother.

The study is part of broader research in Australia, New Zealand and the UK.

A second trial with the same drug in Canada has also been paused, though there is no indication anyone there has been harmed.

32-year-old Vicki bradco English, Manchester gave birth to twins with a difference in 12 days.

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