Dutch trial with Viagra halted after 11 babies die

Share
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.

Share

Advertisement

Related Posts

South Africa has no money for crucial nuclear energy project
He said much of the discussions with China would likely focus on what is happening with the United States. South Africa is interested in realizing a large-scale nuclear project with Russian Federation .

Jurgen Klopp responds to Jose Mourinho's mind games
And Klopp knows exactly where his Liverpool side must do better if they're going to manage that. And that's it in this year where obviously a few things happen on the goalkeeper position.

Complete lunar eclipse begins, the longest of this century
The Moon will turn red only at the highest point of the total lunar eclipse , which starts around 1 AM on the night of July 28. Unlike solar eclipses, which require protective eyewear, a lunar eclipse can be viewed without specialized eye protection.

Serena Williams hits out again at testing 'discrimination'
Maria Sharapova, who was suspended for doping when she tested positive for meldonium in 2016, doesn't have any tests on record. Individual figures for athletes tested through the Tennis Anti-Doping Programme are published at the end of each year.

Twitter shares hammered, as bad week in social media business gets worse
Global ad revenue grew 40%, to $308 million - the first time non-U.S. sales represented the majority of total ad revenue. The average estimate of 16 analysts surveyed by Zacks Investment Research was also for earnings of 17 cents per share.

Nikki Bella Planning To Move Out Of John Cena's House
We never had to go through the emotions of a breakup because I was like 'do you want to dump the guy?' Cool. I'd be like 'hello, yeah not into you, sorry.' And then I would just go on with my day, no hurt feelings.

NY moves to break up Charter’s merger with Time Warner Cable
The company said its workers "remain focused on delivering faster and better broadband to more New Yorkers, as we promised". Charter has engaged in "purposeful obfuscation" of its performance and compliance obligations, the commission said.

Disney Buys Fox in Historic $71.3 Billion Deal
Disney's and Fox's special shareholder meetings on the deal took place at New York Hilton Midtown hotel. Let us know in the comment section before Disney acquires us as well!

UK police charge 5 men in suspected acid attack on boy
Police said that the attack had targeted the child, who was accompanied by his mother, who is also from Afghanistan. Prosecutor Stephen Davies told the court that the boy and his mother were now "in a place of safety".

Donald Trump open to Moscow visit if Putin formally invites him
American politicians, including some in Mr Trump's own Republican Party, who accuse him of being too friendly towards Mr Putin. He said that, in the meantime, it's possible that he and Trump would meet during the G20 summit in Argentina in November.

© 2015 ExpressNewsline. All Rights reserved.