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

Eleven babies die as pregnant women are given Viagra during drug trial

article image Dutch halt Viagra in pregnancy trial after 11 babies die

They're two of four global trials.

Viagra increases blood flow, and previous studies had showed the drug to improve the functioning of the placenta, the AMC said in a statement.

Crucially, 11 of those babies were diagnosed with elevated blood pressure in their lungs, presumed to be linked to the drug.

And there were "no positive effects for the children on other outcomes", the researchers concluded.

A trial in the United Kingdom, from which results were published last December, offered no convincing evidence either way to the drug's efficacy, or suggested there was any risk to patients. But they also found no benefit.

The researchers found no positive effect of the drug, the Amsterdam University's Academic Medical Center (AMC) said.

It appears the sildenafil used in the trial, which promotes blood flow, may have caused lethal damage to the babies' lungs. Six babies were born with the lung disorder and survived.

Among the roughly equal control group, just three babies had lung problems and none died.

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Doctors conceded they had more questions than answers: What about the drug had caused the babies to die? A trial in Ireland has yet to start enrollment; researchers in that study did not respond to emails today, but Mol expects it will be canceled.

Pfizer held the drug's patent until December.

In the Queensland study, the drug was used over a significantly shorter time frame and for different reasons. The trial used a non-Pfizer manufactured generic version of the drug.

It can mean babies are born prematurely, with a very low birth weight and poor chances of survival. "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".

Dr. Katie Groom, associate professor of maternal and perinatal health at the University of Auckland and the chief investigator of the Australia and New Zealand trial, said these lung problems and deaths were not seen there, nor in the United Kingdom, although they are reviewing all of the cases in the trial to be sure. A spokesman for Health Canada says the government is working with the University of British Columbia, which was sponsoring the Canadian equivalent, to figure out what to do next, "including the suspension of the trial, if necessary".

It's also unclear why the deaths happened only in the Dutch trial. "We had made peace with the fact that our daughter Olivia died eight days after birth", she told the NOS news channel. Another 90 pregnant women were given a placebo.

Groom said the research teams in all locations will "continue to explore our data in as much detail as possible within the consortium to workout if this finding is real or chance". Viagra dilates the blood vessels and is sometimes prescribed for people with high blood pressure. All adverse effects occurred after birth ...

"Viagra is indicated for the treatment of the symptoms of erectile dysfunction in adult men (aged 18 years and over)".

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