Dutch trial with Viagra halted after 11 babies die

Viagra trial baby deaths Dutch research project called off as 11 infants die

A Queensland study using Sildenafil, a drug commonly known under the brand name Viagra, on pregnant women has been temporarily halted after 11 babies died when the same drug was used by mothers in another study in the Netherlands. Previous research in rats suggested the drug might boost blood flow in the placenta and promote a baby's growth, The Guardian reported.

Huf-Germain, whose daughter was born prematurely two years ago but is now healthy, said she had been told she was on a placebo in the trial.

It is thought that the drug may have caused high blood pressure in the lungs, leading to the babies receiving too little oxygen. Three others were born with a lung condition. Among the 20 other Canadians who have already participated in the trial, researchers are not aware of any adverse outcomes. But they also found no benefit.

He said: "The likelihood of developing a lung condition was much higher (among Viagra takers), as was the chances of death shortly after birth".

Kiwi researchers are disappointed after a Dutch trial where Viagra was being administered to pregnant women, has urgently been called off. All participants in the trial have now been informed whether they were given the drug or a placebo. Of the babies born to women who received sildenafil, 17 developed lung problems, and 11 of those have died. Seventeen babies developed lung problems, and 11 died. 90 women partook in a placebo arm, in which nine babies died.

About 15 mothers in the drug trial group have yet to give birth. Women participated in a medical experiment. It is now available as a generic drug. Spokeswoman Dervila Keane wrote in an email Tuesday that the research is "an investigator initiated study and Pfizer have no involvement in the trial".

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The company also issued a statement Wednesday noting that it did not fund or provide medication for the trial.

Low birth weight contributes to 60-80 percent of neonatal deaths worldwide, according to the World Health Organization. The doctors decided that the child would be better to stay and develop inside the mother.

Doctors intend to "extensively" analyze all the data they've been able to collect so far, and "the development of the children will be closely monitored".

Earlier trials in the United Kingdom and Australia and New Zealand did not find any evidence of potential harm from the intervention.

The trial is one of four internationally, one of which was carried out in New Zealand and Australia with over 100 women. "We will continue to work with the sponsor to determine next steps, including the suspension of the trial, if necessary". Severe cases of IUGR can cause long-term developmental problems or death.

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