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11 babies die after pregnant women have received Viagra in the Dutch study



A clinical study in the Netherlands examining the efficacy of Viagra in pregnant women whose fetuses had growth problems was stopped after the death of 11 babies. The researchers say it seems that the drug that stimulates blood flow could have caused damage to the baby's lungs that eventually led to their death.

"Based on these findings, the study stopped immediately," it says in Amsterdam University Hospital. "All participants were personally addressed, and almost all of them were informed and now know if they took the medicine or placebo, and all affected women will be accompanied as well as possible by the physicians involved in the study."

The research, conducted in 1

0 hospitals throughout the Netherlands, involved 183 pregnant women whose babies had a strong growth restriction at the beginning of pregnancy. There is no known therapy that would help these babies to grow and their prognosis was considered poor. But researchers believed that sildenafil, also known as Viagra, could help stimulate blood flow in the placenta.

Previous clinical trials in the United Kingdom, Australia and New Zealand found no evidence that the intervention was harmful. However, they did not document any benefits. By the time the earlier studies were published in 2010, researchers said that treatment should only be used in studies, BBC News.

In the Dutch study, 93 women received sildenafil and 90 a placebo drug. Of the sildenafil group, 19 babies died. Eleven of these deaths were due to a possible lung disease, a form of high blood pressure in the lungs. Six other babies in the group suffered from this lung disease, but did not die.

In the placebo group, nine babies died, none of the lung disease. Three infants in the placebo group suffered from lung disease but did not die from it.

In their statement, the Amsterdam UMC says that the "undesirable effects" found thus far are unknown. The researchers expect the use of sildenafil for this application will cease worldwide. "

According to The Guardian, the gynecologist Wessel Ganzevoor, who led the research, told the Dutch daily De Volkskrant:" We wanted to show that this is an effective way of growing but the opposite is happening. I'm shocked. The last thing you want is to harm patients.

Researchers say they will further analyze the data and closely monitor the children in the study.

Professor Zarko Alfirevic of the University of Liverpool, who led a section of British research on sildenafil in pregnancy, said that the results in the Dutch study are "unexpected."

"We need to be careful at this point to find out more," he told the BBC. "It needs a thorough investigation because of the complications in the other two, similar ones Studies that have already been done in the UK and Australia and New Zealand have not been seen. "

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