11 babies die after pregnant women received Viagra in a Dutch study

    Abdulaziz Sobh

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    A Dutch trial with sildenafil, sold under the brand Viagra, was stopped immediately after 11 babies died of mothers who used the drug, one of the participating hospitals said on Tuesday.

    When the trial was suspended on Monday, about half of the 183 participating pregnant women took sildenafil, said the Academic Medical Center of the University of Amsterdam (AMC).

    The study began in 2015 and involved 11 hospitals. It was designed to observe the possible beneficial effects of increased blood flow to the placenta in mothers whose unborn babies were severely underdeveloped.

    About 15 women who took the medication have not yet given birth.

    "Previous studies have shown that sildenafil would have a positive effect on the growth of babies, the first results of the current study showed that there may be adverse effects for the baby after birth," said the AMC.

    However, the results showed that 17 babies were born with lung diseases and 11 died. Among the approximately equal control group, only three babies had lung problems and none died.

    Among women who took sildenafil, 11 of the babies died due to "a possibly related lung condition" that caused high blood pressure in the lungs and may have resulted from reduced oxygen levels.

    An intermediate analysis found that the likelihood of disease of blood vessels in the lungs "appears to be greater and the possibility of death after birth appears to have increased. The researchers found no positive effect for children on other outcomes," said AMC.

    Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said that the small number of trials with pregnant women has limited our knowledge of medications in pregnant women.

    "There have been other studies in this area, including preliminary work with animals and the use of pregnant women, and there are no indications that the treatment is dangerous based on previous research," he said.

    The medication was originally developed by Pfizer but is now out of patent and available as a generic. Pfizer did not have immediate comments.