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CNN: Generic Viagra trial among pregnant women shuts down after 11 newborn deaths

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A Dutch clinical trial was recently stopped due to the deaths of 11 babies from a lung disease after their mothers were treated with the drug sildenafil, also known as Viagra, while pregnant. (Viagra is indicated for the treatment of erectile dysfunction in men aged 18 years and over.)

“The mothers were part of a clinical trial to evaluate the safety and effectiveness of the erectile dysfunction drug on unborn babies who had severe fetal growth restriction and who faced significant risk of being stillborn or dying after birth, according to a study that detailed the design and protocol of the clinical trial.

Half of the 183 mothers in the trial had been treated with sildenafil while the other half were treated with a placebo. At the time they were treated, the mothers did not know which treatment they were receiving, which is standard in clinical trials.” 1

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Fetal growth restriction happens when the growing fetus doesn’t get enough nutrients or oxygen from the placenta. But it can also happen if the mother has high blood pressure, uncontrolled diabetes or a condition called preeclampsia. Researchers were using the drug in the hopes that it would open up some blood vessels in the placenta which would then help the growth of the fetus.
However, researchers found that sildenafil was associated with the babies developing a blood vessel disease in the lungs (a type of high blood pressure located in the lungs) and with an increase in the risk of death after birth. A similar UK trial found no difference in neonatal deaths and no adverse effects but also didn’t show a benefit. There are also clinical trials of sildenafil being conducted in the United Kingdom, Canada (which has been suspended), Australia and New Zealand.
“According to the statement from Amsterdam University Medical Center, 183 women had participated in the clinical trial at 11 locations in the Netherlands since it began in 2015. Ninety-three women were treated with the drug, and 90 were treated with the placebo, or dummy pill.
Nineteen babies born to the women treated with the drug died, 11 of them due to the lung disorder. Six babies were born with the lung disorder and survived. In comparison, nine babies born to women treated with the placebo died, but none of them had the lung disorder. Three babies with the lung disorder were born to women who were treated with the placebo, and they all survived.”2
Sildenafil is sometimes used to treat women whose babies don’t seem to be growing well but after this trial, the practice will likely be discontinued, something the authors of the UK study are encouraging.
The WHO says low birth weight contributes to 60% to 80% of neonatal deaths worldwide with a worldwide prevalence of 15.5% (about 20 million children each year) but that the vast majority of low-birth-weight cases, 96.5%, are in developing countries.3
Teams will continue to monitor the development of the children in the halted study and researchers will analyze the data. In fact, the research teams in each location will “continue to explore our data in as much detail as possible within the consortium to workout if this finding is real or chance.”4
Pfizer Spokeswoman Dervila Keane said in an email that the research was investigator-initiated using a non-Pfizer manufactured generic version of sildenafil and that no clinical trial participants were administered Viagra, Pfizer sildenafil, or any other Pfizer medicine, that Pfizer had no involvement in the trial, and she deferred any remaining questions directly to the researchers. The company also said it did not fund or provide medication for the trial.

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