Trial of erectile dysfunction drug on pregnant women stopped after 11 babies die

A clinical trial treating pregnant women with an erectile dysfunction drug was stopped.

Story highlights

  • The mothers were part of a trial to evaluate the drug for unborn babies with severe fetal growth restriction
  • Researchers found that sildenafil was associated with a blood vessel disease in babies' lungs

(CNN)Dutch researchers stopped a clinical trial due to the deaths of 11 babies from a lung disease after their mothers were treated with the drug sildenafil, commonly sold as Viagra and Revatio, while pregnant, Amsterdam University Medical Center announced Monday.

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.
    "Fetal growth restriction happens when the growing fetus doesn't get enough nutrients or oxygen from the placenta," said neonatologist Dr. Mohan Pammi, medical director of the neonatal intensive care unit at Texas Children's Pavilion for Women in Houston, who was not involved in the Dutch study.
    It sometimes occurs because the mother has high blood pressure, uncontrolled diabetes or a condition called preeclampsia, he added. And babies born too small can experience a host of problems, including smaller head sizes, lack of blood flow to the intestines and death.
    The hope was that the drug "can open up some blood vessels in the placenta and then can help the growth of the fetus," Pammi said.
    But the Dutch researchers found that sildenafil was associated with the babies devel