Canada pulls out of international study after 11 babies die

An international study in which Canada was involved was interrupted because the drug used on pregnant women, similar to Viagra, is suspected of causing the death of 11 babies in the Netherlands.

The Stride study, conducted in a consortium of five countries, including Canada, administered pregnant women, whose babies do not grow normally, Sildenafil, a drug very similar to Viagra.

This drug was supposed to help women who had major delays in early intrauterine growth for which there is currently no treatment. By dilating the blood vessels, the researchers hoped that Sildenafil facilitates the proper functioning of the placenta.

Promising studies, including one in Vancouver, showed an encouraging recovery of growth in some babies, with no complications.

The 5 countries participating in the study

  • Australia
  • Canada
  • New Zealand
  • Netherlands
  • UK

Disappointing results

However, the results were disastrous in the Netherlands: 11 babies died as a result of this clinical trial.

“[The researchers] found more pulmonary arterial hypertension in preterm infants who were taking Sildenafil,” said Dr. François Audibert, obstetrician-gynecologist at the CHU Sainte-Justine on the program Midi Info .

The clinical trial in 10 hospitals in the Netherlands involved two groups of pregnant women. Researchers prescribed Sildenafil in the first group during pregnancy and placebo in the second group. More deaths were seen in the group taking active treatment.

“There were deaths among fetuses whose mothers took the placebo. But we are talking about mothers who are sick and especially babies who are very at risk. So, even with the placebo, babies are still at risk of dying, “says Dr. Audibert.

After seeing the deaths of these babies, studies in Canada were all stopped. The drug has not yet been directly questioned.

Are [deaths] related to this treatment or is it the effect of chance? […] This is a sufficient suspicion to stop the study immediately.

Dr. François Audibert, obstetrician-gynecologist at CHU Sainte-Justine

In a statement, the pharmaceutical company Pfizer that manufactures Viagra says “[that] iit s not involved in this study and did not provide drugs or financial support for it.”

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