11 babies die after impotence drug trial on pregnant women

A drug trial that saw pregnant women giving sildenafil was stopped after 11 babies died from drug-related complications.

As part of the scheme conducted by Amsterdam University Medical Center, pregnant women whose placentas were underdeveloped in the uterus. and had a high probability of preterm delivery took sildenafil.

Sildenafil is a treatment for erectile dysfunction in men that dilates blood vessels. The drug is also prescribed to treat high blood pressure.

The hope was that sildenafil would encourage blood flow to the placenta, subsequently promoting increased growth of the child – as supported by experimental research conducted on laboratory rats.

However, the trial, conducted in 10 hospitals in the Netherlands, was terminated when an independent committee discovered that more babies were dying after birth because of lung problems compared to babies born of women taking the placebo.

According to Marc van den Broek, a spokesperson for Amsterdam UMC who spoke to The Independent all women involved in the study had a "very low birth rate" and the children would be in intensive care after birth.

Of 93 women who received sildenafil in the trial, 17 babies developed lung problems, 11 of which have died since. In comparison, of the 90 women in a control group who took the placebo, only three developed the same lung problems. No babies died of conditions that were related to sildenafil, however, nine died of unrelated problems.

Still 10-15 women still waiting for results

Although the results of the completed test have not been confirmed, it is believed that the drug has caused high blood pressure in the lungs, resulting in an insufficiency of blood pressure. oxygen in the deceased babies.

Van den Broek stated that babies developed "severe lung problems" and that the study results were published after women were informed.

A statement released by the hospital said: "An interim analysis by Amsterdam UMC, sildenafil may be detrimental to the baby after birth.The likelihood of a disease of the blood vessels of the lungs appears to be more great and the risk of death after birth seems to have increased.

"The researchers found no positive effect for the children on other findings. All adverse effects occurred after birth … Based on these findings, the study stopped immediately. All participants were personally approached and almost everyone was informed and now knew if they had taken the medication or the placebo. "

Similar studies on the effects of sildenafil on pregnant women were conducted in the United Kingdom by the University of Liverpool, New Zealand by the University of Auckland but the results of these studies were inconclusive

An ongoing study in Canada was also stopped after 11 deaths.

Before the trial, some doctors prescribe sildenafil to pregnant women. De Volkskrant, the gynecologist and chief investigator of the anti-doping trial, Wessel Ganzevoort, said: "There was agitation in the conferences." Foreign colleagues suggest that they sometimes prescribed, with good results. "

On the request for sildenafil from women with underdeveloped fetuses, Mr. van den Broek said:" They are happy with anything that could help. the study helps despite the result very sad because it helps prevent more babies from dying while women are pregnant. "

Although it is thought that the trial, which began in 2015 and was scheduled to end in 2020, is waiting for an external investigation to be launched.