Drug Development, Results, Setbacks

With mothers on erectile dysfunction drug, 11 newborn babies die after trial triggers lung problems

A clinical trial in the Netherlands has gone horrifyingly south, with news this morning that 11 newborn babies have died after their mothers took a drug best known for erectile dysfunction during pregnancy.

The drug was a generic form of sildenafil, which works by dilating the blood vessels. The branded version of this drug is Viagra, but Pfizer was quick to note it had no involvement with this study. More on that later.

The study was initiated by researchers at the Amsterdam University Medical Center. They reasoned — and had animal evidence to hope —  the drug might boost the growth of babies who weren’t developing well in the womb by encouraging better blood flow through the placenta.

The trial was terminated last week, however, when an independent committee found that a troubling number of babies were being born with lung problems. The trial, led by Amsterdam University Medical Centre, included 93 women on the drug. Seventeen of the babies developed lung problems, and 11 have since died. Of the 90 women in the control group on placebo, 3 babies developed the same lung problems but no babies died.

Pfizer blasted statements out to all media who picked up on this story, noting that they had no involvement.

“Pfizer was not involved in any aspect of this trial, and neither funded nor provided product for the trial,” the company said in a statement. “In addition, the principle investigators at the Amsterdam University Medical Centre have confirmed a non-Pfizer manufactured generic version of sildenafil was used but that no clinical trial participants were administered Viagra, Pfizer sildenafil or any other Pfizer medicine.”

Sadly, somewhere between 10 and 15 Dutch women are still waiting to find out if their child has been affected by the drug. It is feared the drug caused high blood pressure in the lungs, leading to the babies receiving too little oxygen.

The hospital said this in a statement to The Guardian:

An interim analysis by Amsterdam UMC, location AMC, showed that sildenafil may be detrimental to the baby after birth. The chance of a disease of the blood vessels of the lungs appears to be greater and the chance of death after birth seems to have increased. The researchers found no positive effect for the children on other outcomes. All adverse effects occurred after birth. Based on these findings, the study stopped immediately. All participants were approached personally and almost everyone was informed and know by now whether they have taken the drug or the placebo.


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 33,300+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Clinical Scientist
Molecular Templates Jersey City, NJ
Manufacturing Associate - GMP Upstream
Molecular Templates Austin, TX
Director, Regulatory Affairs
Molecular Templates Jersey City, NJ
GMP Supervisor - Downstream
Molecular Templates Austin, TX
Manufacturing Associate - GMP Downstream
Molecular Templates Austin, TX

Visit Endpoints Careers ->