Drug trial on pregnant women halted after 11 babies die

July 25, 2018

A Dutch hospital is stopping a clinical trial involving sildenafil, a generic Viagra, on pregnant women.

The trial, which started in 2015, had aimed to see if sildenafil could dilate blood vessels and deliver more oxygen and nutrients to poorly developing fetuses. Over 180 women in 11 different hospitals in the Netherlands were enrolled in the study — about half were given Viagra and the other half received a placebo. 

Last week, an independent committee monitoring the study reported that 17 fetuses in the Viagra group developed persistent pulmonary hypertension — and 11 of them died. The same condition developed in 17 fetuses in the placebo group, but there were no deaths.

Pfizer, which manufactures Viagra, issued a statement saying it played no role in the study.

Similar studies in the past had not shown this type of adverse reaction, but they had not yielded encouraging results either. The decision to halt this trial is likely to deliver a blow to the hope that Viagra could be used for this indication.

Read the full USA Today report.