Death of babies stops Amsterdam UMC study on Viagra

The drug is sometimes recommended abroad to pregnant women to promote growth of underdeveloped foetuses, but is not common practice in the Netherlands. The study conducted by the UMC was intended to investigate the effect of such application. ‘An interim analysis at Amsterdam UMC showed that sildenafil may be detrimental to the baby after birth’, a press release states. ‘Upon treatment, there appears to be a greater chance of a disease of the blood vessels of the lungs and the chance of death after birth seems to have increased.’

The research, which started in 2015, was conducted in ten Dutch hospitals. It was half-way completed. When the study stopped last week, 183 women were involved. 93 of these had taken the drug and the rest had received a placebo. The last participants took the Viagra last Thursday and another 180 women were expected to participate in the future.

Of the 93 who took the drug, 19 babies died. Eleven of these are thought to have developed lung disease. Six other babies in this group also diagnosed with lung disease survived. In the placebo group, nine babies died—although not from disease of the lung. A further three babies in this group were diagnosed with lung disease but have survived.

Shocked

Wessel Ganzevoort of the Amsterdam UMC was the principal investigator. ‘We wanted to prove that this drug can be effective in promoting the growth of a baby’, he states in Dutch national newspaper de Volkskrant. ‘But the opposite has happened. I am shocked. The last thing you want is to harm patients.’

A previously conducted study in Britain found no advantages when the drug was applied in these circumstances he says, but also no disadvantages. ‘Now we know that the drug is damaging. This is very important. I hope patients will not be discouraged by what happened and know that the study was not conducted in vain. Now we can prevent harmful drugs reaching the market.’

The UMC has reached out to all participants and is providing support and guidance. The Healthcare and Youth Inspectorate has also been informed.