Baby deaths halt Viagra trial

A Dutch drug trial in which pregnant women whose babies faced life-threatening growth issues were given Viagra has been halted after 11 babies died.

The parents of around a dozen babies in the trial, who are as yet unborn or in intensive care, now face a nervous wait.

The women who received sildenafil – better known by its brand name Viagra – in a trial to try to stimulate their babies’ growth, were told it may have increased the risk of lung disease.

In the trial, which began in January 2015 in 10 Dutch hospitals, it was hoped the antiimpotence tablets would increase the size of the placenta and encourage foetus development.

In total, 93 women were given sildenafil and 90 were given a dummy drug or placebo. Twenty babies developed lung problems after birth – three in the placebo group and the rest in the treatment group.

Eleven in the sildenafil group died from lung complications, but a total of 17 babies in the group were diagnosed with lung disease shortly after birth.

In the control group, three babies had the same lung disease but none of them died, according to reports. In total, 19 babies who were born prematurely in the drug group died, compared with nine in the control group.

‘‘The chance of lung disease appears to be greater, and also the chance of death following the birth seems to be increased,’’ said a letter sent to the parents involved, according to Hart van Nederland, a Dutch TV programme.

Suzanne and Martijn de Lange, whose baby died, said the news had thrown them into turmoil. ‘‘We had made peace with the fact that our daughter Olivia died eight days after birth,’’ Suzanne de Lange old the NOS news channel. ‘‘The cause was natural, we thought. And we had come to terms with it. Until on Friday evening we were called by the UMC hospital in Leiden and told it might have had something to do with the study.’’

Senior researcher Wessel Ganzevoort, who is based at the AMC teaching hospital in Amsterdam, told Hart van Nederland it was focusing on supporting the parents. ‘‘I have spoken to a number of these patients and they are, of course, very emotional about this, as I am too. They knew . . . that it was uncertain, but now they have to live with the thought that they took part in something that caused potential damage. That is incredibly sad.’’

He told NOS that 10 to 15 women who took part do not yet know what the outcome will be for their baby: some are still pregnant, and several parents have babies in intensive care. He said that earlier, small-scale studies into using the drug had had positive results.

‘‘The medicine was being used in practice, but we felt it was too early to just introduce it,’’ Ganzevoort told NOS. ‘‘We wanted to do a thorough investigation first.’’

Trials in the UK, Australia and New Zealand in 2012 had found no benefit from the drug, but also no side effects.

– Telegraph Group

‘‘Now they have to live with the thought that they took part in something that caused potential damage.’’

Wessel Ganzevoort