Viagra: fatal for the unborn

[Quartz]

Eleven children have died from lung development issues after their mothers took part in a medical trial during pregnancy.

Viagra, which dilates the blood vessels, is used for erectile dysfunction in men and is prescribed for people with high blood pressure. The hope, backed up by experimental research on rats, had been that the drug would encourage a better flow of blood through the placenta, promoting the growth of the child.

The pregnant women taking part in the trial all had unborn babies whose growth had been severely limited in the womb. The children’s prognosis, given a lack of available therapy, was regarded as being poor as a result.

The trial was terminated last week when an independent committee overseeing the research discovered that more babies than expected were being born with lung problems.

I’m glad the trial was being monitored so closely that they were able to stop it so quickly but there are still eleven heartbroken families.

[CookingWithGas]

I am not in that field but I am shocked that such a trial was performed on pregnant women without other nonhuman trials first, or something on a small scale, or more carefully controlled study before performing trials. I do not know what the ethical standards are for such studies.

[Quartz]

@CookingWithGas

I am not in that field but I am shocked that such a trial was performed on pregnant women without other nonhuman trials first,

The article says that there was a prior study, done on rats.

[RTFirefly]

Boy howdy, what a slanted OP.

From the link:

The pregnant women taking part in the trial all had unborn babies whose growth had been severely limited in the womb. The children’s prognosis, given a lack of available therapy, was regarded as being poor as a result.

So it wasn’t like these were healthy babies that were killed by Viagra. They were very unhealthy babies that they were hoping the Viagra would help - unhealthy enough that 17 of them (~1/10) died of unrelated conditions, between the experimental and control groups:

In total, 93 women were given the drug as part of the trial, led by Amsterdam University Medical Centre. Seventeen babies developed lung problems, and 11 have since died. A further eight babies died of unrelated conditions.

Of the 90 women in a control group, who took a placebo, three developed the same lung issues but no babies died from conditions that could be linked to the viagra. Nine babies did die from unrelated problems.

Clearly the Viagra experiment backfired. The size of the experimental group seems awfully large for the first human trial, but that’s the only thing I’d question.

[naita]

@RTFirefly

Clearly the Viagra experiment backfired. The size of the experimental group seems awfully large for the first human trial, but that’s the only thing I’d question.

I read this part to mean it was not the first human trial.

A trial in the UK, from which results were published last December, offered no convincing evidence either way to the drug’s efficacy, or suggested there was any risk to patients.

[naita]

Here’s the relevant bits from the background in the actual study description:

Although the number of women using sildenafil in pregnancy is low, it is increasingly used in pregnancy for maternal cardiac indications with no reports of adverse maternal or fetal effects [14, 15, 16, 17, 18, 19, 20, 21]. In a small randomised clinical trial in women with early onset pre-eclampsia, sildenafil use had no demonstrable effect on prolongation of pregnancy, but provided further reassurance on drug safety profile in pregnancy [16]. Sildenafil has been used in a small cohort of women in the setting of early onset FGR. In an observational study by STRIDER collaborators in Vancouver, Canada, there was a tendency towards more live-born children with survival intact to primary discharge for women treated with sildenafil when compared to women with pregnancies at similar risk but not receiving sildenafil [17]. From the limited observations to date there are no concerns of adverse maternal, fetal, neonatal, or infant effects associated with sildenafil use in pregnancy [14, 15, 16, 17, 18, 19, 20, 21].

On the basis of this preliminary research, some centres have already adopted treatment with sildenafil [18, 19]. However, there is no clear evidence of true health benefits and, more significantly, potential harm has not yet been excluded.

Lots of medications are used on pregnant women without studies done at all, because of the great difficulty in creating an ethical design. Despite the tragic outcomes this study seems to be a well designed one.