Lessons From Fatal Viagra Pregnancy Study: Safe Natural Alternatives Should Take Priority In Clinical Trials

Many people were understandably shocked by the recent news about 11 babies who died following a clinical trial in the Netherlands in which Viagra was given to pregnant women. Not surprisingly, the distressing outcome of the trial triggered many questions about the recklessness of subjecting these women to the hazards of a pharmaceutical drug when they were already known to be at high risk of having a premature baby. Since pregnancy itself is associated with many health challenges, we have to ask whether previous anecdotal reports associating Viagra with minimal improvements in birthweight and pre-term delivery constituted sufficient grounds for using the drug in large clinical trials. This question is especially pertinent given that no benefits had been reported in an earlier clinical trial of this type. Just as importantly, were safe natural alternatives to Viagra ever even considered or discussed with the study participants?

The clinical trial in the Netherlands was one of several coordinated national and international studies testing the effects of Viagra in women whose pregnancies were at risk of slow fetal growth and pre-term delivery. But if the recommendation of an earlier study conducted in the UK had been applied, namely, that Viagra should not be prescribed in such high risk pregnancies, the tragic deaths of the 11 babies could easily have been avoided.

The Dutch Viagra study is part of a general trend in which new disease applications are being sought for existing drugs whose patent protections are soon to expire. Ultimately, the goal of studies such as these is to find ways to boost drug company profits by reaching new patient populations and markets. To the drug manufacturers, protecting human health and lives is entirely secondary to expanding markets and increasing profits.

What was the reason for using Viagra in this study?

The reason given for testing Viagra in pregnant women was to improve blood flow to the placenta by dilating blood vessels. It was anticipated by the researchers that this would increase the supply of oxygen and nutrients to the baby and, consequently, support its growth. Currently prescribed for erectile dysfunction, Viagra is used to widen the arteries and increase blood flow by enhancing the production of nitric oxide (NO) – a gas often referred to as a “relaxing factor’ – in the cells lining blood vessels. While Viagra is not approved for use in pregnancy, some doctors were apparently already prescribing it for women who had a risk of fetal growth problems or pre-term delivery. As some individual cases of improvement had been reported, clinical trials were funded in several countries as a means of justifying the marketing of the drug to pregnant women.

Because of the obvious risk of side effects and possible harm to the baby, experimental tests or treatments involving pregnant women are usually carefully evaluated in advance. However, it appears that such risks were not taken seriously in this study. Drug testing should be especially restricted in pregnancy since the attendant risks may affect both the mother and her unborn child. Moreover, any resulting health impairments may not manifest themselves until long after the child’s birth and may even go on to affect it during its adult life.

Until the monitoring of surviving children born to the mothers participating in the Dutch trials is completed, it will not be known whether the Viagra has any long-term detrimental effects on their health. Like any other drug, however, Viagra already has many known side effects. These are all available to read online. Anyone considering taking the drug should review them very carefully.

For Sildenafil (Viagra) – the drug used in the pregnancy study – the list of known side effects is very long. The most frequently reported health problems appearing in 10% or more of patients include: headache (up to 28% of patients), indigestion (up to 17%), diarrhea, sore throat (18%), flushing (10%), pain in extremities, abnormal vision (11%), stuffy nose from inflammation and irritation of mucosa, rash, alopecia, night sweats, anemia, fluid retention, cellulitis, flu, bronchitis, vertigo, insomnia and anxiety.

A list containing all of the above, plus other less frequently seen side effects, should have been presented in advance to the women planning to participate in the Dutch study. The women would then have had to sign a consent form before being allowed to take part. Assuming they saw the full list of side effects, one can only but wonder why they agreed to take the risk.

Are risk-benefit ratios always properly addressed?

Read more from the source: Lessons From Fatal Viagra Pregnancy Study: Safe Natural Alternatives Should Take Priority In Clinical Trials – Dr. Rath Health Foundation