August 13, 2022

Generic Viagra experience linked to tragic deaths of 11 babies

Earlier this week, Amsterdam University Medical Center (UMC) announced the early termination of a clinical trial testing a new use of pharmaceutical sildenafil following newborn deaths.

The drug – known commercially as Viagra, although in this case researchers used a generic version of it, not the one produced by Pfizer – is commonly used to treat erectile dysfunction by improving circulation. blood.

Encouraged by preliminary tests, the doctors had hoped to use these same vasodilator properties to stimulate the growth of the placentas.

“We wanted to show that it was effective in promoting growth in babies,” Wessel Ganzevoort, senior researcher and gynecologist, told the daily. by Volkskrant.

“But the opposite has happened. I’m shocked. The last thing you want is to hurt patients.”

Sildenafil works by blocking an enzyme that breaks down a messenger compound that helps relax smooth muscles, such as those surrounding certain blood vessels.

The result is increased blood flow, which has utility not only in the management of erectile function, but also in reducing the severity of symptoms of mountain sickness and in the treatment of pulmonary hypertension.

Now that it is no longer under patent, the drug is being explored by research companies as a wonder drug for a range of other conditions.

One application that initially showed promise was a way to dilate blood vessels in placentas that were stubbornly slow to grow, a condition that increased the risk of premature birth and low birth weight.

“The prognosis for these babies is poor and there is no other known treatment for the child,” the UMC statement said.

Recent randomized clinical trials comparing the drug to placebo had detected no adverse effects on healthy mothers or infants, giving the green light to others to perform further testing.

In fact, the buzz about its potential has grown over the years, with rumors that doctors have already suggested pregnant women take the drug.

“Foreign colleagues have blurted out that they sometimes prescribed it, with good results,” says Ganzevoort, who was also careful to point out how more cautious Dutch doctors are.

“I have experienced in my own consultation room that pregnant women ask for it.”

What exactly happened in this trial remains a mystery.

In 2015, hospitals in the Netherlands recruited 183 women whose pregnancies were likely to be affected by placental development. About half received a placebo.

An assessment by an independent board took a closer look at 19 deaths of newborns delivered to mothers who had received the drug during their pregnancy.

Importantly, 11 of those babies were diagnosed with high blood pressure in their lungs, believed to be drug-related.

Six other newborns also suffered from a lung condition that deprived them of adequate oxygen supply, but survived.

To put these numbers in context, nine infants in the placebo group also died shortly after birth. None of them showed signs of this particular lung condition.

The study was scheduled to continue until 2020. Despite the trial being canceled, around ten women are still waiting to see how the drug might affect their pregnancy and are being closely monitored.

It is not clear where the research will go from here. The results are shocking, but also completely unexpected.

“We have to be careful at this point to find out more,” Fetal medicine expert Zarcko Alfirevic from the University of Liverpool told the BBC.

“This requires further investigation as complications were not seen in the other two similar trials which have already been carried out in the UK, Australia and New Zealand.”

Sildenafil is obviously a drug with great potential. Giving placentas a boost might still be part of it.

But it’s a tragic example of why even the most promising treatments need such extensive experimentation, no matter how promising they are.


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