11 babies die after mothers take Viagra in medical study

Eleven babies are dead after women were given the erectile dysfunction medication Viagra during pregnancy as part of a drug trial in the Netherlands.

The study involving 183 pregnant women at the University Medical Center in Amsterdam was stopped following the deaths of the babies, local news agency de Volksrant reported. The purpose of the study was to see if vasodilator sildenafil, known as Viagra, would promote blood flow of the placenta, helping the baby grow.

The women in the study, which began in 2015 and was slated to run until 2020, were pregnant with babies who had severe growth deficits early in their pregnancy, between 20 and 30 weeks. As a result, the babies were given a poor prognosis. According to The Guardian, the use in this situation of Viagra, which is also prescribed for people with high blood pressure, is supported by experimental research on rats.

Doctors administered Viagra to about half the women while the others were given a placebo. Among the women who received Viagra, 17 babies developed lung problems and 11 of them died. Eight additional babies died of unrelated conditions, according to de Volksrant. Three babies in the control group developed lung problems and nine died from other causes

Between 10 and 15 women are still waiting to find out if their baby has been affected, The Guardian reported.

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Lesser-known facts about Viagra
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Lesser-known facts about Viagra

It was an accident

In the early '90s, a research team at Pfizer, Viagra's maker, was experimenting with a drug to treat thoracic pain when men in the trial were experiencing an unexpected side effect — the pill was inducing an erection. Pfizer then switched tracks and focused on its drug's potential in treating impotence, and Viagra was born. It got the green light from the Food and Drug Administration in March of 1998 and hit stores that April.

Seeing blue

One of Viagra's lesser-known effects is cyanopsia, or a blue-tinted vision. The pill is able to aid men in achieving an erection by relaxing the groin muscles enough to increase blood flow. It does this by lessening the influence of an enzyme called phosphodiesterase 5. To a lesser degree, Viagra also restricts another enzyme called phosphodiesterase 6, which is linked to rod cells in the eye — cells that are best at picking up blue light. They become more sensitive when Viagra is in the system and wash everything the user is seeing in shades of blue.

Black market darling

The “little blue pill” had immense success from the moment it was available. Within its first two weeks on sale, Viagra prescriptions in the U.S. were written 150,000 times. Black markets quickly popped up across Europe and the Middle East — a pill many men coveted, but were uncomfortable talking about.

Fast fakes

In a matter of weeks after it was made available and started selling rapidly, counterfeit versions of Viagra made in India and Thailand began popping up online. A 2011 poll from Pfizer revealed that about 80% of the pills bought online are fake — and dangerous. The phony tablets often contained toxic chemicals like pesticides, plaster and ink.

Famous fans

A number of celebrities and other famous (or infamous) men have reportedly and admittedly popped Viagra.

Actor Michael Douglas praised the pills as "wonderful enhancements." Presidential candidate Bob Dole was the drug's early spokesman in 1999, as was soccer great Pele in 2002. "The Godfather" star James Caan once said "I take a little Viagra now," in a Playboy interview and the magazine's founder, the late Hugh Hefner, touted the drug as "God's little helper," in a 2010 New York Times interview.

A prescription bottle of the impotence drug written under another name was discovered in the luggage of Rush Limbaugh when he was returning to the States from a 2006 trip to the Dominican Republic. And a form of herbal Viagra was found in 2011 at the Pakistani compound where Sept. 11 mastermind Osama bin Laden was killed.

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Leader of the study Dr. Wessel Ganzevoort told local news agency Nieuwsuur that "there is a relationship" between the deaths and the drug, but it "is not yet clear."

"It is clear that it is much more prevalent in the sildenafil group than in the placebo group, so there is a relationship, but in individual cases that is not yet clear," Ganzevoort said. "We do not know if the babies would have survived if they had not received the drug."

Researchers believe that the Viagra caused high blood pressure in the babies' lungs, leading them to not receive enough oxygen. There is no evidence that suggests the trial was mishandled, according to The Guardian.

Ganzevoort told Nieuwsuur that many questions around the study remain and the researchers will continue to monitor the surviving babies and their mothers. They also plan to pore over the files of the deceased babies and their mothers "to understand very well what precisely happened."

He added that he is "shocked" by the results and that he had hoped the treatment would lead to healthy babies.

"I do this very much, as a person and as a doctor, I know these patients and their stories well," Ganzevoort said. "You hope that the treatment will lead to more healthy babies, if you see these results then you will be very shocked."

Copyright 2017 U.S. News & World Report

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