Viagra Study Involving Pregnant Women Halted Amid 11 Infant Deaths
Dutch researchers have pulled the plug on a Viagra study involving pregnant women, after the drug originally intended for treatment of erectile dysfunction may have played a part in the deaths of 11 infants.
Researchers from Amsterdam Universitair Medische Centra (UMC) issued a press release (in Dutch) on July 23, announcing the immediate halt of the study, known as STRIDER, which was designed to evaluate whether Viagra (sildenafil) could improve fetal growth and birth outcomes in cases of severe restriction.
The study unexpectedly indicates that side effects of Viagra among pregnant women may be linked to the development of a blood vessel disease in the lungs, which can prove fatal after birth, according to the researchers.
The multinational, randomized clinical trial was initiated in 2015, with half of the pregnant women given a generic version of Viagra, and the other half given a placebo. At the time the Viagra study was halted, it involved about 183 women, half of whom were given the drug at centers in Amsterdam, the U.K., Canada, Australia and New Zealand.
Researchers said, however, that an interim analysis showed that Viagra increased the risk of both blood vessel disease in the lungs and the risk of death after birth, without showing any positive effects on fetal growth. The adverse effects actually made fetal outcomes worse, they determined.
As a result, the study has been stopped, and the expecting mothers have been told about the situation and whether they were given the placebo or Viagra, the researchers indicate. Children born to mothers who took the drug will be monitored.
Viagra is already prescribed “off-label” to some pregnant women to stimulate fetal growth, although that indication has not been approved by the FDA in the United States. While doctors are able to prescribe medications for any reason they believe is appropriate, researchers warn that the use of Viagra for this purpose should likely be stopped, based on the findings of this study.