Pharmaceutical Study Kills 11 Babies With Generic Viagra
Cory Wayne
A Dutch research team has stopped a clinical trial after 11 babies died. The babies died from lung disease, their mothers were in a clinical trial that involved taking the prescription medication, sildenafil, the popular ingredient used in Viagra and other erectile dysfunction drugs. Amsterdam University Medical Center confirmed that the clinical trial had been shut down after the deaths.
The clinical trial was using unborn babies as test subjects for sildenafil. The babies were determined to have a prior risk of severe fetal growth restriction and were noted as having the potential for a stillborn birth.
There were a total of 183 mothers in the clinical trial, but only half received the sildenafil. The other half were given a placebo. The mothers were not told whether they were given sildenafil or placebo.
A neonatologist Dr. Mohan Pammi who is the medical director of Texas Children’s Pavilion for Women in Houston told KCTV5 that “Fetal growth restriction happens when the growing fetus doesn’t get enough nutrients or oxygen from the placenta.”
It can occur due to conditions such as preeclampsia, diabetes, and high blood pressure.
The desire of the clinical trial’s was to use of sildenafil and determine if it “can open up some blood vessels in the placenta and then can help the growth of the fetus,” Pammi added.
Unfortunately, the drug was having a side effect that resulted in the babies developing a blood vessel disease in the lungs.
A prior UK trial resulted in no difference in neonatal deaths, however, the study showed no benefit in using sildenafil, either. The authors of the UK study told warned that”clinicians worldwide should stop prescribing sildenafil for this indication outside of research studies with explicit participants’ consent.”
The Dutch study began throughout Amsterdam in 2015 using 11 locations. The clinical study resulted in 19 baby deaths, but only 11 of them were due to the lung disease.
The clinical trial researchers also removed Pfizer, who has long held the patent on sildenafil, from responsibility in the matter. They claim that Pfizer did not fund the study and that a “non-Pfizer manufactured generic version of sildenafil was used” in the trial.
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