[ad_1]
A study conducted in the Netherlands was stopped after nearly a dozen babies succumbed to severe lung disease. Dutch doctors were trying to determine if the active ingredient in the erectile dysfunction drug Viagra could be used to help a particular group of babies at risk. The study was led by the Amsterdam Universitair Medische Centra (University Medical Center) and followed the test protocols already carried out in New Zealand and Australia.
The Dutch study, launched in 2015, aimed at possible beneficial effects of increased blood flow to the placenta. The study followed 183 pregnant women who suffered a fetal growth restriction. Women who suffer from the condition have an underdeveloped placenta that is unable to provide enough oxygen or nutrients to a pregnant baby.
More than a dozen factors have been attributed to the development of intrauterine growth restriction, including diabetes, hypertension, and several types of infection. Infected babies are often low birth weight, may be stillborn or may have long-term growth problems that last until childhood. Low birth weight cases include about 20 million children born each year.
For the latest study, sildenafil, a generic version of Viagra, was given to 93 pregnant women to see if the drug would effectively increase blood flow to the placenta, which would provide more nutrients to babies. The 90 women in the control group received an inert placebo. At the time they were treated, the mothers did not know what treatment they were receiving, which is standard in clinical trials.
Physicians from 11 participating hospitals planned to study mothers and their children until 2020. However, 19 babies born to women treated with sildenafil died shortly thereafter after birth. Eleven of these babies died of a form of high blood pressure in the lungs. Six other babies suffered from the complication but survived.
Among the control group, only three babies had pulmonary problems and none died. About 15 women who have taken the drug have not yet given birth. Amsterdam UMC said in a statement. "Based on these results, the study halted immediately." There were no similar problems found for babies in previous studies. According to the release, the development of children in the interrupted study will continue to be monitored and the data analyzed further.
In a statement, Pfizer, the maker of Viagra, said the company had nothing to do with the lawsuit. The statement reads as follows: "Pfizer has not participated in any aspect of this trial and has neither funded nor provided any product for the trial. University of Amsterdam confirmed that a generic version of sildenafil not manufactured by Pfizer was used, but that no participant in clinical trials received Viagra, Pfizer sildenafil or any other drug Pfizer. "
Source link
