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Half of the 183 mothers in the trial had been treated with sildenafil while the other half had received a placebo. At the time they were treated, the mothers did not know what treatment they were receiving, which is standard in clinical trials. "The restriction of fetal growth occurs when the fetus does not get enough nutrients or oxygen from the placenta," said Dr. Mohan Pammi, neonatologist, medical director of the Texas Neonatal Intensive Care Unit. Children's Pavilion for Women in Houston. was not involved in the Dutch study.
It happens sometimes because the mother has high blood pressure, uncontrolled diabetes or a condition called preeclampsia, he added. And babies born too small can experience a host of problems, including smaller sizes, lack of blood circulation in the intestines and death.
The hope was that the drug "may open some blood vessels in the placenta and may help the fetus grow," said Pammi.
But Dutch researchers have found that sildenafil was badociated with infants developing a disease of the blood vessels in the lungs and with an increased risk of death after birth.The condition is essentially a type of high blood pressure in the lungs.
According to the statement of the University Medical Center of Amsterdam, 1 83 women participated in the clinical trial at 11 sites in the Netherlands. it started in 2015. Ninety-three women were treated with this drug, and 90 were treated with placebo, or a dummy pill.
Nineteen babies born to women treated with the drug died, 11 of them. Six babies were born with the lung disorder and survived. In comparison, nine babies born to women treated with placebo died, but none of them had pulmonary disorder. Three babies with lung disorder were born to women who were treated with placebo, and they all survived.
The statement from the medical center indicates that sildenafil is sometimes used to treat women whose babies do not seem to be growing well and notes that the practice will probably be interrupted. This corresponds to the conclusion of the authors of the British study, which recommended that "clinicians worldwide stop prescribing sildenafil for this indication outside research studies with the explicit consent of participants."
Pfizer holds the patent until December. Spokesperson Dervila Keane wrote in an email on Tuesday that the search is "an investigation initiated by an investigator and that Pfizer has no involvement in the trial". She reported the questions to the researchers.
The company also issued a statement Wednesday noting that she did not fund or provide drugs for the trial.
"The Principle Investigators of the Medical Center at the University of Amsterdam confirmed that a generic version of non-Pfizer sildenafil was used but that no clinical trial participant was found. 39, received Viagra, Pfizer Sildenafil or any other Pfizer drug ".
The development of children in the interrupted study will continue to be monitored and the data badyzed further, according to the medical center.
The clinical trial of sildenafil is also conducted in the United Kingdom, Canada, Australia and New Zealand.
Dr. Katie Groom, badociate professor of maternal and perinatal health at the University of Auckland and chief trial investigator in Australia and New Zealand, said that these lung problems and deaths therein have not been observed nor in the UK, although they are reviewing all cases in the trial to be sure.
Dr. Ken Lim, a clinical professor in the Department of Obstetrics and Gynecology at the University of British Columbia, said the trial in Canada had been suspended. The trial began in 2017 and continued to recruit patients at three locations until it was stopped after the news of deaths in the Netherlands.
"We are not aware of any increase in adverse outcomes among the 21 Canadian participants. We contacted the Canadian woman who was currently in the trial, asking her to stop taking the drug or placebo, and we will contact the 20 other Canadian women who have already participated in the trial, "Lim wrote in an email.
Groom said the research teams in all locations "will continue to explore our data with as much detail as possible within the consortium to train if this discovery is real or random".
She noted that the drug is used to treat pulmonary hypertension, defined by the American Heart Association as high blood pressure in the heart-lung system, so "at first glance, it may seem Sildenafil is unlikely to have caused this problem, so it is biologically plausible that withdrawal of the drug at birth resulted in a rebound effect on the pulmonary vascular system, "which means that stopping the drug at birth may have resulted in the complication. "
" Viagra is indicated for the treatment of symptoms of erectile dysfunction in adult men (aged 18 years and older) The safety and effectiveness of Viagra have been well documented in clinical studies involving more than 15,000 patients, "said Pammi in his release.
questions about whether and how sildenafil may have been responsible for s deaths and lung problems in the Dutch study, which may involve looking more closely at the dosage received by mothers, the "
" Maybe they do something different ", he said.
Correction: An earlier version of this story reported that the study involved Viagra; However, researchers and drug maker Pfizer now say that the study was on a generic version of sildenafil.
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