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Dutch researchers stopped a clinical trial due to the death of 11 babies with pulmonary disease after their mothers were treated with the drug Sildenafil, commonly sold as Viagra and Revatio, during pregnancy, announced Monday the University Center of Amsterdam. The mothers participated in a clinical trial to evaluate the safety and effectiveness of the drug against erectile dysfunction in babies who had severe fetal growth problems and who could be stillbirths or die after birth. clinical trial protocol.
Half of the 183 mothers in the trial had been treated with sildenafil while the other half were treated with placebo. At the time they were treated, the mothers did not know what treatment they were receiving, which is standard in clinical trials.
"Fetal growth restriction occurs when the fetus does not get enough nutrients or oxygen from the placenta," says Dr. Mohan Pammi, neonatologist, medical director of the Neonatal Intensive Care Unit of the Texas Children's Pavilion for Women in Houston, who did not participate in the Dutch study
sometimes because the mother suffers from hypertension, uncontrolled diabetes or a condition called preeclampsia, at- he adds. 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 up blood vessels in the placenta and may help" Dutch researchers found that sildenafil was associated with babies developing disease of the blood vessels in the lungs and with an increase the risk of death after birth. The condition is essentially a type of high blood pressure in the lungs.
A similar British trial, the results of which were published in December, found no difference in neonatal deaths, and no adverse effects were associated with the drug. But this trial also showed no benefit.
Arterial hypertension in the pulmonary vessels has been associated with low birth weight, notes Pammi
. clinical trial on 11 sites in the Netherlands since its launch in 2015. Ninety-three women were treated with this drug and 90 were treated with placebo, or a dummy pill.
Nineteen babies born with treated women died, 11 of them due to pulmonary disorder. 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 treated with placebo, and they all survived.
The statement from the medical center indicates that sildenafil is sometimes used to treat women whose babies are not growing well and notes that the practice will probably be discontinued. This is consistent with the conclusion of the authors of the British study, which recommended that "clinicians worldwide stop prescribing sildenafil for this indication outside of 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 Pfizer has no involvement in the lawsuit." She reported the questions to the researchers.
»Principal Investigators at the Medical Center of the University of Amsterdam confirmed that a generic version not prepared by Pfizer of sildenafil was used, but that no participant in clinical trials has not been administered. Viagra, Pfizer sildenafil or any other Pfizer medication, "the report said.
Low birth weight contributes to 60% to 80% of neonatal deaths worldwide, according to the US Department of Health. World Health Organization.His global prevalence is 15.5%, or about 20 million children born each year, but the vast majority of low birth weight cases – 96.5% – are in the developing countries.
Children's development in interrupted study will continue According to the medical center, the clinical trial of sildenafil is also underway in the United Kingdom, Canada, Australia and Australia. New Zealand
Katie Groom, associate 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 the deaths have not been observed, nor in the United Kingdom, although they are all examining 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 who was currently in the trial, ordering her to stop taking the drug or placebo. We will be contacting the 20 other Canadian women who have already participated in the trial, "Lim wrote in an email.
Groom said the search teams at all locations will continue to explore our data in as much detail as possible within the consortium. "
She noted that the drug is used to treat pulmonary hypertension, defined by the American Heart Association as high blood pressure in the heart-to-lung system, to so "at first glance, it may seem unlikely that sildenafil caused this problem. However, 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 complication."
"Viagra is indicated for the treatment of symptoms of erectile dysfunction in adult men (18 years of age and older) .The safety and effectiveness of Viagra have been well documented in clinical studies involving more of 15,000 patients, "Pammi said in a statement.
Pammi said that there are reasons to wonder if and how sildenafil could be responsible for deaths and lung infections. Dutch study, it is possible to look at the doses received by mothers, the timing and the differences in medical care provided to women in the Netherlands compared to other countries
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