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The study with Viagra in pregnant women was discontinued after 11 babies died



Dutch researchers stopped a clinical study on the death of eleven infants from lung disease after their mothers were treated with the drug sildenafil, commonly known as Viagra, the Amsterdam University Hospital announced on Monday.

The mothers were part of a clinical study evaluating the safety and efficacy of the drug in unborn babies who had severe fetal growth restriction and who were at significant risk for stillbirth or dying after birth, according to a study Study and protocol of clinical study performed study

Half of the 183 mothers in the study were treated with sildenafil while the other half were treated with placebo. By the time they were treated, the mothers did not know what treatment they were given, which is standard in clinical trials.

"Fetal growth restriction occurs when the growing fetus does not get enough nutrients or oxygen from the placenta," said neonatologist Dr. Mohan Pammi, medical director of the Neonatal Intensive Care Unit at the Texas Children's Pavilion for Women in Houston, who was not involved in the Dutch study.

It sometimes happens because the mother has high blood pressure, uncontrolled diabetes or a condition called preeclampsia, he added. And undersized babies can experience a variety of problems, including smaller head sizes, lack of blood flow to the gut, and death.

The hope was that the drug "can open some blood vessels in the placenta and then help" the growth of the fetus, "said Pammi.

But the Dutch researchers found that sildenafil was associated with the babies The condition is essentially a type of high blood pressure in the lungs.

A similar UK study, the results of which were published in December, found none Difference in neonatal deaths, and no adverse effects were associated with the drug, but even this trial was of no use.

High blood pressure in the pulmonary vessels has been associated with low birth weight, Pammi noted.

Amsterdam University Hospital had 1

83 women participated in the clinical study at 11 sites in the Netherlands anden since the beginning in 2015. Ninety-three women were treated with the drug and 90 were treated with the placebo or dummy pill.

Nineteen babies of the women who were treated with the drug died, 11 of them due to the lung disease. Six babies were born with the lung disease and survived. In comparison, nine babies of placebo-treated women died, but none of them had lung disease. Three women with lung disease were born from placebo-treated women and all survived.

The statement by the medical center said Sildenafil is sometimes used to treat women whose babies do not seem to grow well and have noticed this The practice is likely to be discontinued. This is in line with the conclusion of the authors of the UK study, which recommends that "clinicians worldwide should stop prescribing sildenafil for this indication outside of research studies with the explicit consent of participants."

The drug is manufactured by Pfizer; Spokeswoman Dervila Keane said in an email that the research is "a research-led study and Pfizer is not involved in the study." She asked all the questions to the researchers.

Low birth weight contributes to 60% to 80% of neonatal deaths worldwide, according to the World Health Organization. Its worldwide prevalence is 15.5% and includes approximately 20 million children born each year, but the vast majority of low-birth-weight cases – 96.5% – are in developing countries.

Children's development continues in the study (19659002) The sildenafil clinical trial is also being conducted in the United Kingdom, Canada, Australia, and New Zealand.

Dr. Katie Groom, associate professor of maternal and perinatal health at the University of Auckland and chief investigator of the Australian and New Zealand studies, said these lung problems and deaths were not seen there and in the UK, though they certainly all cases studied in the study be.

Dr. Ken Lim, a clinical professor at the Department of Obstetrics and Gynecology at the University of British Columbia, said in an e-mail that the trial was suspended in Canada. The trial started there in 2017 and consisted of patients in three locations until it was stopped following news of deaths in the Netherlands.

"We are not aware that the negative results among the 21 Canadian study participants have increased, we contacted the one Canadian woman who was in the study and told them to stop taking the drug or placebo Lim.

Groom said that the research teams at all sites "will continue to study our data in as much detail as possible within the consortium to train if This finding is real or coincidental. "

She noted that the drug is used to treat pulmonary hypertension, which is defined by the American Heart Association as high blood pressure in the cardiopulmonary system, making it at first sight unlikely sildenafil has caused this problem. However, it is biologically plausible that withdrawal of the drug at birth has resulted in a rebound effect on the pulmonary vessels, which means that discontinuing the drug at birth may have led to the complication.

Pammi said that it will be safe to ask questions about whether and how sildenafil could have been responsible for the deaths and lung problems in the Dutch study, the doses of mothers, the timing and any differences in women's medical care investigate the Netherlands in comparison to other countries

"Maybe they will do something different," he said.


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