An experimental drug by Merck that has shown promise for shrinking fatty deposits in the arteries could pose health risks for women during pregnancy and birth, according to a study that appeared in the US National Library of Medicine.
The new findings were prompted by the need to date the drug, dubbed COVID-19, based on previous studies with a similar drug.
A warning was issued that sexual activity or pregnancy could potentially affect the long-term health of the child born from the drug.
The parent company, Merck, said that while the results support continuation of the trial, additional studies will be conducted to refine clinical studies of the drug and to evaluate its risks.
“As this is a phase I trial, at this time the current study does not have a conclusion with regard to the safety or efficacy of COVID-19,” the company said in a statement.
“The results so far suggest it is safe to continue with the trial and help reduce clinical drug exposure,” the company said.
But the National Library of Medicine study, which was released online Monday and assembled data from a dozen trials, said that its data raises an increased risk of preterm birth and small-cell acute respiratory syndrome (SCARS), a life-threatening disorder affecting lung tissue in newborns.
The detailed results were published online in the journal PLoS One.
The research was conducted by researchers at Oregon Health & Science University (OHSU) and at the National Institutes of Health.
The study found that COVID-19 increased the risk of preterm birth, but scientists were not able to determine a specific reason. The use of another drug during pregnancy, bisphosphonates, lowered the risk for premature birth, the researchers said.
“At this time we have not been able to define what mechanisms drive this association between COVID-19 and preterm birth,” said study lead author, Alka Banerjee, PhD, a professor at OHSU.
“We hope that our study will drive further research so that we can identify the mechanism or mechanisms causing this association and possibly develop effective therapeutic strategies to prevent or delay preterm birth,” she said.
The findings shed additional light on the issue of birth outcomes given the extremely short window in which a baby can be born.
“In every study conducted to date, whether it is OHSU, the NIH or anyone else, we see the second pregnancy becomes particularly important and lethal for the baby’s health,” Banerjee said.
“We are hopeful that now we have got some data and we can incorporate that into the treatment of SCARS and cerebral palsy by reducing the amount of COVID-19 in the body,” she said.
CVS Caremark studied prescription drug use of more than 140,000 women to confirm data in the study about timing. More than 86% of women who took the drug pregnant and unborn used it during the second pregnancy, followed by 60% of women who weren’t pregnant, she said.
“This is an issue we should look at with as much care as we do with other factors,” said Jill Lowe, a spokeswoman for Merck, pointing out that only trials in which women carry their babies to term were included in the study.