Does The New COVID Pill Approved By FDA Carry Risks For Pregnant Women?

Merck’s COVID-19 antiviral pill was the first of its kind to receive regulators’ approval, but there is concern that it may carry risks for pregnant women. The reason? An ingredient called molnupiravir.

On Nov. 30, the Food and Drug Administration’s (FDA) advisory panel approved Merck’s application for an emergency use authorization for an antiviral pill to treat patients with COVID-19. This vote, however, was narrowly decided over concerns from some panel members about molnupiravir and its potential to cause mutations in human DNA, particularly for unborn fetuses.

At a public meeting of the FDA panel, Dr. James Hildreth, the president of Meharry Medical College in Tennessee, voted to oppose granting the authorization over concerns about the risks posed by the drug to a fetus.

“Do we want to reduce the risk for the mother by 30% while exposing the embryo and the fetus to a much higher risk of harm by this drug?” said Hildreth. “My answer is no, and there is no circumstance in which I would advise a pregnant woman to take this drug.”

Molnupiravir is a drug that creates compounds that closely resemble one of the building blocks of RNA, the genetic material found in COVID-19. It is designed to prevent the virus from replicating itself in the human body. Where this becomes potentially problematic is when the drug transforms into one that resembles building blocks for DNA, which can produce errors in the DNA of the patient or a fetus.

How this becomes a potential problem for a fetus has to do with the constant division of cells in a developing fetus. If human DNA is mutated before the fetus is conceived and transferred to it during the fertilization process, this can raise the risk of potential mutations in the child after it is born.

Previous studies showed that molnupiravir has the power to create mutations in DNA. The authors of one University of North Carolina (UNC) study warned that it could “contribute to the development of cancer, or cause birth defects either in a developing fetus or through incorporation into sperm precursor cells.” Animals were involved in the UNC study, but a researcher involved warned that human adults were still capable of seeing the same effects.

Merck disputed the findings of the UNC study, arguing that the animal subjects were exposed to molnupiravir for a longer period of time than COVID patients would be.

“We see this molecule as having a very low risk for mutagenicity,” Dr. Roy Baynes, Merck’s chief medical officer, told The New York Times. “This drug is used for five days, and the goal is to eradicate the virus quickly, and this is not a long-term treatment.”

Merck has not made public the results of its study, but the Associated Press previously reported that pregnant women were excluded during the trials. Researchers have called on Merck to share the results of their studies to see how they conducted tests.