A pill developed by pharmaceutical company Merck has been deemed an effective treatment against COVID-19 by the Food and Drug Administration, but further guidance is being sought regarding risks it might pose for pregnant COVID patients.
Molnupiravir has proven highly effective in cutting down hospitalization rates in patients experiencing mild-to-moderate bouts of COVID.
However, during their review, the FDA identified a number of possible risks.
Tests of the pill on animals showed a chance of toxicity to developing fetuses as well as the possibility of birth defects.
The regulatory body has scheduled a public meeting to seek opinions from outside experts, academic and otherwise, regarding the safety of the pill, marking the first public review of any COVID treatment.
Though the FDA won’t be bound to their recommendations, it could require the drug carry a warning about its risk to pregnant women if deemed necessary.
Despite a possible warning though, doctors would still be allowed to prescribe the pill to COVID-positive pregnant women in certain situations if the risks are outweighed by the benefits.
Merck has already agreed that, given the questions about safety, the pill will not be used on COVID-positive children, according to the FDA.
Additional side effects were determined to be both rare and mild, the most common being diarrhea in about 2% of patients.
“While the clinical safety data base was small, there were no major safety concerns identified,” FDA reviewers said.
Molnupiravir treats COVID by preventing the virus from reproducing, which it accomplishes by inserting minor mutations to the virus’s genetic code.
There is a concern that the treatment could result in new COVID variants.
If authorized, it would be the first at-home treatment for COVID-19. Currently all drugs allowed by law must be given via injection or IV and must be administered by health professionals.
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