The US Food and Drug Administration responded to a federal judge’s question about warning labels for acetaminophen OTCs by declining to comment on pending litigation while also submitting a recent review of available epidemiological evidence for the ingredient.
Court Wants Defense Of Acetaminophen Pregnancy Warning, US FDA Provides Research Review
Review makes clear FDA’s thinking on safety acetaminophen use during pregnancy, but likely won’t sway federal judge from her conclusion that a warning about risks of in utero exposure could be added to drug containing the ingredient and available under an OTC monograph without violating FDA regulations.
