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Court Wants Defense Of Acetaminophen Pregnancy Warning, US FDA Provides Research Review

 
• By Malcolm Spicer

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.

• Source: Shutterstock

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.

Although the review likely will make clear the FDA’s current thinking on the safety for women using acetaminophen during pregnancy, the information just as likely won’t sway Judge Denise Cote in US District Court for Southern New York from a conclusion she previously stated, that a warning about the risks of in utero exposure could be

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