Kenvue Confident Of Convincing Federal Court Of Safety Of Acetaminophen Use During Pregnancy
Plaintiff in complaint filed in US District Court for Southern New York alleges FDA-required pregnancy label warning for acetaminophen available under OTC monograph isn’t adequate and causes a failure to warn about potential risks.
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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.
In Drug Safety Communication, FDA says it is requiring labeling changes for Rx as well as OTC NSAIDs due to risk of rare but serious kidney problems in an unborn baby.
Final US guidance adds CHPA's suggestion for an example for a warning on labeling for products containing both acetaminophen and aspirin, needed to highlight where “Allergy Alert” and “Liver Warning” statements are on those products' labels.