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US Revamped OTC Monograph Program Changes Start With Acetaminophen Skin Reaction Warning

 
• By Malcolm Spicer

Proposed change is “the first FDA-initiated proposed order that was not statutorily required” by the 2020 legislation authorizing the agency’s overhaul of the program which makes the large majority of nonprescription drugs available in the US.

• Source: Shutterstock

The first OTC monograph change the Food and Drug Administration proposes using its overhauled program, outside of finalizing 32 monographs as required in the 2020 legislation authorizing the overhaul, will require warnings about skin reactions for acetaminophen-containing oral drugs.

Although the agency broached the subject more than a decade ago by informing consumers that acetaminophen use is associated with a risk of rare but serious skin reactions, its 14...

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