Acetaminophen Receives a Labeling Change — Is Anything Safe?

This widely used drug is associated with severe skin reactions, but how often?

Acetaminophen is a commonly used, over-the-counter pain reliever and antipyretic agent. Billions of people worldwide take this medication annually. On August 1, 2013, the Food and Drug Administration elected to issue a warning to physicians and require a labeling change to warn consumers of the risk for serious skin reactions related to acetaminophen.

Comment

I was not able to find more than a handful of reports on PubMed of acetaminophen-related Stevens-Johnson Syndrome, toxic epidermal necrolysis, or acute generalized exanthematous pustulosis. Many of those I did find lacked evidence by my analysis of a strong cause-and-effect relationship between the drug and the skin reaction. Bottom line: Such a reaction is most likely extraordinarily rare, but clinicians caring for patients with severe adverse drug reactions should include acetaminophen in the list of drugs that might be responsible for such eruptions.

Reviewing Author

Jeffrey P. Callen, MD

Disclosures

Consultant / Advisory board XOMA; Eli Lilly; Celgene

Equity Various trust accounts

Editorial boards JAMA Dermatology; UpToDate

Leadership positions in professional societies Association of Professors of Dermatology (President-Elect)