US FDA warns of potentially fatal skin reactions to acetaminophen

2 August 2013

The US Food and Drug Administration has issued a safety warning over pain relief ingredient acetaminophen because of a risk of serious skin reactions.

The FDA said acetaminophen has been associated with a risk of rare but serious skin reactions. It is used to treat pain and reduce fever in many prescription and over-the-counter products. These skin reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal. These reactions can occur with first-time use of acetaminophen or at any time while it is being taken.

Other drugs used to treat fever and pain/body aches also carry the risk of causing serious skin reactions, which is already described in the warnings section of their drug labels.

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