FDA: Acetaminophen associated with a risk of rare but serious skin reactions

FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen

 On August 1, 2013, the FDA issued a Drug Safety Communication informing the public that acetaminophen has been associated with a risk of rare but serious skin reactions. These skin reactions can be fatal.

• Stevens- Johnson Syndrome (SJS)
• toxic epidermal necrolysis (TEN)
• acute generalized exanthematous pustulosis (AGEP)

Reddening of the skin, rash, blisters, and detachment of the upper surface of the skin can occur with the use of drug products that contain acetaminophen.

These reactions can occur with first dose or even at any time during treatment. Take care about any other drugs used to treat fever and pain/body aches (e.g., non-steroidal anti-inflammatory drugs, also known as NSAIDS, such as ibuprofen and naproxen) also may cause serious skin reactions, which is already described in the warnings section of their drug labels.

If any one has any serious skin reactions must stop the drug immediately and seek medical attention and not return to the drug again. 

This new information resulted from the Agency’s review of the FDA Adverse Event Reporting System  database and the medical literature to evaluate cases of serious skin reactions associated with acetaminophen. 

FDA will require that a warning be added to the labels of prescription drug products containing acetaminophen to address the risk of serious skin reactions.  FDA will also request that manufacturers add a warning about serious skin reactions to the product labels of OTC acetaminophen drug products marketed under a new drug application and will encourage manufacturers of drug products marketed under the OTC monograph do the same.