Acetaminophen (paracetamol) is an active ingredient used for pain relief and to reduce fever in prescription and over the counter preparations. The FDA issued their advice following a review of the FDA Adverse Event Reporting System (FAERS) database and the medical literature, which identified a rare but serious risk of skin reactions associated with acetaminophen use.
Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalised exanthematous pustulosis (AGEP), can be fatal, with symptoms such as reddening of the skin, rash, blisters, and detachment of the upper surface of the skin. The FDA communication notes that it is difficult to determine the frequency of these skin reactions accurately as acetaminophen is widely used, can be used long or short term and has been on the market for many years. However it is likely that these events (i.e., SJS, TEN, and AGEP) occur rarely.
The FDA communication advises:
• Anyone who develops a skin rash or reaction while using acetaminophen or any other pain reliever/fever reducer should stop the drug and seek medical attention right away.
• Anyone who has experienced a serious skin reaction with acetaminophen should not take the drug again
• Health care professionals should be aware of this rare risk and consider acetaminophen, along with other drugs already known to have such an association, when assessing patients with potentially drug-induced skin reactions.
The FDA has requested that a warning be added to the labels of prescription drug products containing acetaminophen to address the risk of serious skin reactions. The Agency will also request that warnings are added to new OTC drug products containing acetaminophen and will encourage manufacturers of existing OTC products to do the same.
The FDA has developed a Question and Answer document to support their safety communication.