Published: 6 June 2014

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Paracetamol and Serious Skin Reactions

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Prescriber Update 35(2)
6 June 2014

 

Paracetamol is widely used to reduce pain and fever and can be purchased over-the-counter in addition to being prescribed. Paracetamol is available as a single-ingredient product and in combination products, including cough and cold preparations.

The U.S. Food and Drug Administration (FDA) recently issued a drug safety communication warning that paracetamol can, in rare cases, cause serious skin reactions, also known as Severe Cutaneous Adverse Reactions (SCARs)¹.

SCARs include Stevens Johnson Syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis, and erythema multiforme. These reactions can occur when using paracetamol for the first time or at any time during administration, and can be fatal. It is likely that these reactions occur rarely.

The Centre for Adverse Reactions Monitoring (CARM) has received four reports of serious skin reactions causally associated with paracetamol. These included two reports of erythema multiforme, one of toxic epidermal necrolysis and one of Stevens Johnson Syndrome.

Patients should be advised to consult their doctor at the first appearance of a skin rash, skin peeling, mouth ulcers, or any sign of hypersensitivity. If serious skin reactions occur, discontinue paracetamol immediately.

Non-steroidal anti-inflammatory drugs (NSAIDs) also used to treat fever and pain/body aches, can also cause SCARs². However, there does not appear to be cross-sensitivity between paracetamol and other medicines that reduce pain and fever¹.

References

1. Food and Drug Administration, 2013. FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen. FDA Drug Safety Communication 1 August 2013. URL:  www.fda.gov/drugs/drugsafety/ucm363041.htm (accessed 24 April 2014).
2. Medsafe. 2012. NSAIDs can SCAR (Severe Cutaneous Adverse Reaction). Prescriber Update 33(2): 11-12. URL: www.medsafe.govt.nz/profs/PUArticles/NSAIDScanSCARJune2012.htm (accessed 24 April 2014).