MEDIA STATEMENT

STEVENS-JOHNSON SYNDROME

13th   January 2005

A recent case involving a 7-year-old girl who was reported to have been diagnosed with Stevens-Johnson Syndrome alleged to be associated with taking paediatric ibuprofen, has been reported to us.  

This syndrome is extremely rare and appears usually as a severe skin reaction.   Its precise cause is not known but association with a range of medications has been reported, as has the possible involvement of infections including viral conditions. However, the weight of medical evidence has shown that medicines known as NSAIDs are not implicated in the occurrence of this disease (1,2,3).

As with a number of OTC medicines, some ibuprofen products contain reference to the possibility of an allergic reaction with symptoms such as itching, swelling, wheezing etc.   The advice is to cease medication if this occurs and seek medical advice.

In normal use, ibuprofen has been shown to be one of the safest OTC medicines for the treatment of pain and fever, particularly in the symptoms of colds, headache, toothache etc.   Ibuprofen has been approved by regulatory authorities around the world for self medication in conditions such as these.

References:

1. Chan HL et al.   The incidence of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.   A population-based study with particular reference to reactions caused by drugs among outpatients. Archives of Dermatology, 1990; 126(1): 43-47.

2. Rainsford KD (Ed).   Ibuprofen: A critical bibliographic review.   Taylor and Francis, 1999, London: pp 504-506.

3. Roujeau JC et al.   Medication use and the risk of Stevens-Johnson syndrome of toxic epidermal necrolysis.   New England Journal of Medicine, 1995; 333(24): 1600-1607.

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