Is acetaminophen associated with a risk of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis? Analysis of the French Pharmacovigilance database.

Summary

Aim

Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are rare but severe mostly drug-induced cutaneous reactions. Acetaminophen is an over the counter drug worldwide used to treat pain and reduce fever. In 2013, the FDA informed the public that acetaminophen was associated with a rare risk of SJS/TEN. The aim of this retrospective study is to analyse reports of acetaminophen as a possible suspect in the development of SJS/TEN from the French Pharmacovigilance Database (FPDB).

Methods

Cases of TEN/SJS with acetaminophen as a suspect drug registered in the FPDB collected from January 2002 to December 2013 were analysed by an expert group. The Algorithm of Drug causality for Epidermal Necrolysis (ALDEN) was used as a reference tool for SJS/TEN to assess the causality of each suspect drug.

Results

After exclusion of 16 non-validated cases, 112 cases (47 TEN, 51 SJS, 14 SJS/TEN overlaps) involving 574 suspected drugs (5⋅1/case) were analysed. In 80 cases, the acetaminophen ALDEN score was inferior or equal to other more suspected drugs. In 32 cases, acetaminophen had the highest score but matched with a "very unlikely" or "unlikely" causality in 12 cases. For the 20 remaining cases with a "possible" or "probable" causality, a protopathic or a confounding bias was likely in 14 cases.

Conclusions

After analysis of the French pharmacovigilance data using the ALDEN algorithm, we did not find an obvious SJS/TEN risk related to the use of acetaminophen in this large national series.

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