British Journal of Clinical Pharmacology
British Journal of Clinical Pharmacology
5 years ago

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

Marie-Josèphe Jean-Pastor, Claire Guy, Bénédicte Lebrun-Vignes, , Marie Zenut, Valérie Gras-Champel
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.

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1111/bcp.13445

You might also like
Discover & Discuss Important Research

Keeping up-to-date with research can feel impossible, with papers being published faster than you'll ever be able to read them. That's where Researcher comes in: we're simplifying discovery and making important discussions happen. With over 19,000 sources, including peer-reviewed journals, preprints, blogs, universities, podcasts and Live events across 10 research areas, you'll never miss what's important to you. It's like social media, but better. Oh, and we should mention - it's free.

  • Download from Google Play
  • Download from App Store
  • Download from AppInChina

Researcher displays publicly available abstracts and doesn’t host any full article content. If the content is open access, we will direct clicks from the abstracts to the publisher website and display the PDF copy on our platform. Clicks to view the full text will be directed to the publisher website, where only users with subscriptions or access through their institution are able to view the full article.