Hypersensitivity reactions associated with exposure to naproxen and ibuprofen: A cohort study

The aim of the study was to evaluate the risks of hospitalisation and death due to hypersensitivity reactions associated with the NSAIDs naproxen and ibuprofen, using a record-linkage database for Tayside, Scotland (population 400,000). Cohorts of patients exposed to naproxen (n=54,038) and ibuprofe...

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Bibliographic Details
Published in:	Journal of clinical epidemiology 2001-12, Vol.54 (12), p.1271-1274
Main Authors:	McMahon, Alex D, Evans, Josie M.M, MacDonald, Thomas M
Format:	Article
Language:	eng
Subjects:	Anti-Inflammatory Agents, Non-Steroidal - adverse effects Biological and medical sciences Cohort Studies Cohort study Drug Hypersensitivity - epidemiology Drug toxicity and drugs side effects treatment Hospitalization - statistics & numerical data Humans Hypersensitivity Ibuprofen Ibuprofen - adverse effects Medical Record Linkage Medical sciences Miscellaneous (drug allergy, mutagens, teratogens...) Multivariate Analysis Naproxen Naproxen - adverse effects Nonsteroidal anti-inflammatory drugs (NSAIDs) Pharmacology. Drug treatments Scotland - epidemiology
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Summary:	The aim of the study was to evaluate the risks of hospitalisation and death due to hypersensitivity reactions associated with the NSAIDs naproxen and ibuprofen, using a record-linkage database for Tayside, Scotland (population 400,000). Cohorts of patients exposed to naproxen (n=54,038) and ibuprofen (n=79,513) were assembled. There were no deaths due to hypersensitivity. There was an increased risk of unvalidated hypersensitivity reactions during periods on-drug versus off-drug in patients exposed to naproxen and ibuprofen. However, after checking medical records, none of the three valid cases of hypersensitivity in the naproxen cohort and neither of the two in the ibuprofen cohort were judged to be due to NSAID exposure. A ‘worst-case’ scenario gave an adjusted rate-ratio of on-drug with naproxen versus on-drug with ibuprofen of 1.63 (0.50, 5.29). The study shows that hypersensitivity reactions associated with NSAID use are rare, and provides no evidence that the risks of hypersensitivity reactions differ between naproxen and ibuprofen.
ISSN:	0895-4356 1878-5921