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Aseptic meningitis associated with rofecoxib
Renan A Bonnel1, Maria L Villalba, Claudia B Karwoski
1Office of Postmarketing Drug Risk Assessment, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Ln, Room 15B-23, HFD-430, Rockville, MD 20857, USA. bonnelr@cder.fda.gov
Archives of Internal Medicine
|March 26, 2002
Summary
Aseptic meningitis has been linked to rofecoxib, a nonsteroidal anti-inflammatory drug. This report details five serious cases, highlighting a potential adverse drug reaction not previously published.
Area of Science:
- Pharmacology
- Neurology
- Drug Safety
Background:
- Rofecoxib is a selective cyclooxygenase-2 inhibitor, a type of nonsteroidal anti-inflammatory drug (NSAID).
- NSAIDs are widely used for pain and inflammation management.
- Selective COX-2 inhibitors were developed to reduce gastrointestinal side effects associated with traditional NSAIDs.
Observation:
- Analysis of Food and Drug Administration Spontaneous Reporting System data suggested a potential association between rofecoxib and aseptic meningitis.
- No prior published case reports linked rofecoxib use to aseptic meningitis.
- Five serious cases of aseptic meningitis were identified in patients using rofecoxib.
Findings:
- The findings indicate a potential association between rofecoxib and the development of aseptic meningitis.
- This adverse drug event may be underreported in the medical literature.
- The observed cases suggest a possible neurological side effect of selective COX-2 inhibition.
Implications:
- Clinicians should be aware of the potential risk of aseptic meningitis in patients prescribed rofecoxib.
- Further investigation into the mechanism linking rofecoxib to aseptic meningitis is warranted.
- This highlights the importance of post-marketing surveillance for identifying rare adverse drug reactions.