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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
Abstract:
Rofecoxib is a nonsteroidal anti-inflammatory drug that is reported to act by selectively inhibiting cyclooxygenase-2. A review and analysis of reports sent to the Spontaneous Reporting System of the Food and Drug Administration, Rockville, Md, suggest that aseptic meningitis is associated with rofecoxib use. To our knowledge, there have been no published reports of aseptic meningitis occurring in association with rofecoxib use to date. We report 5 serious cases of aseptic meningitis associated with rofecoxib use.
Insights
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.