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Clinical Observation
March 25, 2002

Aseptic Meningitis Associated With Rofecoxib

Author Affiliations

From the Office of Postmarketing Drug Risk Assessment (Drs Bonnel, Karwoski, and Beitz) and the Division of Anti-Inflammatory, Analgesic, and Ophthalmic Drug Products (Dr Villalba), Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Md.

Arch Intern Med. 2002;162(6):713-715. doi:10.1001/archinte.162.6.713

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.

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