Objective: Parecoxib, an injectable COX-2–selective inhibitor, is approved in over 80 countries for the short-term management of post-operative pain and, in some countries, for the treatment of acute pain or renal colic. Parecoxib first received regulatory approval in 2001 and there is a wealth of post-authorization data available regarding its use in real-world settings. The current study reviews this data to examine the occurrence of pre-defined safety events associated with COX-2 inhibitors and/or traditional NSAIDs. Methods: Data were derived from a Pfizer database which captures and stores reported adverse event (AEs) information from across the globe. AEs were coded to a specific Medical Dictionary for Regulatory Activities (MedDRA) term upon entry into the database. The database was searched for specific MedDRA terms or standard queries corresponding to the pre-defined safety events. The number of medically-confirmed cases, along with outcome, through March 31st 2014 was presented for each event. Results: The occurrence of pre-defined safety events was relatively low considering that 69,567,300 units of parecoxib were sold from the first quarter of 2002 through the first quarter of 2014. The total number of reports/number of reports classified as serious for each event over this period was as follows: cardiovascular embolic and thrombotic events (66/64), renal failure and impairment (77/68), gastrointestinal ulceration-related events (35/35), hypersensitivity reactions (190/98) including severe hypotension (32/25) and severe cutaneous adverse events (17/17), and masking signs of inflammation (18/18). Among reports with known outcomes, a majority of patients recovered or were recovering from these events. A total of 46 fatalities, which cannot be confirmed as treatment-related, were reported as outcomes: cardiovascular embolic and thrombotic events (20), renal failure and impairment (6), gastrointestinal ulceration-related events (4), hypersensitivity reactions (7) including severe hypotension (3) and severe cutaneous adverse events (2), and masking signs of inflammation (4). Conclusion: The occurrence of pre-defined safety events was relatively low with parecoxib considering nearly 70 million units were sold over a 12 year evaluation period, which is consistent with data from the clinical trial program. When administered according to the approved label, the overall benefit/risk assessment is considered favorable for parecoxib. Sponsored by Pfizer.

The safety profile of parecoxib for the treatment of post-operative pain: an examination of over 10 years of post-authorization safety data