For patients with arthritis and the physicians who treat them, “it remains critical to consider factors that affect the risk/benefit ratio when determining whether to continue or discontinue any pharmaceutical product, including those NSAIDs (non-steroidal anti-inflammatory drugs) that are under scrutiny for potential increased health risks,” stated American College of Rheumatology president, Elizabeth Tindall, MD. “Treatment guidelines exist to help physicians choose the best treatment options for their patients based on current scientific studies.”

In September 2004 Merck voluntarily removed rofecoxib (Vioxx®) from the world market due to adverse cardiovascular and cerebrovascular events. Since then, multiple reports of other NSAIDs possibly causing these same adverse effects have been released to the press. Many patients and physicians are disconcerted by the conflicting preliminary data regarding potential risks from taking celecoxib (Celebrex®), valdecoxib (Bextra®) and most recently naproxen (Aleve®).

The newest data reported by Pfizer from the APC and PreSAP studies suggest the possibility of increased risk of serious cardiovascular events for patients taking Celebrex® at doses of 400 mg to 800 mg daily. Information reported in November 2004 suggested that Bextra® posed similar risks for cardiovascular events as that of Vioxx®. In another trial, Aleve®, a drug previously believed to have some preventive cardiovascular effects, also showed indications of elevating heart risks and strokes in a study designed to prevent Alzheimer's disease. In each case, the FDA is analyzing the data and has offered limited warnings. In the case of Aleve®, the FDA recommends that patients take it for no more than ten days and then contact their physicians for further recommendations. The FDA has asked Pfizer to voluntarily discontinue all direct-to-consumer advertising for Celebrex® and has required strengthened label warnings for Bextra®.

“It is unfortunate that physicians and patients have limited preliminary data, some of it in direct conflict with existing conclusions, causing anxiety that, at this time, cannot be definitively confirmed nor refuted,” stated Dr. Tindall. Because peer-reviewed data and analysis are not available to substantiate the studies' preliminary results, the validity of elevated health risk conclusions are unknown. To address these concerns, the American College of Rheumatology advises physicians to follow the current treatment guidelines and manufacturers' dosage recommendations.

Treatment guidelines developed by the American College of Rheumatology for rheumatoid arthritis 1 (RA) in 2002 and osteoarthritis 2 (OA) in 2000 include recommendations for patients at high risk for adverse gastrointestinal (GI) events. These guidelines are consistent with existing, documented peer-reviewed study data. Patients taking Celebrex®, Bextra® and Aleve® who have concerns about their risks for GI or cardiovascular complications should consider stopping the medication or substituting another pain medication when medically appropriate and in coordination with their physicians' advice. Definitive recommendations regarding the risk profile of medications that modify pain and inflammation will continue to evolve. Complete analysis of data from existing, current and future studies specifically designed to test cardiovascular effects of these agents will be incorporated in updated guidelines.

Pfizer Medicine Arthritis