| 2004N-0559 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee|
|FDA Comment Number :||EC47|
|Submitter :||Dr. Scott Reuben||Date & Time:||02/07/2005 05:02:00|
|Organization :||Tufts University School of Medicine|
I am writing this letter in support of the analgesic use of cyclooxygenase (COX)-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) for perioperative pain. Although most of the negative media press has emphasized the possible deleterious effects of COX-2 NSAIDs on cardiovascular morbidity and mortality the advantage of utilizing these COX-2 NSAIDs for perioperative pain management has mostly been ignored. Prior to the introduction of COX-2 NSAIDs the majority of our patients undergoing total joint arthroplasty were in severe pain prior to surgery since standard NSAIDs were discontinued prior to surgery because of the significant risk of perioperative bleeding (over two-fold). We have recently published the advantage of utilizing perioperative coxib administration for enhanced analgesia without the added risk of perioperative bleeding (J Arthroplasty 2002;17(1):26-31). We have shown the perioperative administration of coxibs offers significant analgesic benefit to these patients undergoing total joint arthroplasty. Further, the use of perioperative coxib administration for this surgical procedure was recently shown to improve postoperative outcomes (JAMA 2003;290:2411-8). In addition, we have recently shown the short-term administration of coxibs to patients undergoing spine surgery can not only reduce acute pain (JBJS 2005 in press) but also reduce the incidence of chronic pain following surgery. This has a significant economic impact since it has been shown that the early detection and treatment of a 30-year old patient who would otherwise progress to develop a persistent chronic pain syndrome might amount up to $1 million during the rest of that individual?s life (Reg Anesth Pain Med 2000;25:6-21). We believe the short-term administration of coxibs results in no significant increased cardiac risk to our patients. We have just completed a recent review of the medical charts (over 1,500 cases) in patients receiving coxibs for total joint arthroplasty in which there were no increased cardiovascular risks compared to no NSAID administration (unpublished data). We have also demonstrated the benefit of utilizing coxibs for perioperative pain management following a variety of abdominal, orthopedic, podiatric, dental, and ear nose and throat (ENT) surgeries (Anesthesiology 2003;99:1198-1208). I believe many of these surgical procedures are at significant risk for increased perioperative bleeding with the use of standard NSAIDs. In contrast, we have found no deleterious gastrointestinal, hematological, or cardiovascular morbidity with the short- term administration of COX-2 NSAIDs.
In summary, I believe the COX-2 inhibitors represent a significant therapeutic advance in the perioperative management of pain. Withdrawing the use of this class of NSAIDs will represent a significant step backwards in the management of pain.
Scott S. Reuben, MD
Director, Acute Pain Service
Professor of Anesthesiology and Pain Medicine
Baystate Medical Center and the
Tufts University School of Medicine