2004N-0559 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee
FDA Comment Number : EC82
Submitter : Dr. Karen Kaiser Date & Time: 02/07/2005 07:02:05
Organization : Maryland Pain Initiative
Individual Consumer
Category :
Issue Areas/Comments
As an arthritis sufferer who has taken a Cox 2 inhibitor every day for the last 4 years to help manage my pain and discomfort, I cannot imagine life without this class of medications. I take my Cox-2 inhibitor along with several other medications to help manage my disease and my pain. I have a platelet disorder that makes me prone to bleeding, making it risky for me to take non-specific Cox inhibitors (NSAIDs) such as ibuprofen and naproxen. Although initially on Vioxx, since it has been taken off the market, I have switched to Bextra, and neither that medication or choline magnesium trisalicylate, which I used prior to the Vioxx, relieve my suffering as much as Vioxx.

The switch off Vioxx has required me to use steroids intermittently over the last year to control my pain and maintain function. Steroids has numerous side effects, including bleeding and death, which prevents it from being a long term management strategy for my arthritis. Unfortunately I have first hand experience with a brother-in-law who died of complications from taking steroids for his rhuematoid illness.

In addition to being an arthritis suffer, I am a nurse, a pain researcher, a pain specialist, and am involved in numerous pain organizations - the American Pain Society, the Maryland Pain Initiative, the American Society of Pain Management Nurses, and the Oncology Nursing Society. Everyday I see patients for whom non-specific Cox inhibitors and steroids cannot safely be used. I implore you to provide those of us in need of pain relief the medications we need. Cox-2 inhibitors can provide safer alternatives to other medications with potentially worse complications. I stongly believe that the decision to use Cox-2 inhibitors should be left to patients in conjunction with their health care practitioners. Removal of Cox-2 inhibitors will cause me, and many others undue pain and suffering.