2004N-0559 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee
FDA Comment Number : EC75
Submitter : Dr. James Campbell Date & Time: 02/07/2005 07:02:50
Organization : Johns Hopkins
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
Thank you to the FDA Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee for soliciting comments on perspectives about relative risk and benefits of COX-2 and other nonsteroidal antiflammatory medicines used to treat pain. Patients with pain are confronted with challenging choices to control pain, chronic pain in particular. Concerns exist with regard to efficacy, side effects, and morbidity with all drugs. Pain is a very important health care problem. Untreated pain poses its own set of morbidities. Patients have available to them opioids and NSAIDs as the two most important drug classes. Many, many patients do not tolerate NSAIDs (to say nothing about the renal, gastric risk issues) because of side effect symptoms. Aspirin in many ways is a dangerous drug. The American Pain Foundation supports having an educated patient and educated doctor make informed choices about what is best in a given situation. All drugs have risks and it should be left to the doctor and patient in this instance to make a final choice about what treatment is best for them individually. The government should advise but should have a limited role in denying access to this important class of medications.