| 2004N-0559 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee|
|FDA Comment Number :||EC57|
|Submitter :||Ms. Rosemary Graham||Date & Time:||02/07/2005 06:02:44|
|Organization :||Lupus Foundation of America, Inc. , GA Chapter|
| I am a person diagnosed with lupus, myositis, pulmonary fibrosis, fibromyalgia, mitral valve prolapse, and acid reflux. I was taking Vioxx for pain (prn as needed with low dosage) when it was pulled from the market. I cannot take Baxtra or Celebrex. I was taking Aleve, but now taking Liquid Advil and 8-hour Tylenol. I have several allergies, including most antibiotics and sulfa.
Patients like me need OPEN access to medications, and that should be determined and monitored by our personal physicians and specialists. Committees and groups that restrict or remove access to medications widen mistrust in the medical profession, tampers with the doctor/patient relationship, limits "quality of life" issues through usage of ineffective medications, and increases healthcare cost through increased emergency medical visits.
Surely safety and risk management factors should be considered with all drugs, (i.e., Cox-2 inhibitors), however, ACCESS to medications that may improve "quality of life" should remain open.