2004N-0559 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee
FDA Comment Number : EC29
Submitter : Dr. Al Musella Date & Time: 02/07/2005 04:02:30
Organization : Musella Foundation For Brain Tumor Research
Health Care Association
Category :
Issue Areas/Comments
I think it is imperative that celecoxib remains available to the public. Aside from the use as a anti-inflammatory agent, it is also showing promising early results for many types of cancers including brain tumors. For example, see: http://virtualtrials.com/news3.cfm?item=2595
The possible risks that were recently revealed about this class of drug are exceedingly minor compared to the risks of the other treatments for these cancers, or the risk of the tumors growing.
My idea: have patients sign a consent form when celecoxib is dispensed, showing that they understand the stated risks and are willing to take these risk. This way, the drug is available to those who need it.