Docket Management
Docket: 00N-1269 - Labeling for Human Prescription Drug/Biologic Products
Comment Number: EC -17

Accepted - Volume 4

Comment Record
Commentor Mr. ROBERT MARTIN, MS, CFNP Date/Time 2001-05-11 23:34:10
Organization ADVANTAGE FAMILY HEALTHCARE, PLLC
Category Health Professional

Comments for FDA General
Questions
1. General Comments I would like to make comment that I am whole heartedly against the FDA's package labeling of Celecoxib (Celebrex), Maxide, Ziac, HCTZ, and Lasix in regard to the drugs potential for allergenicity in patients allergic to sulfonamide antibiotics. Quite frankly, I would be interested in seeing the scientific data that the FDA utilized in making this decision. The science of the mechanism of allergenicity of sulfonamide antibiotics decries any possibility for cross-reactivity between celecoxib, HCTZ, Furosemide, or any other nonaromatic amine sulfonamide (NA sulfonamide) containing compounds in patients known to be allergic to arommatic amine sulfonamides (AA sulfonamides). Did the FDA even consider the biochemistry involved in the mechanism of this immunologic reaction? Or did the FDA simply view the ill-defined term sulfonamide, and decide to blanket a vast segment of the population denying them the benefits of these medications without applying good science? Ladies and Gentleman, it is the 21st century; the science is there for heavenís sake. Use it. This is not the middle ages. The fact that you might have drawn conclusions from such superficial and subjective observations, is dumbfounding. We use empirical evidence, objective data, and the scientific method to come to critical conclusions. Please, do so here. By taking this stance, your agency has opened the door for frivolous and misplaced law suits against healthcare providers, denied millions of patients medications that can improve their quality of life and health, and have short-changed both yourselves and the American people. It is my opinion that this misplaced contraindication places an unnecessary burden on both the physician and the millions of patients who should be allowed to benefit from these medications, and feel confident that they are safe in doing so. Ladies and gentleman, science supports this conclusion, I hope you will as well. Thank you. Best Regards, Robert Martin, MS, CFNP




EC -17