2004N-0559 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee
FDA Comment Number : EC66
Submitter : Dr. Mark Pinkerton Date & Time: 02/07/2005 06:02:04
Organization : Monte Vista Family Practice, PC
Health Professional
Category :
Issue Areas/Comments
Dear FDA,
I am a Family Practictioner writing in support of the Cox-2 inhibitors, Celebrex and Bextra. First, let me say that I did see problems with Vioxx of hypertension and leg edema. I have not seen these problems with Celebrex or Bextra and early in the marketing of these drugs, they became the ones I preferred for the above reason.

The best example that I can find in support of Celebrex is with my wife. In the winter of 1997, at the age of 37, she developed a severe case of arthritis that she is still fighting. The only other NSAID that she has been able to take before the Cox-2 inhibitors was Daypro. Even then, she had spells of episodic abdominal pain and the drug did not control her arthritic symptoms. After a visit to the rheumatologist, she was placed on Plaquenil and Prednisone in addition to the Daypro. The Prednisone was weaned off, but she would need episodic burst to control her symptoms. She had increased nightmares on the Plaquenil. Her arthritis is a nonspecific type. A disease altering medication was not mandatory, so when Celebrex hit the market in 1999 the decision was made to give it a try. Since then, she is off the Plaquenil, has only had to have one burst of Prednisone and only one episode that was short lived of abdominal pain in the six years! She is taking Celebrex 200mg bid. Since she started, she is back to high country activities that we enjoy here in Colorado. More importantly, she is back to her full schedule of daily activities. Last year, she started teaching preschool which has the demands of preschoolers literally pulling her in two directions by her fingers as they compete for her attention.

When the controversy of the Cox-2 inhibitors came out last fall, my wife made it very clear to me that she is taking the risk of a heart attack instead of returning to live in the land of arthritis and not functioning with it. The thought of Plaquenil and the side effects of blindness or reduced vision is not one she wants to consider again. Please, DO NOT allow Celebrex to be pulled from the market. I agree that I would rather have her live life well, more than live life long.

I have other success stories in my practice of Celebrex. There was an 89 year-old man in the assisted living that had several major GI bleeds on other NSAIDS. Since they were stopped, the patient and family begged of me to let him try Celebrex as he was wheel chair bound. Since Celebrex was started in 1999, he stopped his Percocet and is back to walking. He is still alive.

Just yesterday, an 88 year old woman asked in a worried state if she had to stop her Bextra as it has been the only thing that helped.

Personally, I believe that the Cox-2 inhibitors are the first to be caught as they are the only ones to be studied. When I was in residency in 1992, I saw a lady in the ER that had a shoulder/neck strain. She was placed on Naprosyn and saw her primary care physician that believed the same. Five days later, she was dead on arrival with a massive MI. I did an extensive literature search at that time on Naprosyn/NSIAD and MI's and not one single article was found! My question is have the other NSAID from years gone by been adequately studied?

I see a trend in society of the public demanding instant results with no side effects that are easy to take. This issue is an excellent time to educate the public that meds do have side effects, but they can help more debilitaing problems in the meantime. This is demonstrated to me regularly by the number of patients I see stopping there medication after they see a TV ad and stop for example Lipitor as it might damage there liver even though there are multiple nomral liver test in the chart.

Mark Pinkerton, MD
Monte Vista Family Practice, PC
103 Chico Court
Monte Vista, Colorado 81144

CO Lis #33488