Celebrex and Children
Editor’s Note: This article was originally written by patient expert Cathee McKeown.
What would you do if you were a parent with a child suffering from Juvenile Rheumatoid Arthritis? Unfortunately there are limited options for treatment of children with this disease. Despite Celebrex’s well-documented link to higher heart risks, Pfizer Inc. wants permission to sell its painkiller to treat children as young as 2 who have arthritis.
A recent vote from the FDA Arthritis Advisory Committee recommended that Pfizer Inc. be allowed to market the painkiller Celebrex as a treatment for children with JRA. In a 15-1 vote, the advisers said the benefits of the drug outweighed its risks for juvenile rheumatoid arthritis patients 2 yrs and older. The feeling was that short-term efficacy looked good and short-term safety was not an issue. Long-term safety is totally unknown" and needs to be known.
The panel recommended that the FDA require Pfizer to study the long-term safety of the drug, possibly by creating a registry of patients that would allow their health to be tracked for 10-20 years. Pfizer said the results of a six-month study showed that Celebrex works just as well as Naproxen (the most common treatment for JRA) in treating young patients with rheumatoid arthritis. The concern over cardiovascular risks in long-term use has been studied in adults, but no long term studies have been done in children.
Basically, by allowing children to be put on Celebrex, they become the study. As with all new medications, someone has to be the "guinea pig" if you will. Is that a chance you are willing to take? Since I do not have children of my own, I can only imagine how difficult these decisions are. Some doctors who treat children with RA already prescribe Celebrex because other painkillers upset their stomachs. This is considered "off-label" use and is allowed when deemed appropriate by individual doctors. Up until now this treatment could not be promoted by drug makers. With the new FDA recommendations, it can be promoted by Pfzier if they can show the safety and efficiency has been formally tested in children.
So where does that leave parents who want to treat their children for the pain and suffering they have today but do not know enough about the drug in the long term? It’s a question I have asked myself every time my doctor recommends a new medication for me to try because I have failed all of the others. Since we are living in a time where constant research has allowed us to develop so many different options in treating RA, we are also left with many questions.
For myself, I look at it like this" I have had RA for 10 years. I have literally tried dozens of traditional medications, alternative therapies, and I still suffer on a daily basis. If there is just one medication or treatment that will work for me, then I am willing to give it a go. I have the luxury of making these decisions for myself and ultimately it is my choice. When dealing with children it is a whole other issue. But I would encourage all parents or caregivers of children with Rheumatoid Arthritis to do the research. Ask questions, talk to your doctors, talk to other parents who have children with RA.
Unfortunately, there are no guarantees in life. What we do today will affect what happens tomorrow. If we choose not to participate and take chances, then things will never change. I remember when Enbrel first came out and I was the very first patient my rheumatologist prescribed it for. We were both nervous. We really had no expectations but hoped for the best. It didn’t work for me but it worked for many of his other patients and that alone was worth it.
That is what having a chronic disease is all about trial and error. Some things will work and others will not. The most important thing is that we try. I’m sure that Celebrex will help many adults and hopefully children alike. There are risks and there are doubts" but what else do we have? At some point you have to trust your instincts and make the hard choices. I hope that every parent and child who deals with JRA have the support and the strength to make the hard choices and eventually find what is right for them.
I too am making the hard choices and I know that my resolution to fight this disease is out there ahead of me. I’m going to keep on trying by educating myself, asking the important questions and listening to my inner voice. I hope you will too.
What are your thoughts on the FDA Arthritis Advisory Committee voting to approve Celebrex for use in children? Share your view on the RA Message Boards.