It's Official: No FDA approval for Arcoxia
As suspected, the FDA declined to approve the COX-2 drug etoricoxib (Arcoxia) – Merck's follow-up to the COX-2 Vioxx, which they pulled from the market in 2004. Arcoxia data was reviewed by the FDA's Arthritis Advisory Committee several weeks ago, but the committee voted 20 to 1 against recommending its approval. Although the FDA does not have to follow the recommendations of the advisory committee, it usually does.
Although the official "nay" to approval is not surprising, it leaves the one remaining COX-2 on the market – Celebrex – as the only option in that class of nonsteroidal anti-inflammatory drugs (NSAIDs). Some people with arthritis found the two defunct COX-2 drugs, Vioxx and Bextra, to work better for them than Celebrex, and were looking forward to a potential new option that might provide pain relief while sparing the gastrointestinal irritation and side effects of traditional NSAIDs. Others, both patients and doctors, have been concerned about the safety of not only the COX-2s, but all NSAIDs, since more has been learned about the risks in the past three years.
Is it better to have a pain relief option that may increase your risk of a cardiovascular side effect, if being more functional will help you be active enough to reduce your cardiovascular risks through exercise? And if you could exercise more, would you? Or would you rather not take the risk of affecting your heart? Why or why not?
I'm working on an article right now about this entire issue, which includes comments from you, readers who answered Arthritis Today's latest online poll, as well as doctors on both sides of the issue. Look for the finished version in the July-August issue. In the meantime, it's not too late to voice your opinion on the subject. Leave a comment to this post and share your thoughts. If you're OK with me including your comment in the published version of the article, just say so. (Be sure to include your name, city/State, age and arthritis condition; don't worry, I'll delete all that information before I post your comment.)
Donna Siegfried
posted by DRSiegfried @ 9:53 PM
5 comments
5 Comments:
This comment has been removed by a blog administrator.
Speaking as both a suffering victim of arthritis and as a medical professional (RN), I would like to offer my opinion. I would rather have less pain and increased function than to make no intervention and let the ravages of inactivity take me down. Not only does inactivity negativly effect the cardiovascular system but it also leads to bone and blood formation problems as well as depression. I will take my risks with the pain relief option.
I have RA and did get some relief from pain with Vioxx, nothing from Celebrex. Since I don't have any heart problems, I would like to have the option of taking the new Merch drug, under the supervision of my rheumatologist. ALL drugs have side effects and popping lots of Advil (which I was doing daily at one point) cashes your liver. I think we need the alternative.
Having both OA and Sjogrens Syndrome and using both Vioxx and later on Bextra at the lowest dose relief from the low dose of Bextra was no pain at all. Taking it off the market could have been a decision the Doctor and patient could have decided on for heart risk or any other problem. There have not been any new drugs for OA patients but many new drugs for RA that can cause many serious side effects. We need a new drug for OA to give long lasting relief.
To Donna Siegfried,
I always look forward to receiving the Arthritis Today magazine and I read it cover to cover. I have had psoriatic arthritis much of my life.
The recent July-August 2007 version mentioned your recent diagnosis and your recent pregnancy. It also had a section on page 84 about someone with RA who is trying to get pregnant.
I truly do not comprehend why a woman would choose to give birth or raise children when she knows she has arthritis, a lifelong chronic disabling disease. It baffles me, and I wonder WHY as well as HOW one plans to physically be available for a baby, then a toddler, and then a youngster, etc. Why and how?
Could you address this and/or refer me to a source if this situation is addressed elsewhere.
Thank you very much.
Sincerely,
Shelley
Post a Comment
<< Home