12/15/09 [Updated 2/5/10] A federal agency has updated warnings about the risk of liver toxicity for all products containing diclofenac, including a new recommendation that liver function be evaluated four to six weeks after starting treatment.
Diclofenac is a nonsteroidal anti-inflammatory pain reliever that may be applied to the skin or swallowed. It is sold under the brand names Voltaren, Cataflam and Flector. Diclofenac is also combined with misoprostal in the medication Arthrotec.
According to a spokeswoman for the Food and Drug Administration, the cautions, which resulted from an internal review, apply to both the pills and topical products, though the agency says it has only received reports of liver damage related to the pill forms of the drug through its Adverse Event Reporting System (AERS).
As of March 18, 2005, the AERS database contained 146 U.S. cases of serious hepatotoxicity (liver toxicity) associated with diclofenac, including 32 cases of liver failure, which have resulted in transplants and deaths.
In a letter to doctors, Novartis Consumer Health and Endo Pharmaceuticals Inc., the companies that make and market a topical version, Voltaren Gel, wrote that its postmarket surveillance found borderline or greater elevations in liver injury tests occurred in 15 percent of diclofenac-treated patients, sometimes as early as the first month of use.
The company also advised that the best way minimize the potential risk for an adverse liver related event in patients treated with diclofenac sodium, is to use the lowest effective dose for the shortest duration possible.
Robert Shaw, MD, a rheumatologist at the Carroll County Arthritis and Osteoporosis Center in Westminster, Md., says physicians have long known to watch for liver damage in people who take diclofenac sodium pills, but that the new warnings make it clear that the gel also carries a risk.
“It’s especially a risk when patients come in and they’re on other medications that affect the liver or kidneys like statins. You’ve got to be aware that the gel can add to the side effect of these medicines,” he adds.
“As rheumatologists, we give methotrexate all the time. If you add the gel on top of that, even though there’s only a slight absorption, it is additive. That’s also true of the over-the-counter anti-inflammatories like Advil, Aleve and especially Tylenol,” Dr. Shaw says. “So I think the take-home message is – yes the gel has fewer side effects than diclofenac pills. But you still need to be ever vigilant to monitor for potential side effects, especially affecting the liver.”
I can't take NSAIDs as I am allergic to them, and am currently not taking any pain medication for my RA. I had been taking Aleve for pain, but had a reaction to that too. Can't get any Vicoden out of the doctor.
Too bad.
Call your doctor's office and let them know that the gel that you are using is harmful, then stop using it. Don't you just love it when the doctor says "here, try this!"
I have taken Celebrex, which was pulled, and bextra, also pulled was on 80 mg. of Morphine.had diverticulits, meds. taken away because of taking hospital drugs without permission.So I have found the best meds that work for me now Is God and prayer.Bless you all. ______________
hysterectomy..I was sick, grey and sweating...and told never to take it again..sadly nurse in charge gave it to me again a few years later-she thought I had a 'hysterical' reaction..this time I was really poorly, although I did manage to vomit on her shoes...and needed very fast
emergency treatment..no apology of course.
After a cholesterol check it was decided to give me a course of statins....a blood test
2 weeks later show my ALT level was 35 instead 5, and it took 10 weeks for my liver to recover. I am so tired of being ignored- when I say I cannot take it...which part of that is hard to understand? It is the plan of this government for everyone to take statins, so you can buy them over the counter in all pharmacies in the UK...statins are a dangerous drug!
If these medications are working well, you don't necessarily need to stop using Voltaren Gel or your diclofenac sodium pills.
Just keep an eye on your liver enzyme levels, as the FDA advises.
Many doctors do this routinely for patients on long-term prescription drug regimens because the liver is the organ responsible for clearing toxins and other kinds of chemicals from the body.
When it is healthy, it's able to handle this job just fine. But as you might imagine, the more drugs you put into your body, the more taxed the liver can become. Especially if you are also drinking alcohol, smoking cigarettes or using other recreational substances.
So my advice is the next time you see your doctor, ask if he or she has recently checked your liver enzymes levels and what the results were. If you haven't been tested recently, that may be enough to prompt your physician to order a fresh round of blood tests. (Just be sure you get the results of those tests. Ask when you can expect them--it's typically about 2 weeks--and if you don't hear from the office, call yourself to follow up.)
You may also want to ask how the specific combination of medications that you are taking may impact your liver and what you can do to keep it in good shape.
Kind regards,
Brenda Goodman
In my case, it was not working, I seen no results or improvement!
However, I tried the cream/gel, & seen major improvements!
Also after a short time usage, I no longer needed to use the cream/gel.
I would highly recommend the gel/cream, to others!
People that do not have any type of arthritis, would not be able to understand/comprehend, what kind of pain, & discomfort we are in, on a daily basis!
During the cold & winter months, the pain
intensifies! We can not predict, nor control when, why, where the pain will appear, nor how long it will remain/stay with us!
Well, I started my own herbal remedy after much searching. I started with GS500(Glucosomine/Sulfate), then replaced that with Boswella. I am now 70 and my knees are feeling pretty good and I walk without the constant pain.
ALEVE person!!! Please be careful. I irritated my esophogas from taking that. I only use some tylenol if necessary.
It totally deadens the area that hurts including areas that have muscle spasms.
If you have pain like I do...it doesn't matter about the side effects.
points to decaffinated coffee as a link to Rheumatoid Arthritis. Decaf drinkers of 4.5 cups per day were twice as likely to develop RA.
Has anyone heard whether this study was supported in more recent research ?
Thank you.
Petite Fleur--I'm with you. I LOVE Biofreeze! That stuff is great. And in Atlanta, you can even find it at some of the regular drugstores--CVS, Walgreens, etc. A great product for sure...and as for more than 6 years of using--no side effects/problems. :)
I recommend Biofreeze to anyone w/ Fibromyalgia, Arthritis, and just everyday aches/pains. Hope that helps.
Patsy
sounds safe as long as you have your doctor do a liver test often and it really works.
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