Voltaren Gel-FDA warning

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straydog
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Date Joined Feb 2003
Total Posts : 13481
   Posted 12/5/2009 9:54 PM (GMT -7)   
Hey gang, had an alert today from the FDA website with a warning on Voltaren Gel. It seems to be messing with people livers and they are advising drs to send their patients out for labs to monitor the liver. I don't know if anyone here using this just wanted to do a FYI just in case.
 

crohns disease dx 2002 & small bowel resection, still looking for remission whatever that is, chronic pain 22 yrs, added ulcerative colitis 6-05 to the mix, high blood pressure 28 yrs, aortic heart valve insuffiency, depression, osteoarthritis, osteoporosis lumbar spine, scoliosis lumbar spine, peripheral neuropathy hands & feet, COPD & on oxygen therapy, lupus & psoriasis and psoratic arthritis. Several other health issues just not enough room to list it all. Too many surgeries to list and too many medications to list. Currently on 17 different daily medications. Intrathecal pain pump implanted June 05.


Chutz
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Date Joined Jan 2005
Total Posts : 9090
   Posted 12/5/2009 10:09 PM (GMT -7)   
Since I had no idea what this is I looked it up and thought I'd add it to your post, straydog. Thanks so much for posting this warning.


Viktareb Gel is indicated for the relief of the pain of osteoarthritis of joints amenable
to topical treatment, such as the knees and those of the hands. Voltaren Gel has not
been evaluated for use on the spine, hip, or shoulder.

Generic Name: diclofenac topical (dye KLO feh nak)
Brand Names: Flector Patch, Solaraze, Voltaren Topical

Voltaren Gel is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Voltaren works by reducing hormones that cause inflammation and pain in the body.

Diclofenac topical skin patch (Flector Patch) is used to treat pain caused by minor sprains, strains, or bruising.

Voltaren Gel (diclofenac topical 1%) is used to treat joint pain in the hands, wrists, elbows, knees, ankles, or feet caused by osteoarthritis. Voltaren Gel may not be effective in treating arthritis pain elsewhere in the body.

Solaraze Gel (diclofenac topical 3%) is used to treat warty overgrowths of skin (actinic keratoses) on sun-exposed areas of the body.

Voltaren Gel may also be used for other purposes not listed in this medication guide.

Here's the web site where most of this information came from:
www.drugs.com/voltaren-gel.html


Chutz
The three grand essentials of happiness are: something to do, someone to love, and something to hope for. — Alexander Chalmers

(\o/)Co-Moderator Fibromyalgia & Chronic Pain Forums
(/|\)
Fibromyalgia, PTSD, UC, Diabetic on insulin, collapsed disk, arthritis scattered around and a few other delights.


Dagger
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Date Joined Apr 2008
Total Posts : 1522
   Posted 12/5/2009 11:09 PM (GMT -7)   
Wow - thanks for the warning. My husband just picked up a case from the pharmacy an Thursday. He got hurt at work a few weeks ago and the doc just prescribed Valtaren Gel for the pain and inflammation in his leg.

My husband has only used it a few times and planned to start applying it regularly this weekend to see if helped with the discomfort and swelling. He's not in enough pain to risk liver problems. I am really glad workman's comp picked up the $185.00 for this stuff.

melliflious
Regular Member


Date Joined Dec 2009
Total Posts : 79
   Posted 12/5/2009 11:15 PM (GMT -7)   
Oh wow. I actually just put mine on right before I read this. It is kind of my first step in my line of pain meds. I will call my md tomorrow to see what she recommends. So glad I found you guys!

Jenna
Pain Issue: Sub-scapular bursitis, scapular dyskinesia, nerve damage down left arm, shoulder and neck
Treatment: PT, Tens Unit, Oxycodone, Diazepan, Hydrocodone-APAP, Tramadol, Voltaren/Duac gel


Dagger
Veteran Member


Date Joined Apr 2008
Total Posts : 1522
   Posted 12/5/2009 11:15 PM (GMT -7)   
I just read the new FDA warning and it's scary because apparently this med can destroy your liver in the first month of treatment. Nope, my husband can take Motrin, that's as scary as I need right now.

Straydog, I can't thank you enough. I researched this drug last week before the FDA warning came out so who knows when we would have found out about it. I'm curious as to whether the prescribing doctor will call about it or test my husband's liver enzymes next week during the follow up visit.

Lindaloo
Veteran Member


Date Joined Sep 2006
Total Posts : 1713
   Posted 12/5/2009 11:44 PM (GMT -7)   
I use the voltaren gel and it works great on my feet for the fibro pain. I already get my liver enzymes checked for my other medications. Thanks for the update.

Lindaloo
Co-Moderator Chronic Pain and Fibromyalgia Forums
 
Believe in yourself.  Be kind to fellow humans and animals.  Take time to smell the flowers and the coffee.
And by all means, when you are down, ask me for help.  I will be there.
 
Linda


Pete trips again!
Veteran Member


Date Joined Nov 2006
Total Posts : 1899
   Posted 12/6/2009 4:33 AM (GMT -7)   
Yikes!!! I've been using the stuff for a couple months now on my knees, hands, feet, shoulders and sometimes neck, hip and back!!! It seems every time I try a new anti inflamitory something bad happens! It has worked so well especially on my knees & hands I should have known!! I'll stop using it for now!!

So I guess I'll be needing another blood test or do they suggest some other lab test? Like Rosanna Danna used to say on the old SNL back in the 70's >> "It's allways something!"
Thanks for the heads up!!

Pete

punchfit
Regular Member


Date Joined Nov 2009
Total Posts : 89
   Posted 12/6/2009 5:07 AM (GMT -7)   
Thanks Straydog,

Holly Gosh, i use Voltaren Gel on my back & Neck & shoulder also.
I will check with my Dr this wednesday.

I also have a few friends who use it for sports injuries, i will let them know also.
Thanks for the heads up.
Hope you are well.
Cheers

Leisa - Punchfit

punchfit
Regular Member


Date Joined Nov 2009
Total Posts : 89
   Posted 12/6/2009 5:16 AM (GMT -7)   
Straydog,

Can you post the FDA WEBSITE please , i cannot see to find it.
I would like to read over it.
Thankyou
Cheers
Leisa

aimsgirl16
Forum Moderator


Date Joined Jun 2008
Total Posts : 1469
   Posted 12/6/2009 9:17 AM (GMT -7)   
Oh Wow! Thanks Straydog! I had no idea!

Mrs. Dani
Veteran Member


Date Joined Jun 2009
Total Posts : 2787
   Posted 12/6/2009 9:45 AM (GMT -7)   
Oh my goodness, thank you susie

 

 

Two roads diverged in a yellow wood,
And sorry I could not travel both
And be one traveler, long I stood

 

 


mrsm123
Veteran Member


Date Joined Dec 2007
Total Posts : 1228
   Posted 12/6/2009 12:06 PM (GMT -7)   
I just picked up mine too. Three tubes of the stuff. Guess it's going into the garbage. A $70.00 copay in the trash............sheesh
Sandi
PLIF/TLIF Fusion w/Instrumentation L4-5 Spondololysthesis L4-5.Laminectomies L4-5, foraminal stenosis L3-4, L4-5, L5-S1, herniations L3-4, L4-5, L5-S1, central canal stenosis L3-4, L4-5 and L5-S1
POST OP CES 3/30-06
Neurogenic Bladder and Bowel, bilateral numbness legs and feet
Revision for failed Back surgery, pseudoarthrosis L4-5, hemilaminectomies L3-4, L4-5, L5-S1, bmp added to revision fusion, replaced two bent screws that were reversing out of vertebrae - August 2, 2007
On going back pain and neuropathic pain, failed back surgery, consult for scs, decided not to do that at this point.
Adhesive Arachnoiditis also......just what I didn't need..9/08- adding bilateral ulnar neuropathy with severe compression to the mix. They want me to see a surgeon for ulnar nerve surgery, but I'm not biting.
I've seen enough surgeons over the last few years.
Avascular necrosis of left wrist- maybe hips too


Dagger
Veteran Member


Date Joined Apr 2008
Total Posts : 1522
   Posted 12/6/2009 1:17 PM (GMT -7)   
If you are using it for a chronic condition, and especially if it's helping, you may want to talk to your doc before discontinuing it. The warnings on most meds are scary so we always need to make sure the benefits outweigh the risks. So many meds can damage the liver but we take them anyway (Tylenol.) It's difficult to gauge the risk for your particular situation based on the FDA information, your doctor can help.

At least with this drug, you can just stop using it until you talk to your doc. It's scarier when they release info like this on a med that you can't just stop taking.

(We chose to have my husband stop using it immediately. He has a relatively minor injury that can be treated with other meds. In his case the risks far outweigh the benefits.)

straydog
Forum Moderator


Date Joined Feb 2003
Total Posts : 13481
   Posted 12/6/2009 1:21 PM (GMT -7)   
the website is: www.fda.com

You can go into their site and tab points of interest and get email alerts on just about anything. I have two warnings from Medtronic on my pain pump and my first dr had no clue they were potential problems. I also tab the medicatioons because of my wacky system not working well with drugs.

I suggest anyone using this gel to go to the website and read it, then call your dr Monday morning. It's so sad the stuff that works always has a glitch.
 

crohns disease dx 2002 & small bowel resection, still looking for remission whatever that is, chronic pain 22 yrs, added ulcerative colitis 6-05 to the mix, high blood pressure 28 yrs, aortic heart valve insuffiency, depression, osteoarthritis, osteoporosis lumbar spine, scoliosis lumbar spine, peripheral neuropathy hands & feet, COPD & on oxygen therapy, lupus & psoriasis and psoratic arthritis. Several other health issues just not enough room to list it all. Too many surgeries to list and too many medications to list. Currently on 17 different daily medications. Intrathecal pain pump implanted June 05.


Tirzah
Veteran Member


Date Joined Jul 2008
Total Posts : 2284
   Posted 12/6/2009 5:05 PM (GMT -7)   
Thanks Susie!

I think it's so strange that the oral Voltaren has warnings, but apparently the gel form is less clear. Still, though, I have always had my liver checked a couple times a year since cirrhosis is VERY prevalent in my family history (8 relatives died from it, including one who didn't drink a day in her life). I've been on Voltaren gel for 2 years & haven't ever had any problems with my liver (& I also take Lyrica). My PM said it depends on how large the area is over which it is applied, how much is applied & how often it is applied, in addition to what other medications (prescription or OTC) are being taken, alcohol consumption, smoking & any predisposition/genetic factors.

I'm always in favor of everyone having all the information about medications. Still, risk of any liver issues (mild to severe) resulting from Voltaren was measured at 2% of patients. The manufacturer says that using Voltaren together with anti-epileptics or antibiotics is riskier than Voltaren alone. I agree that it is important to be careful & if someone is feeling very sick on this medication they need to go straight to the doctor or ER, but like Dagger points out ... the other options may be as bad or worse. I get concerned when people decide to stop a medication without discussing it with their doctor. I know from my own experience that when I have done this is the past, it usually leads to more injections & sometimes stronger meds like Torodol (which can cause death from bleeding in just over a week -- which is much riskier for me, since I am slow to clot).

The FDA site gives less information that the manufacturer's site (which, at least presently, discloses the risk of hepatoxicity after only one month of use & recommends testing liver function every 4-8 weeks of treatment). Here's the link to both the manufacturer's website & the FDA:

www.voltarengel.com/docs/Voltaren-PI-10-19.pdf
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyalertsforHumanMedicalProducts/ucm193047.htm

take care all,
frances

SnowyLynne
Veteran Member


Date Joined Apr 2004
Total Posts : 1539
   Posted 12/6/2009 5:32 PM (GMT -7)   
I was ordered Voltaren gel for hand pain after surgery.Bad Idea! it depressed my breathing,scared me to death.I threw it away...........
SnowyLynne


Draka
Regular Member


Date Joined Jun 2009
Total Posts : 256
   Posted 12/7/2009 1:41 PM (GMT -7)   
I used this regularly too.... thanks for the scoop!
Lisa
Slight reversal of the normal cervical curvature. Ther eis a 2mm antherolisthesis of C3 with respect to C4, a 2mm retrolisthesis of C5 with respect to C6 and a 2mm retrolisthesis of C6 with respect to C7
Degenerative changes present at multiple levels as follows:
C2-C3 osteophytes medial to the right intervertebral foramen and involving the right uncovertebral joint with minimal to moderate foraminal narrowing.
C3-C4 herniation fo the disc medial to the right intervertebral foramen and encroaching uponthe medial aspect fo teh foramen measuring approx. 2.5mm in the AP diameter. There is marked compression of the right nerve root sleeve. There are osteophytes involving the right uncoverterbral joint with moderate to foraminal stenosis. There is minimal anterolisthesis of C3 with respect to C4
C4-C5 herniation of the disc in the midline measuring approx. 2.5mm in the AP diameter woth minimal flattening to the ventral aspect of the cord. There are osteophytes involving the right uncovertebral joint with moderate foraminal narrowing
C5-C6 posterocentral herniation of the disc measuring approx. 3mm in the AP diameter with flattening of the ventral aspect of the cord. There are osteophytes involving the right uncovertebral joint woth moderate foraminal narrowing. There is minimal retrolistesis of C5 with respect to C6
C6-C7 minimal retrolisthesis of C6 with respect to C7. There is minimal diffuse bulging fo the annulus measuring approx. 2mm in the AP diameter. There are osteophytes involving the uncovertebral joint bilaterally with minimal bilateral foraminal narrowing.

Been off all medications for almost one month... couldn't deal with the side effects.... now only using 5% Lidocaine patches


straydog
Forum Moderator


Date Joined Feb 2003
Total Posts : 13481
   Posted 12/7/2009 2:22 PM (GMT -7)   
When ever these alerts come out folks using a product should contact their dr and see what he thinks needs to be done. Never stop something w/o consulting with the dr that rx'd it.
 

crohns disease dx 2002 & small bowel resection, still looking for remission whatever that is, chronic pain 22 yrs, added ulcerative colitis 6-05 to the mix, high blood pressure 28 yrs, aortic heart valve insuffiency, depression, osteoarthritis, osteoporosis lumbar spine, scoliosis lumbar spine, peripheral neuropathy hands & feet, COPD & on oxygen therapy, lupus & psoriasis and psoratic arthritis. Several other health issues just not enough room to list it all. Too many surgeries to list and too many medications to list. Currently on 17 different daily medications. Intrathecal pain pump implanted June 05.


Lindaloo
Veteran Member


Date Joined Sep 2006
Total Posts : 1713
   Posted 12/7/2009 4:31 PM (GMT -7)   
Absolutely good advice, Straydog. I will not stop using Voltaren gel until I talk it over with my doctor. I doubt she will see the need to do so, as I don't use it every day or even nearly that frequently.

Thanks for the good advice. And thanks for the update too.

Lindaloo
Co-Moderator Chronic Pain and Fibromyalgia Forums
 
Believe in yourself.  Be kind to fellow humans and animals.  Take time to smell the flowers and the coffee.
And by all means, when you are down, ask me for help.  I will be there.
 
Linda


Chartreux
Veteran Member


Date Joined Aug 2006
Total Posts : 9622
   Posted 12/7/2009 8:31 PM (GMT -7)   
My PM doctor just gave me a sample of the voltaren gel, inside are cards as to how much to apply, I will give it a try...
I guess like anything else if done in moderation this should be okay....
hugz
**********************************************
* Asthma, Allergies, Osteoarthritis, Spinal Stenosis, Degenative Disc (Lower Lumbar S1-L3 and Cervical C5,C6, C8 and T1), Fibromyalgia, Gerd,
Enlarged Pituitary Gland, Sjogren's, Ocular Migraines, mild carpel tunnel, ect.... "Would be nice if we could use the edit button in real life"...

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PAlady
Veteran Member


Date Joined Nov 2007
Total Posts : 6795
   Posted 12/7/2009 8:57 PM (GMT -7)   
I don't use voltaren, but I do know that a lot of the meds we take can affect the liver. My neurologist checks my liver enzymes at least once/year, along with a general CBC. One of the boxes circled as to need for this is that I'm on multiple medications long term. He did it even when I was only taking my seizure meds. So yes, as Susie says, check with your doctor, and if it's one of the things that's really helping you, maybe you just need your doctor to follow your liver enzymes regularly. A lot of us probably need that anyway, but I'm only basing that on my experience. It's just an educated guess.

PaLady

FallsMill
New Member


Date Joined Jun 2010
Total Posts : 1
   Posted 6/30/2010 7:07 PM (GMT -7)   
Good to know. I was given a prescription for the Flector patch. I found out the cost and did not get it filled. I want to see what the side effects are and is it worth $177. I don't have insurance so I use the discount card which is %75 off price of drug. Do you think I could get a sample of this new drug, no generic is out yet

Thanks for any reply.

God bless

J

Retired Mom
Veteran Member


Date Joined Feb 2010
Total Posts : 1753
   Posted 6/30/2010 8:20 PM (GMT -7)   
I've been using this too and it does seem to help some but lately I'm starting to itch on my hands a few minutes after using it so I had decided not to refill and to just us it if absolutely necessary. Thanks for the heads up!
Retired Mom

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