Posted on 02/09/2010 10:14:42 PM PST by neverdem
Warnings about potential hepatotoxicity risks associated with use of diclofenac have been added to the labels of all products containing the nonsteroidal anti-inflammatory drug, the Food and Drug Administration said.
A notice posted on the FDA's MedWatch site said that the manufacturers—Endo Pharmaceuticals Inc. and Novartis Consumer Health Inc.—had revised the “hepatic effects” section of the diclofenac topical gel label to include new warnings and precautions about the potential for elevated liver function tests (LFTs) during treatment with diclofenac products, including the topical gel formulation marketed as Voltaren Gel 1%.
There have been postmarketing reports of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure in patients treated with diclofenac, according to the FDA. Some of the reported cases have been fatal or resulted in liver transplantation. Cases of drug-induced hepatotoxicity have been reported during the first month of treatment, but can “occur at any time during treatment with diclofenac,” the FDA statement said.
As of March 2009, there were no postmarketing reports of hepatotoxicity in the FDA's Adverse Event Reporting System (AERS) for the gel formulation, according to an FDA spokesperson.
Because patients may develop severe hepatoxicity without symptoms, the FDA and the revised label both recommend that clinicians should periodically measure transaminase levels in patients taking diclofenac long term. The optimum schedule for checking transaminase levels is not known, but clinical trial data and postmarketing experience indicate that levels should be monitored within 4–8 weeks of initiating treatment, the FDA notice said.
The labeling changes include the recommendation that diclofenac should be stopped immediately if a patient has persistent or worsening abnormal LFTs, develops clinical signs and/or symptoms consistent with liver disease, or has systemic signs of liver disease.
The hepatic effects section says that elevations of one or more liver function tests “may occur” during diclofenac treatment, which “may progress, may remain unchanged, or may be transient with continued therapy.”
Voltaren Gel 1% is approved for relief of osteoarthritis pain in joints “amenable to topical treatment,” such as the knees and hands, but has not been evaluated for use in the spine, hip, or shoulder joints, according to the label.
I’m glad I haven’t had a prescription for Voltaren refilled in the almost 9 years since my back surgery. It’s the best non-narcotic analgesic I’ve ever been prescribed.
According to Wikipedia it also has antibiotic activity. That’s odd.
Vioxx was wonderful too. My doctor knew about the cardiovascular risks years before the public stink about the risks led to it being pulled from the market.
My mom never turned in her Vioxx pills, because it was the best pain medication she had for her knee problems. Ultimately it was the removal of Vioxx from the market that pushed my mom to have one knee replaced.
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Luckily, I didn’t take much, since it did nothing for my pain.
I needed narcotics for the last 4 weeks before I had my surgery, but Voltaren worked pretty well for the almost 5 years before my surgery.
I loved Vioxx. After taking it for about 3 days I looked at my honey and said “I feel like myself!”. I cried when they took it off the market.
Me neither. Nothing helps me. I still have half a bottle of it. Right now I take aspirin everyday together with either ibuprofen, naproxen or acetaminophen. I rotate them every day. It doesn't take the pain away but works best of anything so far.
Voltaren gel is currently making my life passable for my rotten damaged sprained arthritic right knee. I apply a little to the area that hurts the most.
The doc prescribed me a huge jar of these after my back surgery for a ruptured disk, but I did a search on the risk and I dumped them out.
Hepatoxicity is a dying liver, which is fatal
No drug is 100% effective or 100% safe for 100% of the population.
I have the patches, which work wonderfully on my pain, but I am too afraid of the side effects to use them.
“Voltaren gel is currently making my life passable for my rotten damaged sprained arthritic right knee. I apply a little to the area that hurts the most.”
‘As of March 2009, there were no postmarketing reports of hepatotoxicity in the FDA’s Adverse Event Reporting System (AERS) for the gel formulation, according to an FDA spokesperson.’
‘Because patients may develop severe hepatoxicity without symptoms, the FDA and the revised label both recommend that clinicians should periodically measure transaminase levels in patients taking diclofenac long term. The optimum schedule for checking transaminase levels is not known, but clinical trial data and postmarketing experience indicate that levels should be monitored within 4–8 weeks of initiating treatment, the FDA notice said.’
I started using the Voltaren patches until my surgery and was able tolerate the lingering pain.
The surgery was a success, but the wear and tear arthritis was still there and seemed to get a little worse after my twice daily walks to keep my knees in shape. So I started using the Voltaren Gel 2-3 times a day on my repaired knee. I have no GI problems and the wear and tear arthritis seems to be under control re minimal if any chronic pain. I haven’t had the need for an Aleve since I started using the Voltaren Gel.
Basically my experience exactly. I use a tiny amount of Voltaren gel on the sore spot of my right knee and I get definite relief for 6 hours.
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