If you work in the pharmaceutical industry you of all people should be well informed of the serious dangers presented in taking Voltaren "gel"
Have you not observed the black box warning or the FDA initiated Healthcare Professional warning letter released by Endo in 2009.
This letter is to inform you that the prescribing information for all diclofenac containing products has been updated at the request of the Food and Drug Administration (FDA). These changes have been included in the Warnings and Precautions section of the Voltaren® Gel (diclofenac sodium topical gel) 1% prescribing information, specifically Section 5.3 Hepatic Effects. This section provides information regarding the potential for elevations in liver tests during treatment with all products containing diclofenac sodium.
Almost all meaningful elevations in transaminases were detected before patients became symptomatic. Abnormal tests occurred during the first 2 months of therapy with diclofenac in 42 of the 51 patients in all trials who developed marked transaminase elevations. ___
Novartis themselves have also clearly under-lined some of the more serious risks associated with using this gel:
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal.
Voltaren® Gel, like other NSAIDs, may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death.
Voltaren® Gel, like other NSAIDs, can cause GI discomfort and, rarely, more serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death
Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, patients should be instructed to stop therapy with Voltaren® Gel and seek immediate medical therapy [see Warnings and Precautions
Voltaren® Gel, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and even death.
In late pregnancy, as with other NSAIDs, Voltaren® Gel should be avoided because it will cause premature closure of the ductus arteriosus.
Are you even aware of the serious dangers presented to any Asthma sufferer who risks using this deadly outdated drug? ___
September 2011 - Canadian Study
WOMEN more than double the risk of miscarriage by taking anti-inflammatory drugs such as Nurofen and Voltaren in early pregnancy, research shows.
Australia's drug regulator, the Therapeutic Goods Administration, last night said it would review the study to assess whether to strengthen warnings about the possible effects of taking such drugs during pregnancy.
Australian experts said the drugs were already known to increase the risk of birth defects, but the latest research was further cause for concern.
I would how many Australian's are already aware that it increases the risk of birth defects and more than doubles the risk of miscarriage? ___
September 2010 - Denmark Study
There are calls today for one of Australia's top-selling painkillers to be banned, after another study linked it to an increased chance of stroke in healthy people.
Commonly sold as Voltaren, diclofenac is available in a number of brands and is as dangerous as the arthritis drug Vioxx, according to the author of the study.
It found diclofenac increased the risk of stroke by 86 per cent in people not previously thought to be at risk.
The study's author, cardiologist Dr Gunnar Gislason, has said the public needs increased awareness about the cardiovascular risks of these drugs even in healthy people.
In Denmark, diclofenac is only available on prescription but in Australia Voltaren is sold over the counter.
Clinical pharmacologist Professor David Henry is the chief executive of the Toronto-based Institute for Clinical Evaluative Sciences and Adjunct Professor at the University of Newcastle in New South Wales.
He says Voltaren should be withdrawn from sale in Australia.
"The drug has passed its use-by date," he said.
"It is an old drug, it's turned out to be toxic. There are safer alternatives. There's no reason to have it on the market, whether it's prescription or over the counter." ___
If you care to see what the future may hold for Voltaren gel maybe you should have a look at the Class Actions filed against Merck's much safer drug, Vioxx.
The TGA who have been called on by many experts to ban this highly dangerous killer over the past 10 years should hang their heads in shame
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