Voltaren Gel - 10 Things You Should Know

Understanding How to Safely Use Voltaren Gel

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Voltaren Gel was the first prescription topical treatment for osteoarthritis approved by the Food and Drug Administration. Voltaren Gel, a nonsteroidal anti-inflammatory medication in topical form, is mostly used on knees and hands. Here are 10 important facts you should know about Voltaren Gel.

1 - Voltaren Gel delivers effective pain relief and has a favorable safety profile.

The systemic absorption of Voltaren Gel (1% diclofenac sodium in topical gel formulation) is 94% less than oral diclofenac (generic for Voltaren).

Consequently, the risk of serious gastrointestinal and cardiovascular side effects associated with oral NSAIDs are considerably less with the topical formulation.

2 - The effectiveness and safety of Voltaren Gel was studied in more than 900 patients with knee or hand osteoarthritis.

The FDA approval was based on several studies, including two randomized, double-blind, placebo-controlled efficacy (effectiveness) studies and a 12-month safety study.

3 - Voltaren Gel significantly reduced pain levels.

After 6 weeks of treatment in an efficacy study of people with hand osteoarthritis, pain levels were reduced by 46%. In a 12-week study of people with knee osteoarthritis, Voltaren Gel reduced pain levels by 51%.

4 - Adverse reactions can occur with Voltaren Gel.

The most common adverse reactions reported in clinical trials were application site reactions in 7% of study participants treated with Voltaren Gel.

The prescribing information for Voltaren Gel provides warnings and precautions for serious adverse reactions as well. Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. The elderly, people with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE inhibitors should use Voltaren Gel cautiously.

Hypertension can occur with NSAID treatment making it important to monitor blood pressure. Fluid retention and edema may also occur. If an anaphylactoid reaction occurs, use should be discontinued immediately. NSAIDs can cause serious skin adverse events, too, including exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis which can be fatal.

5 - Since Voltaren Gel is an NSAID, it carries the same cardiovascular risks.

As with all NSAIDs, there may be an increased risk of serious or possibly fatal cardiovascular events, heart attack, or stroke with the use of Voltaren Gel. Despite the fact that the risk is less than with oral NSAIDS, there still is a risk.

6 - The usual gastrointestinal side effects associated with NSAIDs also apply to Voltaren Gel.

NSAID use can cause an increased risk of serious gastrointestinal events which may include bleeding, ulcers, and perforation of the stomach and intestines. These adverse events could possibly be fatal. Again, despite the fact that the risk is less than with oral NSAIDS, there still is a risk.

7 - Certain patients with known medical problems should not use Voltaren Gel.

Voltaren Gel should not be used by patients with known hypersensitivity to diclofenac. It also should not be used by patients who developed asthma, urticaria, or allergic reactions after taking aspirin or NSAIDs. Voltaren Gel should also not be used by patients who had coronary artery bypass surgery in order to treat perioperative pain.

8 - You should avoid using Voltaren Gel along with other NSAIDs.

Voltaren Gel should not be used together with oral NSAIDs or aspirin because of an increased risk of adverse events. The risk of side effects increases with the increased absorption of the active ingredients in NSAIDs. Just as topical NSAID cream should not be used with oral NSAIDs, two different oral NSAIDs should not be taken together.

9 - Voltaren Gel should also not be used in combination with other topical agents.

If you are using cosmetics or sunscreen, don't use Voltaren Gel, too. The combinations have not been tested and, if topical agents are combined, there is potential to change how Voltaren Gel is tolerated and absorbed.

10 - Voltaren Gel will mostly benefit patients who cannot take oral NSAIDs.

After you have just learned how Voltaren Gel should not be used and who should not use it, you may be wondering who should use it. Patients who suffer gastrointestinal side effects from oral NSAIDs are clearly the ones who will benefit most from Voltaren Gel. Discuss it with your doctor and see if it is appropriate for you.

UPDATE (2009) - The FDA added a labeling change to Voltaren Gel to warn about possible hepatic effects.

Source:

Voltaren Gel Receives US Regulatory Approval. Novartis. October 22, 2007.
http://cws.huginonline.com/N/134323/PR/200710/1161352_5_2.html

Voltaren Gel. Prescribing Information. July 2009.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022122s006lbl.pdf

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