References:
1. Voltaren Gel [package insert]. Parsippany, NJ: Novartis Consumer Health Inc., 2007. 2. VOSG-PN-310; data on file. 3. VOSG-PE-315; data on file. 4. VOSG-PN-309; data on file. 5. Hansen KE, Elliott ME. Osteoarthritis. In: DiPiro JT, Talbert RL, Yee GC, et al. Pharmacotherapy: A pathophysiologic approach. 6th ed. New York: McGraw-Hill; 2005:1685-1703. 6. Roberts LJ, Morrow JD. Analgesic-antipyretic and antiinflammatory agents and drugs employed in the treatment of gout. In: Hardman JG, Limbird LE, eds. Goodman & Gilman’s The pharmacological basis of therapeutics. 10th ed. New York: McGraw-Hill; 2001:687-731. 7. Cordero JA, Alarcon L, Escribano E, et al. A comparative study of the transdermal penetration of a series of nonsteroidal antiinflammatory drugs. J Pharm Sci. 1997;86:503-508. 8. Investigator’s Brochure; VOSG-PE-113; data on file. 9. National Institute for Health and Clinical Excellence. Osteoarthritis, the care and management of osteoarthritis in adults. NICE clinical guideline 59. London, UK. 2008;1-22. 10. Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16:137-162. 11. National Institutes of Health. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Handout on health: osteoarthritis. NIH Publication No. 06-4617. 2006;1-49. 12. The National Collaborating Centre for Chronic Conditions. Osteoarthritis: national clinical guideline for care and management in adults. London, UK. Royal College of Physicians. 2008;1-354. 13. Meadows ES, Mitchell B, Johnston J, et al. Predictors for Prescription Treatment of Women Diagnosed with Osteoporosis or Osteopenia. Presented at Society of General Internal Medicine, Pittsburgh, PA, April 2008. National Health and Wellness Survey 2008. 14. Lee YC, Shmerling RH. The benefit of nonpharmacologic therapy to treat symptomatic osteoarthritis. Curr Rheumatol Rep. 2008;10:5-10. 15. Perlman AI, Sabina A, Williams A-L, et al. Massage therapy for osteoarthritis of the knee. Arch Intern Med. 2006;166:2533-2538.
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Important Safety Information
*Voltaren® 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.
Cardiovascular Risk
- Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see Warnings and Precautions].
- Voltaren Gel is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications].
Gastrointestinal Risk
- NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events [see Warnings and Precautions].
The most common adverse reactions reported in Voltaren Gel clinical trials were application site reactions in 7% of treated patients. With all NSAIDs there may be an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.
The use of Voltaren Gel is contraindicated in patients with a known hypersensitivity to diclofenac.
Voltaren Gel should not be administered in patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.
Voltaren Gel should not be used in combination with other oral NSAIDs or aspirin because of the potential for increased adverse effects. Similarly, combined use of Voltaren Gel with other topical products, such as sunscreens and cosmetics, on the same skin area has not been tested and should be avoided because of the potential to alter local tolerability and absorption.
There is a potential for elevation in liver function tests during treatment with diclofenac containing products.
Safety and effectiveness in pediatric patients have not been established.
Please see full Prescribing Information for Warnings and Contraindications.
