References
| 1. | IMS NPA Audit, September 2011; data on file. |
| 2. | Voltaren Gel [package insert]. Parsippany, NJ: Novartis Consumer Health, Inc.; 2009. |
| 3. | Formulary Compass, March 2011; data on file. |
| 4. | Peniston JH, Gold MS, Alwine LK. An open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis. Phys Sportsmed. 2011;39:31-38. |
| 5. | American Academy of Orthopaedic Surgeons. Clinical Practice Guideline: Treatment of Osteoarthritis of the Knee (non-arthroplasty); 2008. |
| 6. | National Institute for Health and Clinical Excellence (NICE). Osteoarthritis: the care and management of osteoarthritis in adults. NICE Clinical Guideline 59. |
| 7. | Jordan KM, Arden NK, Doherty M, et al. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003;62:1145-1155. |
| 8. | 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. |
| 9. | VOSG-PN-310; data on file. |
| 10. | Altman RD, Drieser R, Fisher CL, et al. Diclofenac sodium gel in patients with primary hand osteoarthritis: a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2009;36:1991-1999. |
| 11. | Kienzler J-L, Gold M, Nollevaux F. Systemic bioavailability of topical diclofenac sodium gel 1% versus oral diclofenac sodium in healthy volunteers. J Clin Pharmacol. 2010;50:50-61. |
Indication
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.
Important Safety Information
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.
NSAIDs, including Voltaren Gel, can lead to high blood pressure or worsening of high blood pressure, which may add to the increased risk of heart attack and stroke.
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.
To report SUSPECTED ADVERSE EVENTS, contact Novartis Consumer Health, Inc. at
1-800-452-0051 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
1-800-452-0051 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
