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Voltaren(R) Gel Receives US Regulatory Approval as the First Approved Topical Prescription Treatment for Pain Associated with Osteoarthritis
Date:10/22/2007

of the bones in joints - such as knees, hands, elbows, wrists, ankles and feet - which allows for easy movement. When cartilage erodes, bones can rub together, resulting in pain and loss of free movement in the joint.(3) The most common symptoms include pain, joint soreness, stiffness and deterioration of overall coordination, posture and walking.

Arthritis and related conditions, such as osteoarthritis, cost the US economy nearly $128 billion per year in medical care and indirect expenses, including lost wages and production.(4)

Despite the high prevalence of osteoarthritis, there is no cure for this disease, which tends to progressively reduce mobility and the overall health state in the affected patients.

About Voltaren Gel

Voltaren Gel provides 1% diclofenac sodium in a topical gel formulation. It is a non-steroidal anti-inflammatory (NSAID) medication indicated for the pain of osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands. Voltaren Gel delivers highly effective pain relief with a favorable safety profile as its systemic absorption is 94% less than comparable oral diclofenac treatment.

Important safety information

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 to patients who have experienced asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions
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SOURCE Novartis
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