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Covidien Collaborates with Arthritis Foundation on Patient-Education Initiatives

^{Published on 2010-11-22 06:10:47 - Market Wire}
 

ST. LOUIS--([ BUSINESS WIRE ])--The Arthritis Foundation and Covidien (NYSE: COV) have joined forces to help advance awareness and support for millions of people suffering from osteoarthritis in the United States. Covidien will serve as a sponsor of the Foundationa™s Leta™s Move Together Movement Tracker, an educational and physical activity resource for those suffering from arthritis. The tracker provides patients with personalized, step-by-step support to reach their exercise goals and stay physically activea"an important component of effective arthritis treatment.^1,2

"The Foundation is committed to identifying ways to cure and treat arthritis, but prevention is also central to our mission. Regular physical activity, which is encouraged by the Movement Tracker, can play a great role in prevention of the most common form of arthritis"

The Leta™s Move Together Movement Tracker is an online tool members can use to set personal goals, benchmark their physical activity and keep motivated to stay active. Social media applications for the tracker include a widget, enabling users to display progress updates on their Arthritis Foundation community page, Facebook or MySpace pages.

aThe Foundation is committed to identifying ways to cure and treat arthritis, but prevention is also central to our mission. Regular physical activity, which is encouraged by the Movement Tracker, can play a great role in prevention of the most common form of arthritis,a said Rick Bell, Managing Director of Cause Development with the Arthritis Foundation. aWe are excited about working with Covidien on this important initiative.a

Launched in January 2009, the Leta™s Move Together campaign is a nationwide movement designed to inspire people to move every day to prevent or treat arthritis. The campaign encourages daily physical activity for better health and participation in the Arthritis Foundationa™s local Arthritis Walksa"an annual event that promotes fun and fitness.

aKnee osteoarthritis affects more than 10 million Americansa"many of whom live with significant pain that affects their daily function,a said Herbert Neuman, M.D., Vice President of Medical Affairs and Chief Medical Officer, Pharmaceuticals, Covidien. aOur goal, in conjunction with the Arthritis Foundation, is to provide educational and useful tools, like the Movement Tracker, to patients seeking treatment-plan support and long-term success.a

Knee OA is among the five leading causes of disability in adults.^3,4 According to the Arthritis Foundation, it is a chronic condition in which joint cartilage, the smooth tissue that cushions the bone and allows easy joint movement, breaks down, leading to pain, stiffness and loss of movement in the joint.⁵

Mallinckrodt, a Covidien company, has introduced PENNSAID^® (diclofenac sodium topical solution) 1.5% w/w, a topical non-steroidal anti-inflammatory drug (NSAID). PENNSAID is indicatedfor treatment of the signs and symptoms of osteoarthritis of the knee(s).For more information on PENNSAID, including Important Risk Information and boxed warning, see below.

About the Arthritis Foundation

The Arthritis Foundation ([ www.arthritis.org ]) is the leading health organization addressing the needs of the 50 million adults and 300,000 children living with arthritis, the nationa™s most common cause of disability. The Foundation helps individuals take control of arthritis by providing public health education; pursuing public policy and legislation; supporting research and conducting evidence-based programs to improve the quality of life for those living with arthritis.

About Covidien

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2010 revenue of $10.4 billion, Covidien has approximately 42,000 employees worldwide in more than 60 countries, and its products are sold in over 140 countries. Please visit [ www.covidien.com ] to learn more about our business.

About PENNSAID

PENNSAID (diclofenac sodium topical solution) 1.5% w/w is a NSAID in a vehicle solution containing the penetrating agent DMSO.^1,2 PENNSAID was developed to help increase the effective, local delivery of pain relief to patients suffering from knee osteoarthritis, a disorder impacting an estimated 10 million patients in the United States.⁶ PENNSAID is the only FDA-approved topical NSAID for the treatment of the signs and symptoms of knee osteoarthritis which demonstrated statistically significant differences in all three primary efficacy endpoints: pain and physical function (WOMAC), patient overall health assessment (POHA) and patient global assessment (PGA) of knee osteoarthritis.^1,2,3,7

IMPORTANT RISK INFORMATION ABOUT PENNSAID

Cardiovascular Risk

aNonsteroidal 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.

aPENNSAID is contraindicated in the perioperative setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

aNSAIDs 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.

PENNSAID is contraindicated in patients:

• with a known hypersensitivity to diclofenac sodium or any other component of PENNSAID
• who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal anaphylactic-like reactions to NSAIDs have been reported in such patients.

Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID should be discontinued immediately if abnormal liver tests persist or worsen.

Use with caution in patients with fluid retention or heart failure. Hypertension can occur with NSAID treatment. Monitor blood pressure closely with PENNSAID treatment.

Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. Use PENNSAID with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE-inhibitors.

Should not be used in pregnant or lactating women and is not approved for use in pediatric patients.

Anaphylactoid reactions may occur in patients without prior exposure to PENNSAID. NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.

The most common treatment-related adverse events in patients receiving PENNSAID were application site skin reactions including dry skin (32%), contact dermatitis characterized by skin erythema and induration (9%), contact dermatitis with vesicles (2%) and pruritus (4%). In a long term safety study, contact dermatitis occurred in 13% and contact dermatitis with vesicles in 10% of patients, generally within the first 6 months of exposure, leading to a withdrawal rate for an application site event of 14%. Other common adverse events greater than placebo include: dyspepsia (9%), abdominal pain (6%), flatulence (4%), diarrhea (4%) and nausea (4%).

Do not apply to open wounds. Protect treated knee(s) from natural or artificial sunlight. Topicals such as sunscreen and bug repellant may be applied after PENNSAID treated knee(s) are completely dry. Avoid contact of PENNSAID with eyes and mucous membranes. Wash and dry hands after use.

Concurrent use with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.

See [ Full Prescribing Information ]for additional Important Risk Information.

PENNSAID is a registered trademark of Nuvo Research Inc.

¹ Minor MA. Exercise in the treatment of osteoarthritis. Rheum Dis Clin North Am 25(2):397-415, 1999.

² Ytterberg SR, Mahowald ML, Krug HE. Exercise for arthritis. Baillieres Clin Rheumatol 8:161-189, 1994.

³ Osteoarthritis. Centers for Disease Control and Prevention Web site. [ http://www.cdc.gov/arthritis/basics/osteoarthritis.htm ]. Updated February 4, 2010. Accessed April 12, 2010.

⁴ Guccione AA, Felson DT, Anderson JJ, et al. The effects of specific medical conditions on the functional limitations of elders in the Framingham Study. Am J Public Health. 1994;84:351-358.

⁵ Arthritis Foundation. Osteoarthritis Fact Sheet. [ http://www.arthritis.org/media/newsroom/media-kits/Osteoarthritis_fact_sheet.pdf ] [ Last Accessed April 2010]

⁶ Parmet S, Lynm C, Glass RM (2003). Osteoarthritis of the knee. JAMA, 289(8), 1068.

⁷ Tugwell PS, Wells GA, Shainhouse J. Equivalence study of a topical diclofenac solution (PENNSAID) compared with oral diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial. Journal of Rheumatology, 2004;31(10), 2002-12.