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Osteoarthritis Treatment Guidelines Issued by American College of Rheumatology Discussed Use of Topical NSAIDS for Patients 75 and Older

Friday, March 30, 2012

Osteoarthritis Treatment Guidelines Issued by American College of Rheumatology Discussed Use of Topical NSAIDS for Patients 75 and Older08:00 EDT Friday, March 30, 2012 ST. LOUIS (Business Wire) -- The American College of Rheumatology (ACR) Subcommittee on Osteoarthritis Guidelines has approved and issued several updates to clinical practice guidelines for the treatment of osteoarthritis (OA). The new guidelines, published in the April issue of Arthritis Care & Research, conditionally recommend that healthcare providers consider topical nonsteroidal anti-inflammatory drugs (NSAIDs) as one option for the initial management of knee OA, along with other treatments including acetaminophen, oral NSAIDs, tramadol and intraarticular corticosteroid injections. In addition, the guidelines strongly recommend the use of oral or topical NSAIDs or intraarticular corticosteroid injections in patients with an unsatisfactory clinical response to full-dose acetaminophen, and furthermore strongly recommend topical over oral NSAIDs in those patients aged 75 years or older initiating NSAID therapy.1 Commenting on the new guidelines, Marc C. Hochberg, MD, MPH, said, “Osteoarthritis is the most common form of arthritis affecting adults in the United States and is the principal cause of musculoskeletal pain, limitation in physical activity and reduction in health-related quality of life. It is important for all primary care providers and specialists taking care of patients with osteoarthritis to recognize that there is a lot that can be offered to the patient to reduce their pain and improve their function.” Dr. Hochberg is professor of medicine and epidemiology and public health, University of Maryland School of Medicine, Baltimore, and chair of the Task Force that developed the new ACR recommendations. Knee OA 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 and loss of physical function.2 Mallinckrodt LLC, a Covidien company, markets PENNSAID® (diclofenac sodium topical solution) 1.5% w/w, a topical NSAID. PENNSAID is the only U.S. Food and Drug Administration (FDA)-approved topical NSAID for the treatment of the signs and symptoms of knee OA, which demonstrated statistically significant differences in pain and physical function compared to placebo. “Knee OA pain is one of the top five causes of disability in American adults,” said Alfredo Bozzini, Interim Chief Medical Officer, Pharmaceuticals, Covidien. “We support the ACR treatment guidelines and believe topical NSAIDs, like PENNSAID, provide an effective option for reducing knee OA pain.” “The American College of Rheumatology osteoarthritis treatment guidelines propose to advance the use of topical NSAIDs beyond what the American Geriatric Society and American Academy of Orthopedic Surgeons recommend,” said Dr. Joseph Markenson, attending physician at the Hospital for Special Surgery and professor of clinical medicine at Weill Cornell Medical College. “The updated guidelines are helpful to physicians in their clinical practice, especially when seeing patients over 75 years of age.” For Important Risk Information on PENNSAID, including boxed warning, see below. About Osteoarthritis OA is a chronic condition characterized by the breakdown of cartilage in the joint. Cartilage cushions the ends of the bones in joints – such as knees, hands, elbows, wrists, ankles and feet - which allows for easy movement. When this cartilage erodes, bones can rub together, resulting in pain and loss of free movement in the joint. Today, an estimated 27 million Americans live with OA.2 The most common symptoms include pain, joint soreness, stiffness and deterioration of overall coordination, posture and walking. Despite the high prevalence of OA, there is no cure for this disease, which tends to progressively reduce mobility and the overall health state in affected patients. About PENNSAID® PENNSAID is the only FDA-approved topical NSAID for the treatment of knee OA 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 of knee OA. INDICATION PENNSAID is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). x   WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK   xxxxCardiovascular Riskxxxx• Non-steroidal 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.xxxxxx• PENNSAID is contraindicated in the perioperative setting of coronary artery bypass graft (CABG) surgery.xxxxGastrointestinal Riskxxxx• 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.xxxIMPORTANT RISK INFORMATION PENNSAID is also 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. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. PENNSAID is a registered trademark of Nuvo Research Inc. WOMAC is a registered trademark of Nicholas Bellamy. 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 2011 revenue of $11.6 billion, Covidien has 41,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business. 1 Hochberg M, Altman R, et al. American College of Rheumatology 2012 Recommendations for the Use of Nonpharmacologic and Pharmacologic Therapies in Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care & Research. 2012;64:465-474. 2 Arthritis Foundation. Osteoarthritis Fact Sheet. http://www.arthritis.org/media/newsroom/media-kits/Osteoarthritis_fact_sheet.pdf [Last Accessed January 10, 2012] CovidienLynn Phillips, 314-654-3263Manager, Media RelationsPharmaceuticalslynn.phillips@covidien.comorColeman Lannum, CFA, 508-452-4343Vice PresidentInvestor Relationscole.lannum@covidien.comorStephen Littlejohn, 314-654-6595Vice PresidentCommunications Pharmaceuticalsstephen.littlejohn@covidien.comorTodd Carpenter, 508-452-4363DirectorInvestor Relationstodd.carpenter@covidien.com