ST. LOUIS--(BUSINESS WIRE)--Mar. 30, 2012--
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).
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WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
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Cardiovascular Risk
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• 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.
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• PENNSAID is contraindicated in the perioperative setting of
coronary artery bypass graft (CABG) surgery.
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Gastrointestinal Risk
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• 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.
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IMPORTANT RISK INFORMATION
PENNSAID is also contraindicated in patients:
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with a known hypersensitivity to diclofenac sodium or any other
component of PENNSAID
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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]
Source: Covidien
Covidien
Lynn Phillips, 314-654-3263
Manager, Media Relations
Pharmaceuticals
lynn.phillips@covidien.com
or
Coleman
Lannum, CFA, 508-452-4343
Vice President
Investor Relations
cole.lannum@covidien.com
or
Stephen
Littlejohn, 314-654-6595
Vice President
Communications
Pharmaceuticals
stephen.littlejohn@covidien.com
or
Todd
Carpenter, 508-452-4363
Director
Investor Relations
todd.carpenter@covidien.com
