You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
INDICATIONS AND USAGE
PENNSAID® (diclofenac sodium topical solution) 2% w/w is a nonsteroidal anti-inflammatory drug (NSAID) used for treating the pain of osteoarthritis of the knee(s).
IMPORTANT SAFETY INFORMATION
WARNING: HEART, STOMACH AND INTESTINE RISK
- Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious heart clotting events, heart attack, and stroke, which can kill you. This risk may increase with longer use. Patients with heart disease or risk factors for heart disease may be at greater risk.
- PENNSAID should not be used if you are in the hospital for certain heart surgeries.
Stomach and Intestine Risk
- NSAIDs cause an increased risk of serious stomach and intestine events including bleeding, ulcers, and holes in the stomach or intestines, which can kill you. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious stomach and intestine events.
- DO NOT USE PENNSAID if you:
- are in the hospital for certain heart surgeries
- know you are allergic to diclofenac sodium or any other ingredient of PENNSAID.
- have experienced asthma, hives, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, allergic reactions, that will rarely kill you, to NSAIDs have been reported in such patients
WARNINGS AND PRECAUTIONS
- To minimize the potential for increased risk of serious heart events while being treated with an NSAID, use the lowest effective dose for the shortest duration possible
- 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 use of NSAIDs can result in severe kidney injury. Use PENNSAID with caution in patients at greatest risk of this reaction, including the elderly, those with impaired kidney function, heart failure, liver dysfunction, and those taking diuretics and ACE-inhibitors (certain blood pressure medicines)
- Severe allergic reactions may occur without prior use of PENNSAID. NSAIDs can cause serious skin reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can kill you
- Wash and dry hands before and after use. Avoid contact of PENNSAID with the eyes, nose and mouth
- PENNSAID was not studied under the conditions of heat application, complete covering bandages, or exercise; therefore, concurrent use of PENNSAID under these conditions is not recommended
- Do not:
- Apply PENNSAID to open wounds
- Shower for at least 30 minutes after applying PENNSAID
- Wear clothing over the PENNSAID treated knee until the treated knee is dry
- Protect treated knee(s) from natural or artificial sunlight
- Protect treated knee(s) from sunlight (real and tanning booths)
- Topicals, such as sunscreen and bug repellent, should not be used until after PENNSAID treated knee(s) are completely dry
- Do not use with oral NSAIDs unless your doctor says it is OK and you have lab tests to check your progress
- There is no consistent evidence that regular use of aspirin lessens the increased risk of serious heart events, such as heart clotting, heart attack, and stroke associated with NSAID use. As with all NSAIDs, regular administration of PENNSAID and aspirin is not generally recommended because of the potential of increased risks
- The most common adverse events in a phase 2 clinical trial of PENNSAID 2% were application site reactions, such as dryness (22%), peeling (7%), redness (4%), itching (2%), pain (2%), skin hardening (2%), rash (2%), and scabbing (<1%). Other adverse reactions occurring in >1% of patients receiving PENNSAID 2% included bladder infection (3%), bruising (2%), sinus congestion (2%), and nausea (2%)
- The most common treatment-related adverse events in patients receiving PENNSAID 1.5% were application site skin reactions including dry skin (32%), skin reaction characterized by redness and hardening (9%), skin reaction with blisters (2%) and itching (4%). In a long term safety study, skin reactions occurred in 13% and skin reactions with blisters 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: stomach upset (9%), stomach pain (6%), gas (4%), diarrhea (4%) and nausea (4%)
USE IN SPECIFIC POPULATIONS
- PENNSAID should not be used in pregnant woman or in women who are breastfeeding and is not approved for use in children
See additional Important Safety Information in Full Prescribing Information.