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warnings and cautions
5 WARNINGS AND PRECAUTIONS Cardiovascular Thrombotic Events: Serious and potentially fatal cardiovascular thrombotic events, myocardial infarction, and stroke can occur with NSAID treatment. Use the lowest effective dose of Flector Patch in patients with known CV disease or risk factors for CV disease. ( 5.1 ) Gastrointestinal (GI) Effects: NSAIDs can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation. Prescribe Flector Patch with caution in those with a prior history of ulcer disease or gastrointestinal bleeding. ( 5.2 ) Hepatic Effects: Elevation of one or more liver tests may occur during therapy with Flector Patch. Discontinue Flector Patch immediately if abnormal liver tests persist or worsen. ( 5.3 ) Hypertension can occur with NSAID treatment. Monitor blood pressure closely with Flector Patch treatment. ( 5.4 ) Congestive Heart Failure and Edema: Use Flector Patch with caution in patients with fluid retention or heart failure. ( 5.5 ) Renal effects: Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. Use Flector Patch 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. ( 5.6 ) Anaphylactic reactions may occur in patients with the aspirin triad and in patients with or without known sensitivity to NSAIDs or prior exposure to Flector Patch. Anaphylaxis type reactions have been reported with NSAID products, including diclofenac products such as Flector Patch. ( 5.7 ) Skin Reactions: NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. ( 5.8 ) Pregnancy: Avoid the use of Flector Patch at or beyond 30 weeks gestation. ( 5.9 ) Preexisting Asthma: Do not administer to patients with aspirin sensitive asthma and use with caution in patients with preexisting asthma. ( 5.13 ) New or used Flector Patch contains sufficient diclofenac to result in serious harm following accidental exposure by a child or pet. ( 5.14 ) Eyes: Avoid contact of Flector Patch with eyes and mucosa. ( 5.15 ) Oral NSAIDs: Avoid concurrent use with oral NSAIDs. ( 5.16 ) 5.1 Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Inform patients about the signs and/or symptoms of serious CV events and the steps to take if they occur. Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke [see Contraindications (4) ] . There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and NSAIDs, such as diclofenac, does increase the risk of serious GI events [see Warnings and Precautions (5.2) ]. 5.2 Gastrointestinal Effects – Risk of GI Ulceration, Bleeding, and Perforation NSAIDs, including diclofenac, can cause serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk. Prescribe NSAIDs, including Flector Patch, with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population. To minimize the potential risk for an adverse GI event, use the lowest effective dose for the shortest possible duration. Physicians and patients should remain alert for signs and symptoms of GI ulceration and bleeding during diclofenac therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. For high risk patients, consider alternate therapies that do not involve NSAIDs. 5.3 Hepatic Effects Borderline elevations (less than 3 times the upper limit of the normal [ULN] range) or greater elevations of transaminases occurred in about 15% of oral diclofenac-treated patients in clinical trials of indications other than acute pain. Of the markers of hepatic function, ALT (SGPT) is recommended for the monitoring of liver injury. In clinical trials of an oral diclofenac – misoprostol combination product, meaningful elevations (i.e., more than 3 times the ULN) of AST (SGOT) occurred in about 2% of approximately 5,7000 patients at some time during diclofenac treatment (ALT was not measured in all studies). In an open-label, controlled trial of 3,700 patients treated for 2-6 months, patients with oral diclofenac were monitored first at 8 weeks and 1,200 patients were monitored again at 24 weeks. Meaningful elevations of ALT and/or AST occurred in about 4% of the 3,700 patients and included marked elevations (>8 times the ULN) in about 1% of the 3,700 patients. In this open-label study, a higher incidence of borderline (less than 3 times the ULN), moderate (3-8 times the ULN), and marked (>8 times the ULN) elevations of ALT or AST was observed in patients receiving diclofenac when compared to other NSAIDs. Elevations in transaminases were seen more frequently in patients with osteoarthritis than in those with rheumatoid arthritis. Almost all meaningful elevations in transaminases were detected before patients became symptomatic. Abnormal tests occurred during the first 2 months of therapy with oral diclofenac in 42 of the 51 patients in all trials who developed marked transaminase elevations. In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of therapy, but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation. Measure transaminases (ALT and AST) periodically in patients receiving long-term therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. The optimum times for making the first and subsequent transaminase measurements are not known. Based on clinical trial data and postmarketing experiences, monitor transaminases within 4 to 8 weeks after initiating treatment with diclofenac. However, severe hepatic reactions can occur at any time during treatment with diclofenac. If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g. eosinophilia, rash, abdominal pain, diarrhea, dark urine, etc.), discontinue Flector Patch immediately. To minimize the possibility that hepatic injury will become severe between transaminase measurements, inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms), and the appropriate action patients should take if these signs and symptoms appear. To minimize the potential risk for an adverse liver related event in patients treated with Flector Patch, the lowest effective dose should be used for the shortest duration possible. Exercise caution when prescribing Flector Patch with concomitant drugs that are known to be potentially hepatotoxic (e.g., acetaminophen, certain antibiotics, anti-epileptics). Caution patients to avoid taking unprescribed acetaminophen while using Flector Patch. 5.4 Hypertension NSAIDs, including Flector Patch, can lead to new onset or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Use Flector Patch, with caution in patients with hypertension. Monitor blood pressure (BP) closely during the initiation of treatment and throughout the course of therapy. Patients taking ACE inhibitors, thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. 5.5 Congestive Heart Failure and Edema Fluid retention and edema have been observed in some patients taking NSAIDs, including Flector Patch. Use Flector Patch with caution in patients with fluid retention or heart failure. 5.6 Renal Effects Use caution when initiating treatment with Flector Patch in patients with considerable dehydration. Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state. No information is available from controlled clinical studies regarding the use of Flector Patch in patients with advanced renal disease. Therefore, treatment with Flector Patch is not recommended in these patients with advanced renal disease. If Flector Patch therapy is initiated, close monitoring of the patient's renal function is advisable. 5.7 Anaphylactic Reactions As with other NSAIDs, anaphylactic reactions may occur both in patients with the aspirin triad and in patients without known sensitivity to NSAIDs or prior exposure to Flector Patch. Do not prescribe Flector Patch to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Anaphylaxis type reactions have been reported with NSAID products, including diclofenac products, such as Flector Patch [see Contraindications (4) and Warnings and Precautions (5.13) ]. Seek emergency help in cases where an anaphylactic reaction occurs. 5.8 Skin Reactions NSAIDs, including Flector Patch, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin manifestations, and discontinue use of the drug at the first appearance of skin rash or any other signs of hypersensitivity. 5.9 Pregnancy Starting at 30 weeks gestation, Flector Patch, and other NSAIDs, should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur [see Use in Specific Populations (8.1) ]. 5.10 Corticosteroid Monitoring Flector Patch cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Slowly taper patients on prolonged corticosteroid therapy if a decision is made to discontinue corticosteroids. 5.11 Inflammation The pharmacological activity of Flector Patch in reducing inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions. 5.12 Hematological Effects Anemia is sometimes seen in patients receiving NSAIDs. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including Flector Patch, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia. NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Carefully monitor patients receiving Flector Patch who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants. 5.13 Preexisting Asthma Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, do not administer Flector Patch to patients with this form of aspirin sensitivity and use with caution in patients with preexisting asthma. 5.14 Accidental Exposure in Children Even a used Flector Patch contains a large amount of diclofenac epolamine (as much as 170 mg). The potential therefore exists for a small child or pet to suffer serious adverse effects from chewing or ingesting a new or used Flector Patch. It is important for patients to store and dispose of Flector Patch out of the reach of children and pets. 5.15 Eye Exposure Avoid contact of Flector Patch with eyes and mucosa. Advise patients that if eye contact occurs, immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour. 5.16 Oral Nonsteroidal Anti-inflammatory Drugs Concomitant use of oral and topical NSAIDs may result in a higher rate of hemorrhage, more frequent abnormal creatinine, urea and hemoglobin. Do not use combination therapy with Flector Patch and an oral NSAID unless the benefit outweighs the risk. 5.17 Monitoring Because serious GI tract ulcerations and bleeding can occur without warning symptoms, monitor for signs or symptoms of GI bleeding. Check CBC and a chemistry profile periodically in patients on long-term treatment with NSAIDs. Discontinue Flector Patch if abnormal liver tests or renal tests persist or worsen.