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Naprosyn/Anaprox/EC-Naprosyn/Anaprox DS
Generic Name: Naproxen
Drug Category: NSAID
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 2 years old for a maximum duration of 3 years.
| Approved Uses |
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NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS are indicated for the relief of the signs and symptoms of:
NAPROSYN Tablets and ANAPROX DS are also indicated for: the relief of signs and symptoms of:
for the management of:
Different dose strengths and formulations (e.g., tablets, suspension) of naproxen are not interchangeable. This difference should be taken into consideration when changing strengths or formulations. Dosing with NAPROSYN Tablets is not appropriate for children weighing less than 50 kilograms. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated. NAPROSYN Tablets, EC-NAPROSYN and ANAPROX DS are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Avoid the use of NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If NAPROSYN Tablets, EC-NAPROSYN and ANAPROX DS are used in patients with a recent MI, monitor patients for signs of cardiac ischemia. EC-NAPROSYN is not recommended for initial treatment of acute pain because absorption of naproxen is delayed compared to other naproxen-containing products. EC-NAPROSYN is not recommended for acute gout because of the delay in absorption. NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS are contraindicated in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients. NSAIDs, including NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS and NAPROSYN Suspension, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. NSAIDs, including NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS and NAPROSYN Suspension, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS. Some of these events have been fatal or life-threatening. Anemia is sometimes seen in patients receiving NSAIDs, including NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS and NAPROSYN Suspension. Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min). Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported. NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. 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 an NSAID, such as naproxen, increases the risk of serious gastrointestinal (GI) events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs may diminish the antihypertensive effect of ACE-inhibitors, ARBs, or beta-blockers (including propranolol). There is an increased risk of gastrointestinal bleeding when selective serotonin reuptake inhibitors (SSRIs) are combined with NSAIDs. Patients simultaneously receiving naproxen and a hydantoin, sulphonamide or sulphonylurea should be observed for adjustment of dose if required. Concomitant administration of some antacids (magnesium oxide or aluminum hydroxide) and sucralfate can delay the absorption of naproxen. As with other NSAIDs, concomitant administration of cholestyramine can delay the absorption of naproxen. Concomitant use of naproxen tablets and cyclosporine may increase cyclosporine nephrotoxicity. The concomitant use of naproxen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Naproxen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of naproxen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Naproxen may decrease platelet aggregation and prolong bleeding time. Naproxen is highly bound to plasma albumin; it thus has a theoretical potential for interaction with other albumin-bound drugs such as coumarin-type anticoagulants, sulphonylureas, hydantoins, other NSAIDs, and aspirin. Patients simultaneously receiving NAPROSYN Tablets, EC-NAPROSYN, or ANAPROX DS and a hydantoin, sulphonamide or sulphonylurea should be observed for adjustment of dose if required. There is an increased risk of gastrointestinal bleeding when selective serotonin reuptake inhibitors (SSRIs) are combined with NSAIDs. Caution should be used when NSAIDs are administered concomitantly with SSRIs. NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS are not substitutes for low dose aspirin for cardiovascular protection. Concomitant use of naproxen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy. The concomitant use of naproxen with other NSAIDs or salicylates is not recommended. Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Concomitant use of NAPROSYN Tablets, EC-NAPROSYN, or ANAPROX DS and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Naproxen may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA). The use of prostaglandin-mediated NSAIDs, including NAPROSYN Tablets, EC NAPROSYN, and ANAPROX DS, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Consider withdrawal of NSAIDs, including NAPROSYN Tablets, EC NAPROSYN and ANAPROX DS, in women who have difficulties conceiving or who are undergoing investigation of infertility. Use of NSAIDs, including NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS, in pregnant women starting at 30 weeks of gestation (third trimester). There is some evidence to suggest that when inhibitors of prostaglandin synthesis are used to delay preterm labor, there is an increased risk of neonatal complications such as necrotizing enterocolitis, patent ductus arteriosus, and intracranial hemorrhage. Naproxen treatment given in late pregnancy to delay parturition has been associated with persistent pulmonary hypertension, renal dysfunction, and abnormal prostaglandin E levels in preterm infants. Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly starting at 30-weeks of gestation, or third trimester) should be avoided. The naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma. |
| Off-label Uses |
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• Fibromyalgia. GoToSource • Lupus erythematosus. GoToSource • Migraines. GoToSource • Schizophrenia symptoms. GoToSource • Promote axonal myelination after spinal cord injury. GoToSource • Alzheimer’s disease. GoToSource • Gingival inflammation. GoToSource |
| Adverse Events |
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Urticaria (hives). GoToSource Liver injury and failure. GoToSource Aseptic meningitis (inflammation of brain and spinal cord membranes). GoToSource Photodermatitis (abnormal skin reaction to sunlight). GoToSource Stevens-johnson syndrome and toxic epidermal necrolysis (severe skin reaction). GoToSource Increased risk of heart attack or stroke. GoToSource Gastrointestinal events including bleeding, ulceration and perforation of the stomach or intestines. GoToSource Immune hemolytic anemia (immune system produces antibodies which attack red blood cells). GoToSource Kidney injury. GoToSource Hypertension (high blood pressure). GoToSource |
| Litigation |
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Lawsuits filed for gastrointestinal bleeding, heart attacks, strokes and stevens-johnson syndrome. |
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