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Feldene

Generic Name: Piroxicam
Drug Category: NSAID
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 5 years.

Approved Uses

Indicated for:

• Relief of the signs and symptoms of osteoarthritis

• Relief of the signs and symptoms of rheumatoid arthritis

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

FELDENE is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

FELDENE is 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.

Avoid the use of FELDENE in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If FELDENE is used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Avoid the use of FELDENE in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If FELDENE is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

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, including piroxicam, can cause serious skin adverse reactions 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 FELDENE. Some of these events have been fatal or life-threatening.

NSAIDs, including FELDENE, can lead to new onset of hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs.

Fluid retention and edema have been observed in some patients treated with NSAIDs.

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.

Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis.

Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment.

Elevations of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (three or more times the upper limit of normal [ULN]) have been reported in approximately 1% of NSAID-treated patients in clinical trials. In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported.

Elevations of ALT or AST (less than three times ULN) may occur in up to 15% of patients treated with NSAIDs including piroxicam.

Because of reports of adverse eye findings with nonsteroidal anti-inflammatory agents, it is recommended that patients who develop visual complaints during treatment with FELDENE have ophthalmic evaluations.

A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs. Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, FELDENE is contraindicated in patients with this form of aspirin sensitivity.

Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. Concomitant use of FELDENE and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding.

NSAIDs, including FELDENE, may increase the risk of bleeding events. Comorbid conditions such as coagulation disorders, concomitant use of warfarin, other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk.

Piroxicam and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of piroxicam and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.

Monitor patients with concomitant use of FELDENE with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding.

NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure.

NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients.

The concomitant use of piroxicam with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.

NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance.

Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).

Concomitant use of FELDENE and cyclosporine may increase cyclosporine nephrotoxicity.

Concomitant use of piroxicam 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 piroxicam with other NSAIDs or salicylates is not recommended.

Concomitant use of FELDENE and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity.

Concomitant use of corticosteroids with FELDENE may increase the risk of GI ulceration or bleeding.

NSAIDs are associated with reversible infertility. Consider withdrawal of FELDENE in women who have difficulties conceiving.

Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.

Piroxicam is excreted in human milk.

GoToSource

Off-label Uses

• Use in patients under the age of 18. GoToSource 

• Renal colic. GoToSource 

• Chemoprevention of colon cancer. GoToSource 

• Non-melanoma skin cancer. GoToSource 

• TMJ arthralgia. GoToSource 

• Use with ifenprodil for parkinson’s disease, alcoholism, drug addiction and cerebral stroke. GoToSource 

• Prophylactic and postoperative treatment for arthroscopic procedures. GoToSource 

• Soft tissue injuries. GoToSource

Adverse Events

⚠️  Patients with CYP2C9 gene variant have increased exposure to piroxicam and increased risk of side effects.

Liver necrosis. GoToSource

Hearing loss and tinnitus (ringing or buzzing in ears). GoToSource

Peptic ulcer and upper gastrointestinal hemorrhages. GoToSource

Stevens-johnson syndrome (life-threatening skin condition). GoToSource

Phototoxic reactions. GoToSource

Toxic epidermal necrolysis (life-threatening skin condition). GoToSource

Elevated blood pressure. GoToSource

Pancreatitis (inflammation of the pancreas). GoToSource

Infertility. GoToSource

Use during the third trimester of pregnancy increases the risk of premature closure of the ductus arteriosus. GoToSource

Kidney failure. GoToSource

Hyperkalemia (high blood potassium levels). GoToSource

Haematemesis (vomiting blood), melaena (black tarry stool) and edema (swelling). GoToSource

Anemia. GoToSource

Increased risk of heart attack and stroke. GoToSource

Litigation

Lawsuits filed for stevens-johnson syndrome and toxic epidermal necrolysis. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024