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Voltaren XR

Generic Name: Diclofenac Sodium
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 40 months.

Approved Uses

Indicated for:

• Relief of the signs and symptoms of osteoarthritis 

• Relief of the signs and symptoms of rheumatoid arthritis

Avoid the use of VOLTAREN-XR in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events.

Avoid the use of VOLTAREN-XR in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure.

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 adverse events including inflammation, 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.

Strategies to Minimize the GI Risks in NSAID-treated patients:

  • Use the lowest effective dose for the shortest possible duration
  • Avoid administration of more than one NSAID at a time
  • Avoid use in patients at higher risk unless benefits are expected to outweigh the increased risk of bleeding
  • For such patients, as well as those with active GI bleeding, consider alternate therapies other than NSAIDs
  • Remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy
  • If a serious GI adverse event is suspected, promptly initiate evaluation and treatment, and discontinue VOLTAREN-XR until a serious GI adverse event is ruled out
  • In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding

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.

VOLTAREN-XR is contraindicated in:

  • In patients with a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patient
  • In the setting of coronary artery bypass graft (CABG) surgery

Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including VOLTAREN-XR, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women.

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

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. Fluid retention and edema have been observed in some patients treated with NSAIDs. Use of diclofenac may blunt the CV effects of several therapeutic agents used to treat these medical conditions (e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]).

NSAIDs, including diclofenac, 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 VOLTAREN-XR. Some of these events have been fatal or life-threatening. 

NSAIDs, including VOLTAREN-XR, 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, thiazides diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs.

NSAIDs, including VOLTAREN-XR, 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.

When co-administered with voriconazole (inhibitor of CYP2C9, 2C19 and 3A4 enzyme), the Cmax and AUC of diclofenac increased by 114% and 78%, respectively.

NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).

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

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

Concomitant use of VOLTAREN-XR and cyclosporine may increase cyclosporine nephrotoxicity.

Concomitant use of VOLTAREN-XR and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).

In late pregnancy, as with other NSAIDs, Voltaren-XR should be avoided because it may cause premature closure of the ductus arteriosus. VOLTAREN XR is contraindicated in patients with this form of aspirin sensitivity. Avoid use of NSAIDs, including VOLTAREN-XR,  in pregnant women starting at 30 weeks of gestation (third trimester).

Based on available data, diclofenac may be present in human milk.

GoToSource

Off-label Uses

• Juvenile rheumatoid arthritis. GoToSource

• Control of cancer pain. GoToSource

• Ankylosing spondylitis. GoToSource

• Primary dysmenorrhea and reduction of menstrual bleeding. GoToSource

• Acute migraines. GoToSource

• Bursitis and tendonitis. GoToSource

• Use in patients under the age of 18. GoToSource 

• Alzheimer’s disease. GoToSource 

• Acute renal colic. GoToSource

• Augment antipsychotic treatment to reduce schizophrenia symptom severity. GoToSource 

• Reduce frequency and severity of post-ERCP pancreatitis. GoToSource 

• Acute postoperative pain. GoToSource

Adverse Events

Myocardial infarction and stroke. GoToSource

Elevated creatinine (signifies impaired kidney function or kidney disease), elevated LFT (possible inflammation and damage to the liver) and hypertension (high blood pressure). GoToSource

Inflammation, bleeding, ulceration, and perforation of the stomach or intestines. Elderly patients are at greater risk for serious gastrointestinal events. GoToSource

Liver damage. GoToSource

Clostridium difficile associated disease (colon infection causing severe diarrhea). GoToSource

Thrombocytopenia (low blood platelet count). GoToSource 

Increased risk of kidney impairment after laparoscopic radical nephrectomy in elderly patients. GoToSource 

Convulsions, disorientation, hallucination and loss of consciousness. GoToSource 

Stevens-johnson syndrome (severe skin reaction). GoToSource 

Spontaneous non-gastrointestinal bleeding. GoToSource 

Neonatal severe pulmonary hypertension and transient right-sided hypertrophic cardiomyopathy. GoToSource 

Pneumonitis. GoToSource 

Kidney damage. GoToSource 

Hyperkalemic quadriparesis (high potassium level causing muscle weakness). GoToSource 

Angioedema (rapid swelling) and hemodynamic shock (severe blood and fluid loss making the heart unable to pump enough blood to the body). GoToSource 

Reye syndrome (condition causing swelling in the liver and brain). GoToSource 

Hepatitis (inflammation of the liver) and death. GoToSource

Litigation

Lawsuits filed for heart attacks and strokes. 

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 28, 2024