Diclofenac sodium topical - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Diclofenac sodium topical. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events • 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 [ see Warnings and Precautions ]. • Diclofenac sodium topical gel is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications and Warnings and Precautions ]. Gastrointestinal Bleeding, Ulceration, and Perforation • 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 a greater risk for serious GI events [ see Warnings and Precautions ]. WARNING: RISK OF SERIOUS CARDIOVASCULAR EVENTS AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. • 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. • Diclofenac sodium topical gel is contraindicated in the set
5 WARNINGS AND PRECAUTIONS • Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs. • Exacerbation of Asthma Related to Aspirin Sensitivity: Diclofenac sodium topical gel is contraindicated in patients with aspirin-sensitive asthma.
Monitor patients with pre-existing asthma (without aspirin sensitivity). • Serious Skin Reactions: Discontinue diclofenac sodium topical gel at first appearance of skin rash or other signs of hypersensitivity. ( 5.3 , 5.15 ) • Hepatoxicity: Inform patients of warning signs and symptoms of hepatotoxicity.
Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. • Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs.
Monitor blood pressure. ( 5.7 , 7 ) • Heart Failure and Edema: Avoid use of diclofenac sodium topical gel in patients with severe heart failure. • Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.
Avoid use of diclofenac sodium topical gel in patients with advanced renal disease. • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue diclofenac sodium topical gel and evaluate clinically. • Fetal Toxicity: Limit use of NSAIDs, including diclofenac sodium topical gel, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction.
Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus. ( 5.11 , 8.1 ) • Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. ( 5.12 , 7 ). • Photosensitivity: Avoid exposure of treated area(s) to natural or artificial sunlight. • Exposure to Eyes and Mucosal Membranes: Avoid contact of diclofenac sodium topical gel with eyes and mucosal membranes. • Oral Nonsteroidal Anti-inflammatory Drugs: Avoid concurrent use with oral NSAIDs.
5.1 Anaphylactic Reactions Diclofenac has been associated with anaphylactic reactions in patients with and without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma [see Contraindications and Warnings and Precautions ].
Seek emergency help if an anaphylactic reaction occurs.
5.2 Exacerbation of Asthma Related to Aspirin Sensitivity 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, diclofenac sodium topical gel is contraindicated in patients with this form of aspirin sensitivity.
When diclofenac sodium topical gel is used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma.
5.3 Serious Skin Reactions NSAIDs, including diclofenac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
NSAIDs can also cause fixed drug eruption (FDE).
FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.
These serious events may occur without warning.
Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of diclofenac sodium topical gel at the first appearance of skin rash or any other sign of hypersensitivity.
Diclofenac sodium topical gel is contraindicated in patients with previous serious skin reactions to NSAIDs.
Do not apply diclofenac sodium topical gel to open skin wounds, infections, or exfoliative dermatitis, as it may affect absorption and tolerability of the drug [see Contraindications ] .
5.4 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, including myocardial infarction (MI) and stroke, which can be fatal.
Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs.
The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.
However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate.
Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment.
The increase in CV thrombotic risk has been observed most consistently at higher doses.
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible.
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