Diclofenac Potassium (Page 3 of 8)

5.11 Medication Overuse Headache


Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, nonsteroidal anti-inflammatory drugs or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

5.12 Fetal Toxicity

Premature Closure of Fetal Ductus Arteriosus
Avoid use of NSAIDs, including diclofenac potassium, in pregnant women at about 30 weeks gestation and later. NSAIDs, including diclofenac potassium, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.
Oligohydramnios/Neonatal Renal Impairment
Use of NSAIDs, including diclofenac potassium, at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit diclofenac potassium use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if diclofenac potassium treatment extends beyond 48 hours. Discontinue diclofenac potassium if oligohydramnios occurs and follow up according to clinical practice [see Use in Specific Population ( 8.1)] .

5.13 Hematologic Toxicity

Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect upon erythropoiesis. If a patient treated with diclofenac potassium has any signs or symptoms of anemia, monitor hemoglobin or hematocrit. NSAIDs, including diclofenac potassium, may increase the risk of bleeding events. Concomitant use of warfarin and other anticoagulants, antiplatelet agents (e.g., aspirin), and serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Monitor these patients and any patient who may be adversely affected by alterations in platelet function for signs of bleeding [see Drug Interactions ( 7)] .

5.14 Masking of Inflammation and Fever

The pharmacological activity of diclofenac potassium in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.

5.15 Laboratory Monitoring

Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and a chemistry profile periodically [see Warnings and Precautions ( 5.2, 5.3, 5.6)] . Discontinue diclofenac potassium if abnormal liver tests or renal tests persist or worsen.

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
• Cardiovascular Thrombotic Events [see Warnings and Precautions ( 5.1)]
• GI Bleeding, Ulceration and Perforation [see Warnings and Precautions ( 5.2)]
• Hepatotoxicity [ see Warnings and Precautions ( 5.3)]
• Hypertension [see Warnings and Precautions ( 5.4)]
• Heart Failure and Edema [see Warnings and Precautions ( 5.5)]
• Renal Toxicity and Hyperkalemia [see Warnings and Precautions ( 5.6)]
• Anaphylactic Reactions [see Warnings and Precautions ( 5.7)]
• Serious Skin Reactions [see Warnings and Precautions ( 5.9)]
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions ( 5.10)]
• Medication Overuse Headache [see Warnings and Precautions ( 5.11)] • Hematologic Toxicity [see Warnings and Precautions ( 5.13)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of a single dose of diclofenac potassium was evaluated in 2 placebo-controlled trials with a total of 634 migraine patients treated with diclofenac potassium for a single migraine headache. Following treatment with diclofenac potassium (either diclofenac potassium or diclofenac potassium immediate-release tablets [as a control]), 5 subjects(0.8%) withdrew from the studies; following placebo exposure, 1 subject (0.2%) withdrew. The most common adverse reactions (i.e., that occurred in 1% or more of diclofenac potassium-treated patients) and more frequent with diclofenac potassium than with placebo were nausea and dizziness (see Table 1). Table 1: Adverse Reactions With Incidence >1% and Greater Than Placebo in Studies 1 and 2 Combined

Adverse Reactions Diclofenac Potassium for Oral Solution N=634 Placebo N=646
Gastrointestinal
Nausea 3% 2%
Nervous System
Dizziness 1% 0.5%

The most common adverse events resulting in discontinuation of patients following diclofenac potassium dosing in controlled clinical trials were urticaria (0.2%) and flushing (0.2%). No withdrawals were due to a serious reaction.

6.2 Postmarketing Experience


The following adverse reactions have been identified during post approval use of diclofenac or other NSAIDs. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse Reactions Reported With Diclofenac and Other NSAIDs
In patients taking diclofenac or other NSAIDs, the most frequently reported adverse reactions occurring in approximately 1% to 10% of patients are: GI reactions (including abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers [gastric/duodenal], and vomiting), abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes, and tinnitus.
Additional adverse reactions reported in patients taking NSAIDs include occasionally:
Body as a Whole: Fever, infection, sepsis
Cardiovascular System: Congestive heart failure, hypertension, tachycardia, syncope
Digestive System: Dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice
Hemic and Lymphatic System: Ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia
Metabolic and Nutritional: Weight changes
Nervous System: Anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo
Respiratory System: Asthma, dyspnea
Skin and Appendages: Alopecia, photosensitivity, sweating increased
Special Senses: Blurred vision
Urogenital System: Cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure
Other adverse reactions in patients taking NSAIDs, which occur rarely, are:
Body as a Whole: Anaphylactic reactions, appetite changes, death
Cardiovascular System: Arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis
Digestive System: Colitis, eructation, liver failure, pancreatitis
Hemic and Lymphatic System: Agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia
Metabolic and Nutritional: Hyperglycemia
Nervous System: Convulsions, coma, hallucinations, meningitis
Respiratory System: Respiratory depression, pneumonia
Skin and Appendages: Angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria Special Senses: Conjunctivitis, hearing impairment

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