FLECTOR (Page 3 of 8)

5.10 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as FLECTOR. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue FLECTOR and evaluate the patient immediately

5.11 Fetal Toxicity

Premature Closure of Fetal Ductus Arteriosus

Avoid use of NSAIDs, including FLECTOR, in pregnant women at about 30 weeks gestation and later. NSAIDs, including FLECTOR, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.

Oligohydramnios/Neonatal Renal Impairment

Use of NSAIDs, including FLECTOR, 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 FLECTOR use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if FLECTOR treatment extends beyond 48 hours. Discontinue FLECTOR if oligohydramnios occurs and follow up according to clinical practice [ see Use in Specific Populations (8.1) ].

5.12 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 on erythropoiesis. If a patient treated with FLECTOR has any signs or symptoms of anemia, monitor hemoglobin or hematocrit.

NSAIDs, including FLECTOR, may increase the risk of bleeding events. Co-morbid 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. Monitor these patients for signs of bleeding [ see Drug Interactions (7) ].

5.13 Masking of Inflammation and Fever

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

5.14 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)].

5.15 Accidental Exposure in Children

Even a used FLECTOR contains a large amount of diclofenac epolamine (as much as 170 mg). The potential therefore exists for a small child or pet to suffer serious adverse effects from chewing or ingesting a new or used FLECTOR. It is important for patients to store and dispose of FLECTOR out of the reach of children and pets.

5.16 Eye Exposure

Avoid contact of FLECTOR with eyes and mucosa. Advise patients that if eye contact occurs, immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour.

5.17 Oral Nonsteroidal Anti-inflammatory Drugs

Concomitant use of oral and topical NSAIDs may result in a higher rate of hemorrhage, more frequent abnormal creatinine, urea and hemoglobin. Do not use combination therapy with FLECTOR and an oral NSAID unless the benefit outweighs the risk.

6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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.

Adult Clinical Trials Experience

In controlled trials during the premarketing development of FLECTOR, approximately 600 patients with minor strains, sprains, and contusions were treated with FLECTOR for up to two weeks.

Adverse Events Leading to Discontinuation of Treatment

In the controlled trials, 3% of patients in both the FLECTOR and placebo groups discontinued treatment due to an adverse event. The most common adverse events leading to discontinuation were application site reactions, occurring in 2% of both the FLECTOR and placebo groups. Application site reactions leading to dropout included pruritus, dermatitis, and burning.

Common Adverse Events

Overall, the most common adverse events associated with FLECTOR treatment were skin reactions at the site of treatment. Table 1 lists all adverse events, regardless of causality, occurring in ≥ 1% of patients in controlled trials of FLECTOR.

A majority of patients treated with FLECTOR had adverse events with a maximum intensity of “mild” or “moderate.”

Table 1. Common Adverse Events (by body system and preferred term) in ≥ 1% of Patients treated with FLECTOR or Placebo *
Category Diclofenac
N=572
Placebo
N=564
N Percent N Percent
*
The table lists adverse events occurring in placebo-treated patients because the placebo was comprised of the same ingredients as FLECTOR except for diclofenac. Adverse events in the placebo group may therefore reflect effects of the non-active ingredients.
Includes: application site dryness, irritation, erythema, atrophy, discoloration, hyperhidriosis, and vesicles.
Includes: gastritis, vomiting, diarrhea, constipation, upper abdominal pain, and dry mouth.
§
Includes: hypoesthesia, dizziness, and hyperkinesias.
Application Site Conditions 64 11 70 12
Pruritus 31 5 44 8
Dermatitis 9 2 3 <1
Burning 2 <1 8 1
Other 22 4 15 3
Gastrointestinal Disorders 49 9 33 6
Nausea 17 3 11 2
Dysgeusia 10 2 3 <1
Dyspepsia 7 1 8 1
Other 15 3 11 2
Nervous System Disorders 13 2 18 3
Headache 7 1 10 2
Paresthesia 6 1 8 1
Somnolence 4 1 6 1
Other § 4 1 3 <1

Foreign labeling describes that dermal allergic reactions may occur with FLECTOR treatment. Additionally, the treated area may become irritated or develop itching, erythema, edema, vesicles, or abnormal sensation.

Pediatric Clinical Trials Experience

In one open-label trial, 104 male and female pediatric patients 6 years and older presenting with minor strains, sprains, and contusions received FLECTOR twice a day for as many as 16 days. The most commonly reported adverse events (incidence ≥ 2%) were headache (9%), application site pruritus (7%), nausea (3%), and dyspepsia (3%). No adverse events led to discontinuation of treatment.

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