ADVERSE REACTIONS
In controlled trials during the premarketing development of Flector® Patch, approximately 600 patients with minor sprains, strains, and contusions have been treated with Flector® Patch for up to two weeks.
Adverse Events Leading to Discontinuation of Treatment
In the controlled trials, 3% of patients in both the Flector® Patch and placebo patch 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® Patch and placebo patch groups. Application site reactions leading to dropout included pruritus, dermatitis, and burning.
Common Adverse Events
Localized Reactions
Overall, the most common adverse events associated with Flector® Patch 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® Patch. A majority of patients treated with Flector® Patch 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® Patch or Placebo Patch1 | Diclofenac N=572 | Placebo N=564 |
| N | Percent | N | Percent |
| 1 The table lists adverse events occurring in placebo-treated patients because the placebo-patch was comprised of the same ingredients as Flector® Patch except for diclofenac. Adverse events in the placebo group may therefore reflect effects of the non-active ingredients. |
| 2 Includes: application site dryness, irritation, erythema, atrophy, discoloration, hyperhidriosis, and vesicles. |
| 3 Includes: gastritis, vomiting, diarrhea, constipation, upper abdominal pain, and dry mouth. |
| 4 Includes: hypoaesthesia, 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 |
| Other2 | 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 |
| Other3 | 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 |
| Other4 | 4 | 1 | 3 | < 1 |
Foreign labeling describes that dermal allergic reactions may occur with Flector® Patch treatment. Additionally, the treated area may become irritated or develop itching, erythema, edema, vesicles, or abnormal sensation.
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