Información de la droga para GELNIQUE (oxybutynin chloride) 10% gel (Watson Pharmaceuticals, Inc.): ADVERSE REACTIONS

  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.

  • 6.1 Clinical Studies Experience

  • The safety of GELNIQUE was evaluated in 789 patients (389 randomized to GELNIQUE 1 g and 400 randomized to placebo) during a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study. A subset of these 789 patients (N=216) participated in the 14-week open-label safety extension that followed the placebo-controlled study. Of 216 patients in the safety extension, 107 were randomized to placebo gel during the double-blind, placebo-controlled 12-week study. In the combined double-blind, placebo-controlled study and the open-label safety extension, a total of 496 patients were exposed to at least one dose of GELNIQUE. Four hundred thirty-one (431) patients received at least 12 weeks of GELNIQUE treatment and 85 patients received 26 weeks of GELNIQUE treatment. The study population primarily consisted of Caucasian women (approximately 90%) with an average age of 59 years who had overactive bladder with urge urinary incontinence.

    Table 1 lists adverse events, regardless of causality, that were reported in the randomized, double-blind, placebo-controlled 12-week study at an incidence greater than placebo and in greater than 2% of patients treated with GELNIQUE.

    Table 1: Common Adverse Events in the Randomized, Double-blind, Placebo-controlled 12-Week Study (>2% and > placebo)
    Adverse EventGELNIQUE 1 gramN=389n (%)PlaceboN=400n (%)
    * Includes application site pruritus, dermatitis, papules, anesthesia, erythema, irritation, pain and papules
    Dry mouth29 (7.5)11 (2.8)
    Urinary tract infection27 (6.9)17 (4.3)
    Application site reactions*21 (5.4)4 (1.0)
    Upper respiratory tract infection21 (5.4)20 (5.0)
    Dizziness11 (2.8)4 (1.0)
    Nasopharyngitis11 (2.8)9 (2.3)
    Fatigue8 (2.1)4 (1.0)
    Gastroenteritis viral8 (2.1)7 (1.8)

    The most common adverse reactions, defined as adverse events judged by the investigator to be reasonably associated with the use of study drug, that were reported in ≥ 1% of GELNIQUE-treated patients were dry mouth (6.9%), application site reactions (5.4%), dizziness (1.5%), headache (1.5%), constipation (1.3%), and pruritus (1.3%). Application site pruritus (2.1%) and application site dermatitis (1.8%) were the most commonly reported application site reactions. A majority of treatment-related adverse events were described as mild or moderate in intensity, except for two patients reporting severe headache.

    No serious adverse events were judged by the investigator to be treatment-related during the randomized, double-blind, placebo-controlled 12-week study. The most common adverse reaction leading to drug discontinuation was application site reaction (0.8% with GELNIQUE versus 0.3% with placebo).

    The most common adverse reactions reported during the 14-week open-label extension study were application site reactions (6.0%) and dry mouth (1.9%). The most common reason for premature discontinuation was application site reactions (9 patients or 4.2%). Two of these 9 patients experienced application site reactions of severe intensity (dermatitis, urticaria, and erythema).

  • Drug Information Provided by National Library of Medicine (NLM).