药物信息为Vagifem (estradiol vaginal tablets) Initial U.S. Approval: 1999 (Novo Nordisk): 6 ADVERSE REACTIONS

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  • The following serious adverse reactions are discussed elsewhere in the labeling:

    • Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.2)]
    • Endometrial Cancer [see Boxed Warning, Warnings and Precautions (5.3)]
  • 6.1 Clinical Study Experience

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

    In a 12-month randomized, double-blind, parallel group, placebo-controlled study, a total of 309 postmenopausal women were randomized to receive either placebo or Vagifem 10 mcg tablets. Adverse events with an incidence of =5% in the Vagifem 10 mcg group and greater than those reported in the placebo group are listed in Table 1.

    Table 1: Treatment-Emergent Adverse Events Reported at a Frequency of =5% and More Frequent in Women Receiving Vagifem 10 mcg

    Body System

    Adverse Event

    Treatment

    Number (%) of Women

    Placebo

    N = 103

    n (%)

    Vagifem

    N = 205

    n (%)

    Body As A Whole
    Back Pain2 (2)14(7)
    Digestive System
    Diarrhea011 (5)
    Urogenital System
    Vulvovaginal Mycotic Infection3 (3)17 (8)
    Vulvovaginal Pruritis 2 (2)16 (8)
    N = Total number of women in study.

    n = Number of women who experienced adverse event.

    In a 12-week, randomized, double-blind, placebo-controlled study, 138 postmenopausal women were randomized to receive either placebo or Vagifem 25 mcg tablets. Adverse events with an incidence of =5% in the Vagifem 25 mcg group and greater than those reported in the placebo group are listed in Table 2.

    Table 2: Treatment-Emergent Adverse Events Reported at a Frequency of =5% and More Frequent in Women Receiving Vagifem 25 mcg

    Body System

    Adverse Event

    Treatment

    Number (%) of Women

    Placebo

    N = 47

    n (%)

    Vagifem

    N = 91

    n (%)

    Body As A Whole
    Headache 3 (6)8 (9)
    Abdominal Pain2 (4)6 (7)
    Back Pain3 (6)6 (7)
    Respiratory System

    Upper Respiratory Tract

    Infection

    2 (4)5 (5)
    Urogenital System
    Moniliasis Genital1 (2)5 (5)
    N = Total number of women in study.

    n = Number of women who experienced adverse event.

  • 6.2 Postmarketing Experience

  • The following adverse reactions have been reported during post approval use of Vagifem 25 mcg. 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.

    Genitourinary System

    Endometrial cancer, endometrial hyperplasia, vaginal irritation, vaginal pain, vaginismus, vaginal ulceration

    Breast

    Breast cancer

    Cardiovascular

    Deep vein thrombosis

    Gastrointestinal

    Diarrhea

    Skin

    Urticaria, erythematous/pruritic rash, genital pruritus

    Central Nervous System

    Aggravated migraine, depression, insomnia

    Miscellaneous

    Fluid retention, weight increase, drug ineffectiveness, hypersensitivity, blood estrogen increase

    Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy.

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