Drug Information for Prempro (Physicians Total Care, Inc.): 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 (5.1)]
    • Breast Cancer [see Boxed Warning, Warnings and Precautions, Malignant Neoplasms (5.2)]
    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 1-year clinical trial that included 678 postmenopausal women treated with PREMPRO and 351 postmenopausal women treated with PREMPHASE, the following adverse events occurred at a rate greater than or equal to 5 percent, see Table 1.

    TABLE 1: ALL TREATMENT EMERGENT STUDY EVENTS REGARDLESS OF DRUG RELATIONSHIP REPORTED AT A FREQUENCY GREATER THAN OR EQUAL TO 5%
    PREMPROPREMPROPREMPHASE
    Body System0.625 mg/2.5 mg continuous 0.625 mg/5 mg continuous 0.625 mg/5 mg sequential
    Adverse event (n = 340) (n = 338) (n = 351)
    Body As A Whole
    abdominal pain 16% 21% 23%
    accidental injury 5% 4% 5%
    asthenia 6% 8% 10%
    back pain 14% 13% 16%
    flu syndrome 10% 13% 12%
    headache 36% 28% 37%
    infection 16% 16% 18%
    pain 11% 13% 12%
    pelvic pain 4% 5% 5%
    Digestive System
    diarrhea 6% 6% 5%
    dyspepsia 6% 6% 5%
    flatulence 8% 9% 8%
    nausea 11% 9% 11%
    Metabolic and Nutritional
    peripheraledema 4% 4% 3%
    Musculoskeletal System
    arthralgia 9% 7% 9%
    leg cramps 3% 4% 5%
    Nervous System
    depression 6% 11% 11%
    dizziness 5% 3% 4%
    hypertonia 4% 3% 3%
    Respiratory System
    pharyngitis 11% 11% 13%
    rhinitis 8% 6% 8%
    sinusitis 8% 7% 7%
    Skin and Appendages
    pruritus 10% 8% 5%
    rash 4% 6% 4%
    Urogenital System
    breast pain 33% 38% 32%
    cervix disorder 4% 4% 5%
    dysmenorrhea 8% 5% 13%
    leukorrhea 6% 5% 9%
    vaginal hemorrhage 2% 1% 3%
    vaginitis 7% 7% 5%

    During the first year of a 2-year clinical trial with postmenopausal women between 40 and 65 years of age (88% Caucasian), 989 postmenopausal women received continuous regimens of PREMPRO, and 332 received placebo tablets. Table 2 summarizes adverse events that occurred at a rate greater than or equal to 5 percent in at least 1 treatment group.

    TABLE 2: PERCENT OF PATIENTS WITH TREATMENT EMERGENT STUDY EVENTS REGARDLESS OF DRUG RELATIONSHIP REPORTED AT A FREQUENCY GREATER THAN OR EQUAL TO 5% DURING STUDY YEAR 1
    Body SystemPrempro0.625 mg/2.5 mgcontinuous Prempro0.45 mg/1.5 mgcontinuous Prempro0.3 mg/1.5 mgcontinuous Placebodaily
    Adverse event(n = 331)(n = 331)(n = 327)(n = 332)
    Any adverse event 92% 89%90%85%
    Body As A Whole
    abdominal pain17% 16% 13% 11%
    accidentalinjury 10% 9% 9% 9%
    asthenia 8%8%6%5%
    back pain12%13%12%12%
    flu syndrome8%11%10%11%
    headache28%29%33%28%
    infection21%19%18%22%
    pain14%15%20%18%
    Digestive System
    diarrhea7%7%6%6%
    dyspepsia8%8%8%14%
    flatulence7%8%5%3%
    nausea7%10%8%9%
    Musculoskeletal System
    arthralgia 9%13%10%12%
    leg cramps7%5%4%2%
    myalgia 5%5%4%8%
    Nervous System
    anxiety 4%5%2%4%
    depression 11%5%8%7%
    dizziness 3%5%5%5%
    insomnia 6%7%6%10%
    nervousness 3%2%2%2%
    Respiratory System
    coughincreased8%5%6%4%
    pharyngitis 11%8%9%11%
    rhinitis 8%9%10%13%
    sinusitis 8%8%10%7%
    upper respiratory infection10%9%11%11%
    Skin and Appendages
    pruritus 4%5%5%2%
    Urogenital System
    breast enlargement5%3%2%less than 1%
    breast pain26%21%13%9%
    dysmenorrhea5%6%3%less than 1%
    leukorrhea 4%5%3%3%
    vaginal hemorrhage6%4%2%0%
    vaginal moniliasis8%7%4%2%
    vaginitis 5%6%4%1%
    6.2 Postmarketing Experience

    The following adverse reactions have been reported with PREMPRO or PREMPHASE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

    Genitourinary System

    Abnormal uterine bleeding, dysmenorrhea/pelvic pain, increase in size of uterine leiomyomata, vaginitis, vaginal candidiasis, amenorrhea, changes in cervical secretion, ovarian cancer, endometrial hyperplasia, endometrial cancer.

    Breasts

    Tenderness, enlargement, pain, nipple discharge, galactorrhea, fibrocystic breast changes, breast cancer.

    Cardiovascular

    Deep and superficial venous thrombosis, pulmonary embolism, superficial thrombophlebitis, myocardial infarction, stroke, increase in blood pressure.

    Gastrointestinal

    Nausea, vomiting, abdominal pain, bloating, cholestatic jaundice, increased incidence of gallbladder disease, pancreatitis, changes in appetite, ischemic colitis.

    Skin

    Chloasma or melasma that may persist when drug is discontinued, erythema multiforme, erythema nodosum, loss of scalp hair, hirsutism, pruritus, urticaria, rash, acne.

    Eyes

    Retinal vascular thrombosis, intolerance of contact lenses.

    Central Nervous System (CNS)

    Headache, migraine, dizziness, mental depression, exacerbation of chorea, mood disturbances, anxiety, irritability, exacerbation of epilepsy, dementia, growth potentiation of benign meningioma.

    Miscellaneous

    Increase or decrease in weight, arthralgia, glucose intolerance, edema, changes in libido, angioedema, anaphylactoid/anaphylactic reactions, exacerbation of asthma, increased triglycerides, hypersensitivity.

    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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