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U.S. Department of Health and Human Services

Safety

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Estraderm (estradiol) transdermal system

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

June 2012 

Summary View

 

BOXED WARNING

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA
Estrogen-Alone Therapy
  • Endometrial Cancer- There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
  • Cardiovascular Disorders and Probable Dementia
  • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.
  • The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo.
  • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
  • In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.
  • Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
 

CONTRAINDICATIONS

  • Known anaphylactic reaction or angioedema to Estraderm.
  • Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
 

WARNINGS

Anaphylactic Reaction and Angioedema
  • Cases of anaphylaxis, which developed anytime during the course of Estraderm treatment and required emergency medical management, have been reported in the postmarketing setting. Skin (hives, pruritis, swollen lips-tongue-face) and either respiratory tract (respiratory compromise) or gastrointestinal tract (abdominal pain, vomiting) involvement has been noted. Angioedema involving the tongue, larynx, face, hands and feet requiring medical intervention has occurred postmarketing in patients using Estraderm. If angioedema involves the tongue, glottis, or larynx, airway obstruction may occur. Patients who develop an anaphylactic reaction with or without angioedema after treatment with Estraderm should not receive Estraderm again.
Hereditary Angioedema
  • Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema.
 

PRECAUTIONS

Pregnancy
  • There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy.