Label Changes for:

EstroGel 0.06% (estradiol gel)

January 2008

Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

BOXED WARNING

  • Cardiovascular and Other Risks

WARNINGS

  • Cardiovascular Disorders
    • Stroke
    • Coronary Heart Disease
    • Venous Thromboembolism (VTE)
  • Malignant Neoplasms
    • Endometrial Cancer
    • Breast Cancer
    • Ovarian Cancer
  • Dementia

PRECAUTIONS

  • General
    • Hypertriglyceridemia
    • Alcohol-based Gels are Flammable
  • Laboratory Tests
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Pregnancy
  • Nursing Mothers
  • Pediatric Use
  • Geriatric Use

ADVERSE REACTIONS

  • Genitourinary System
    • Uterine Bleeding/Spotting
    • Pelvic Pain
  • Central Nervous System
    • Exacerbation of Chorea
  • Miscellaneous
    • Glucose Intolerance
    • Hypocalcemia (preexisting condition)

PATIENT PACKAGE INSERT

  • Initial Paragraph
  • What is the most important information I should know about EstroGel (an estrogen hormone)?
  • How is EstroGel used?
  • Tell your healthcare provider...
  • How should I use EstroGel?
  • What should I avoid while using EstroGel?
  • What are the possible side effects of estrogens?
  • What can I do to lower my chances of having an adverse event with EstroGel?
  • What are the ingredients in EstroGel?

BOXED WARNING

Cardiovascular and Other Risks

Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia...

The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE 0.625 mg alone and during 4 years of treatment with daily CE 0.625 mg combined with MPA 2.5 mg, relative to placebo...

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins...

WARNINGS

See highlighted text for labeling revisions.

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