Label Changes for:

Alesse 28 Tablets (levonorgestrel and ethinyl estradiol tablets)

January 2008

Changes have been made to the CONTRAINDICATIONS, WARNINGS 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

CONTRAINDICATIONS

WARNINGS

  • Thromboembolic Disorders and Other Vascular Problems
  • Figure II: Circulatory Disease Mortality Rates Per 100,000 Woman Years By Age, Smoking Status and Oral-Contraceptive Use
  • Venous Thrombosis and Thromboembolism
  • Carcinoma of the Reproductive Organs and Breasts

PATIENT PACKAGE INSERT:DETAILED PATIENT LABELING

  • Who Should Not Take Oral Contraceptives
  • Risks of Taking Oral Contraceptives
    • Risk of Developing Blood Clots
    • Lipid Metabolism and Pancreatitis

CONTRAINDICATIONS

  • Valvular heart disease with thrombogenic complications

WARNINGS

Venous Thrombosis and Thromboembolism

...Since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than four weeks after delivery in women who elect not to breast-feed or after a midtrimester pregnancy termination.

Carcinoma of the Reproductive Organs and Breasts

See highlighted text for labeling revisions.

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