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U.S. Department of Health and Human Services

Safety

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Accutane (isotretinoin capsules)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- November 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. Read about the new physician labeling format.


 

Summary View

 

Sections Modified

MEDICATION GUIDE

  • What is the most important information I should know about Accutane?

    ...If you get pregnant while taking Accutane, stop taking it right away and call your doctor. Doctors and patients should report all cases of pregnancy to:

    • FDA MedWatch at 1-800-FDA-1088, and (added)
    • the iPLEDGE pregnancy registry at 1-866-495-0654