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U.S. Department of Health and Human Services

Safety

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Emtriva (emtricitabine) Capsules and Oral Solution


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 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 Summary of Changes to Contraindications and Warnings

BOXED WARNING

WARNINGS

  • Patients Co-infected with HIV and Hepatitis B Virus

PATIENT PACKAGE INSERT

  • What is the most important information I should know about Emtriva?
    • If you are also infected with the Hepatitis B Virus (HBV)...
  • What are the possible side effects of Emtriva?
    • "flare-ups" of Hepatitis B Virus infection...

BOXED WARNING

...Emtriva is not approved for the treatment of Chronic Hepatitis B Virus (HBV) Infection...

WARNINGS: Patients Co-infected with HIV and Hepatitis B Virus

...Emtriva is not approved for the treatment of chronic HBV infection...

...In some patients infected with HBV and treated with Emtriva, the exacerbations of hepatitis B were associated with liver decompensation and liver failure...