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.|
|Sections Modified||Summary of Changes to Contraindications and Warnings|
PATIENT PACKAGE INSERT
...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...