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U.S. Department of Health and Human Services

Safety

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Lovaza (omega-3-acid ethyl esters) Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009

 

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

 

Brand (Generic) Name

Sections Modified

Lovaza (omega-3-acid ethyl esters) Capsules

ADVERSE REACTIONS

  • Postmarketing Experience
    • The following events have been reported: anaphylactic reaction, hemorrhagic diathesis