Label Changes for:

Frova (frovatriptan succinate) Tablets 2.5 mg

March 2009

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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


Summary View

Sections Modified

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

  • Postmarketing Experience
    • reports of seizure in close temporal association with triptan use

PATIENT PACKAGE INSERT

  • information concerning serotonin syndrome with concomitant use of triptans and SSRIs/SNRIs

WARNINGS AND PRECAUTIONS

  • Includes information concerning serotonin syndrome with concomitant use of triptans and SSRIs/SNRIs
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