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Axert (almotriptan malate) Tablets 6.25 and 12.5 mg March 2009

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. Read about the new physician labeling format.


Summary View

Sections Modified

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS

  • Serotonin Syndrome

PRECAUTIONS

  • Drug Interactions
    • Selective Serotonin Reuptake Inhibitors/Serotonin Norephinephrine Reuptake Inhibitors and Serotonin Syndrome
  • Information for Patients
    • separate leaflet provided for patients
    • Patients should be cautioned about the risk of serotonin syndrome...

ADVERSE REACTIONS

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

PATIENT PACKAGE INSERT

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

WARNINGS

  • Serotonin Syndrome
    
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