Label Changes for:

Ampyra (dalfampridine)

January 2013

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

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

 

January 2013

5 WARNINGS AND PRECAUTIONS

5.4 Anaphylaxis
  • AMPYRA can cause anaphylaxis and severe allergic reactions. Signs and symptoms have included respiratory compromise, urticaria, and angioedema of the throat and or tongue. Patients should be informed of the signs and symptoms of anaphylaxis and instructed to discontinue AMPYRA and seek immediate medical care should these signs and symptoms occur (17.3)

17 PATIENT COUNSELING INFORMATION

17.3 Anaphylaxis
  • Advise patients to discontinue AMPYRA and seek medical care if they develop signs and symptoms of anaphylaxis.
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