Label Changes for:

Enablex (darifenacin) extended-release tablets

October 2010

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2010

 

WARNINGS

  • Angioedema of the face, lips, tongue, and/or larynx have been reported with darifenacin. In some cases angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, darifenacin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

PRECAUTIONS

Information for Patients
  • Patients should be informed that darifenacin may produce clinically significant angioedema that may result in airway obstruction.

ADVERSE REACTIONS

Post-Marketing Surveillance
  • General: ...angioedema with airway obstruction

PATIENT PACKAGE INSERT

What are the possible side effects of ENABLEX?
  • Swelling (angioedema) of the face, lips, tongue, and/or throat may occur. Stop taking Enablex and seek medical attention immediately if you experience swelling of the tongue or throat, or if you experience difficulty breathing.
Hide
(web5)