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.
