Label Changes for:
Enablex (darifenacin) Extended-Release Tablets
March 2012
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)
March 2012
WARNINGS AND PRECAUTIONS
Central Nervous System Effects
Enablex is associated with anticholinergic central nervous system (CNS) effects.
- A variety of CNS anticholinergic effects have been reported, including headache, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how Enablex affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.
January 2012
ADVERSE REACTIONS
Postmarketing Experience
General
- anaphylactic reaction
Dermatologic subsection [new]
- erythema multiforme and interstitial granuloma annulare
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.
March 2012
