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

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