Label Changes for:

Exelon Patch (rivastigmine) transdermal system

August 2010

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

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

WARNINGS and PRECAUTIONS

Medication Errors Resulting in Overdose
  • Medication errors with Exelon patches have resulted in serious adverse events; some cases have required hospitalization, and rarely, led to death. The majority of medication errors have involved not removing the old patch when putting on a new one and the use of multiple patches at one time. Patients and caregivers must be given proper instruction on the dosage and administration of Exelon patches.

ADVERSE REACTIONS

Additional Adverse Reactions Reported
  • The following additional adverse reactions have been observed with Exelon capsules/oral solution. Confusion, abnormal liver function tests, duodenal ulcers.
Hide
(web1)