Consultation Response
Division of Medication Errors and Technical Support MEMORANDUM Office of Surveillance and Epidemiology HFD-420; White Oak 22, Room 4447 Center for Drug Evalu ation and Research To: Thomas Laughren, MD Director, Division of Psychiatry Products, HFD-130 Through: Carol Holquist, R.Ph., Director Division of Medication Errors and Technical Support, HFD-420 From: Richard Abate, R.Ph., MS, Safety Evaluator Division of Medication Errors and Technical Support, HFD-420 Date: March 8, 2007 Subject: DMETS MEDICATION ERROR POSTMARKETING SAFETY REVIEW OSE Consult: 2006-879 Cymbalta Duloxetine Hydrochloride Delayed-release Capsules 20 mg, 30 mg, and 60 mg NDA: 21-427 & 21-733 **This document contains proprietary data from the Institute of Safe Medication Practices (ISMP) which cannot be shared outside of the FDA. I. EXECUTIVE SUMMARY During routine post-marketing surveillance of medication errors, DMETS identified a signal involving the opening of Cymbalta capsules prior to administration to achieve a lower dose of the drug. The patient experienced severe nausea and vomiting resulting in an emergency room visit. This prompted DMETS to investigate all medication error cases from the FDA-AERS database, the USP MedMARX database, Institute of Safe Medication Practices outpatient medication errors, and internet discussion groups. In total, cases of medication error were reviewed and classified by the following errors types: wrong strength, wrong technique of opening the capsules, and wrong drug. Significant outcomes associated with these error types include esophageal burning and other GI symptoms, elevated blood pressure, and serotonin syndrome. For each of these error types, we identified contributing factors associated with the container label, carton and insert labeling.
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