Medication Errors Associated with Levothyroxine Products

Abstract

The FDA Office of Postmarketing Drug Risk Assessment conducted a review of medication errors that have been reported with levothyroxine. These cases were obtained from the FDA Adverse Event Reporting System (AERS) database as well as the published medical literature. A total of 18 reports of medication errors were obtained from these sources. Ten reports involved the dispensing of the incorrect drug. Four of these reports had a serious outcome. Six of the ten reports involved confusion between Lanoxin (digoxin) and levothyroxine. Eight other reports involved dispensing of the incorrect dose of levothyroxine. Three of these reports of dosing errors had a serious outcome, including one death. Based upon these data and general principles of patient counseling, recommendations were made to help prevent additional medication errors amd to promote patient understanding of their medications and medical conditions.