ADVERSE EVENT REPORTING IN PATIENTS TREATED WITH THYROID HORMONE EXTRACT

Area of Science:

• Endocrinology
• Pharmacovigilance
• Thyroidology

Background:

• Thyroid hormone extract is widely used for treating thyroid disorders.
• Limited data exist on adverse events associated with thyroid hormone extract use.
• Physician-reported adverse events (AEs) are crucial for understanding clinical safety profiles.

Purpose of the Study:

• To report adverse events observed by expert physicians managing patients treated with thyroid hormone extract.
• To assess the clinical experience of frequent prescribers of thyroid hormone.
• To identify common adverse events and challenges in managing patients on thyroid hormone therapy.

Main Methods:

• A survey instrument was developed by members of the American Thyroid Association, The Endocrine Society, and the American Association of Clinical Endocrinologists.
• The survey was modeled on FDA-reported adverse events for levothyroxine (LT4).
• Survey links were distributed via email to physicians and society websites for data collection.

Main Results:

• 174 adverse event reports were received for thyroid hormone extract.
• 91 reports with altered thyrotropin (TSH) values were analyzed.
• 62% of these patients developed new symptoms, predominantly consistent with thyrotoxicosis (65%), and 2 developed arrhythmias.

Conclusions:

• Adverse event reports suggest a need for FDA consideration in regulating and monitoring thyroid hormone extract.
• Standardization of thyroid hormone extracts is recommended to meet current manufacturing and content standards.
• Improved monitoring and standardization are needed, similar to levothyroxine preparations.