ADVERSE EVENT REPORTING IN PATIENTS TREATED WITH THYROID HORMONE EXTRACT.

OBJECTIVE: Thyroid hormone extract is used for the treatment of thyroid disorders, but limited data exist on adverse events commonly noted by the physicians associated with this use. The purpose of this survey was to report adverse events observed by expert physicians managing patients treated for thyroid disease with thyroid hormones.

METHODS: Members of the American Thyroid Association, The Endocrine Society, and the American Association of Clinical Endocrinologists developed a survey instrument modeled on the U.S. Food and Drug Administration (FDA)'s reported adverse events for levothyroxine that would effectively assess the clinical experience of frequent prescribers of thyroid hormone. Survey links were emailed to physicians, and the websites of each society provided links to the data collection form.

RESULTS: A total of 174 reports of adverse events occurring in patients on thyroid hormone extract were received. Ninety-one of these reports were accompanied by alterations in thyrotropin values and were further analyzed. Of these, 62 (68%) subjects had developed new symptoms associated with altered thyroid-stimulating hormone (TSH). A majority of TSH changes and symptoms described were consistent with thyrotoxicosis (65%), and 2 patients had developed arrhythmias. Reporters noted difficulty in dose adjustment by primary care providers due to confusion in interpreting thyroid function test results while on thyroid extract, which often necessitated subspecialty referrals.

CONCLUSION: These adverse event reports should stimulate consideration by the FDA to regulate and monitor thyroid hormone extract use and consider standardizing these extracts to meet current standards of manufacture, hormone content, availability, and shelf-life, like the rigor with which preparations such as levothyroxine are monitored.

ABBREVIATIONS: AE = adverse event ATA = American Thyroid Association FDA = Food and Drug Administration LT3 = liothyronine LT4 = levothyroxine PTF = Pharmacovigilance Task Force T3 = triiodothyronine TSH = thyroid-stimulating hormone.