OBJECTIVE: Thyroid hormone extract is used for the treatment of @entity1374 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 @entity1 treated for @entity1374 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 FDA's reported adverse events for @entity1955 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 @entity1 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 TSH. A majority of TSH changes and symptoms described were consistent with @entity2743 (65%), 2 cases had developed @entity943 . Reporters noted difficulty in dose adjustment by primary care providers due to @entity911 in interpreting thyroid function test results while on thyroid extract which often necessitated subspecialty referrals. CONCLUSIONS: These adverse event reports should stimulate consideration by FDA to regulate and monitoring of thyroid hormone extract use and consider standardizing these extracts to meet current standards of manufacture, hormone content, availability and shelf-life like the rigor to which preparations like @entity1955 are monitored.

ADVERSE EVENT REPORTING IN XXXX TREATED WITH THYROID HORMONE EXTRACT.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity2743 :: ('MESH:D006111', 'Disease') :: ['thyrotoxicosis'] @entity1955 :: ('MESH:D013974', 'Chemical') :: ['levothyroxine', 'Levothyroxine'] @entity911 :: ('MESH:D003221', 'Disease') :: ['confusion'] @entity943 :: ('MESH:D001145', 'Disease') :: ['arrhythmias'] @entity1374 :: ('MESH:D013959', 'Disease') :: ['thyroid disease', 'thyroid disorders']
@entity1 :: (9606,Species) :: ['PATIENTS']
