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Media Advisory |
WHAT: Workshop addressing safety issues surrounding a commonly used thyroid drug
Three endocrinology specialty organizations are holding a workshop with the FDA — “Joint Public Meeting on Equivalence of Levothyroxine Sodium Products” — to address safety issues for the thyroid drug levothyroxine, used for the treatment of hypothyroidism, or an underactive thyroid.
WHO: American Thyroid Association (ATA), The Endocrine Society (TES), and the American Association of Clinical Endocrinologists (AACE) with the Food and Drug Administration (FDA)
WHEN: Monday, May 23, 2005, 8:30 a.m. – 5:00 p.m.
WHERE: National Transportation Safety Board Boardroom and Conference Center
490 L’Enfant Plaza, SW, Washington, DC
CONTACTS: Melanie Caudron, ATA, melanie.caudron@verizon.net; Tadu Yimam, TES, media@endo-society.org; Sarah Bradley, AACE, sbradley@aace.com.
BACKGROUND:
In June 2004, the FDA approved generic levothyroxine preparations as equivalent to branded products. This FDA decision deemed these generic drugs as having the same clinical effect and safety profile as branded products, which allows a pharmacist to substitute one drug for the other without physician approval or knowledge.
The ATA, TES, and AACE expressed concern over the FDA’s action and initiated an ongoing dialogue to encourage review of the decision — one that was made without significant input from clinical endocrinologists, the recognized experts who care for thyroid patients. The Lawson Wilkins Pediatric Endocrine Society has also joined the other three societies in their advocacy before the FDA.
Levothyroxine is a drug recognized to have a narrow toxic-to-therapeutic ratio, which can result in significant clinical consequences when the change of preparations results in excessive or inadequate treatment. Some of the potential adverse events include the recurrence of symptoms, osteoporosis, atrial fibrillation, worsening of ischemic heart disease, preterm delivery in pregnancy, and high cholesterol.
Insurance companies and pharmacy benefit managers were quick to apply the new FDA policy, which has resulted in many patients receiving a different preparation of levothyroxine, often without their or their doctors’ knowledge. Many who have tried to continue using the formulation prescribed by their doctors have run into numerous barriers — financial and administrative.
Every time a patient is switched to a different preparation, they need to have a new thyroid function test — an added cost and hassle — which evaluates if the dose of the new preparation is achieving the therapeutic target. If not, the dose must be adjusted. Moreover, this repeat testing often does not happen because of unawareness of the change.
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