thyroid meds.

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WASHINGTON, DC -- August 23, 2000 -- The FDA has approved the first NDA for the

thyroid hormone replacement drug, levothyroxine sodium (Unithroid), for use in

adults and children.

In children, thyroid hormones are essential for normal physical growth and

intellectual development. They are also involved in the regulation of a wide

range of metabolic processes within the body in all age groups.

Hypothyroidism, or low levels of thyroid hormone, may be due to a birth defect

(e.g. partial or complete absence of the thyroid gland) or it may occur later in

life due, for example, to thyroiditis, goiter, or surgical removal of the

thyroid gland.

Symptoms of hypothyroidism include poor growth in children and, in those born

with this disorder, impaired intellectual development if this disorder is not

promptly and adequately treated. Symptoms of hypothyroidism in children and

adults include fatigue, cold intolerance, dry skin, lethargy and weight gain.

Levothyroxine is identical to a natural thyroid hormone produced by the body and

is most commonly used to return thyroid hormone levels to normal in patients

with hypothyroidism. The dose of levothyroxine for replacement or supplemental

therapy in patients with hypothyroidism must be individualized based on patient

response. Patients taking levothyroxine as replacement must be monitored with

blood tests at regular intervals to determine that thyroid hormone levels are

within the normal range, to assure patient safety, and to help guide dose

adjustments.

During initiation of replacement therapy with levothyroxine, blood tests are

usually performed every six to eight weeks in adults to aid in dose adjustment.

Once the optimal replacement dose of levothryoxine for an individual adult

patient is determined, blood tests are usually done less frequently; e.g., every

six to twelve months. Infants and children are usually begun on full

levothyroxine replacement doses and the frequency of monitoring of blood tests,

growth and intellectual development is age-dependent.