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FOOD AND DRUG ADMINISTRATION - page 130 / 263

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specialize in the care of patients with endocrine and metabolic disorders.  We're the specialists that are most often called upon by our colleagues for the care of patients with thyroid and other glandular diseases and hence we have an acute awareness of the effects of thyroid replacement medication.

We are well aware that minor changes in thyroid hormone levels in the bloodstream can result in significant symptoms on the part of our patients.  When there is excessive amount of thyroid hormone in the blood, hyperthyroidism can produce a number of symptoms, including changes in the heart rhythm, accelerated osteoporosis, muscle weakness and weight loss, psychiatric symptoms and others.

When the thyroid hormone level in the blood is insufficient and hypothyroidism results, premature ischemic heart disease can occur, high cholesterol levels, abnormal weight gain, menstrual changes, fatigue, lethargy, and other symptoms are rather common.

Dosage changes of as little as 12.5 to 25 micrograms of oral thyroxine daily can, indeed, have significant effects on serum TSH and on the symptoms that

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