Amerithroid - Important Safety Information

Note that DTE products, including Amerithroid®, have not been reviewed by the FDA for safety or efficacy.

Important Safety Information

WARNING: NOT FOR THE TREATMENT OF OBESITY OR FOR WEIGHT LOSS

Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, especially when taken with certain other medicines used to reduce appetite.

• Do not use Amerithroid® (Thyroid Tablets, USP) if you have uncorrected lack of adrenal hormones, excess of thyroid hormones, or apparent allergies to any of the active or inactive ingredients of Amerithroid.
• Use Amerithroid only as ordered by your doctor. Taking too much or too little Amerithroid may lead to negative effects on growth and development, heart function, bone health, reproductive function, mental health, and digestive function, as well as changes in blood sugar and cholesterol metabolism, in adult or pediatric patients.
• Taking too much Amerithroid may affect your heart, especially if you are elderly or have heart disease. Tell your doctor immediately if you have any signs of increased heart rate, chest pain, or an irregular heartbeat.
• Tell your doctor about any other medical conditions you may have, especially diabetes mellitus, diabetes insipidus, and adrenal gland problems. The dose of other drugs you may be taking to control these conditions may have to be changed while you are taking Amerithroid. If you have diabetes, check your blood sugar levels and/or the glucose in your urine, as ordered by your doctor, and immediately tell your doctor if there are any changes.
• If you are taking blood thinners, your blood clotting status should be checked often.
• In infants, excessive doses of Amerithroid may produce a condition called craniosynostosis (premature closure of the head bones).
• Partial hair loss may be experienced by children during the first few months of taking Amerithroid.
• Tell your doctor if you are taking any other drugs, including prescription and over-the-counter products.
• Once your doctor has found your specific Amerithroid dose, it is important to have periodic lab tests and clinical evaluations to assess your treatment response.

This is the most important safety information you should know about Amerithroid. For more information, talk with your doctor.

Indications

Amerithroid® (Thyroid Tablets, USP) for oral use is a prescription of thyroid hormones (T3 and T4) obtained from pig thyroid.

Amerithroid is used to treat a condition called hypothyroidism of any cause in patients of any age (children, adults, the elderly). It is meant to replace the thyroid hormones made by your thyroid gland. Generally, thyroid replacement treatment is to be taken for life.

Amerithroid is also used to suppress a hormone called thyroid-stimulating hormone (TSH) in the treatment or prevention of various types of thyroid growths, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto's), and multinodular goiter, as well as in the management of thyroid cancer.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information, including Boxed Warning.