Monday, June 14, 2021

Older Therapies Aren’t Necessarily Better for Thyroid Hormone Replacement - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

Older Therapies Aren't Necessarily Better for Thyroid Hormone Replacement

Millions of people have thyroid glands that don't make enough thyroid hormone to meet their body's needs. Hypothyroidism, also called underactive thyroid, is the most common reason some people need thyroid hormone replacement.

Hypothyroidism is treated by replacing the hormones that your own thyroid can no longer make. Thyroid hormone medicines mimic these hormones.

Thyroid hormone has been used as medicine for decades. The first versions of thyroid hormone medicines were made from the thyroid glands of pigs or cows and are not approved by the U.S. Food and Drug Administration. Today, there are modern, synthetic (laboratory-made) medications approved by the FDA. Most patients with hypothyroidism use these modern thyroid replacement drugs.

Some people still use unapproved products made from animal sources. The FDA has been encouraging manufacturers of unapproved medicines to apply for FDA approval, as required by law. This is in patients' interest. The FDA's drug approval process helps ensure that medications are safe and effective for their intended use. Unapproved medicines pose risks because the FDA has not reviewed them for safety, effectiveness, or quality before they are sold to patients.

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