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Thyroid USP

Is Thyroid USP FDA-Approved?

Thyroid USP has never received approval from the U.S. Food and Drug Administration (FDA). Many Web sites imply that the drug is an FDA-approved product, but this is simply not the case.
However, this is not necessarily as bad as it sounds. Many prescription medications have never received FDA approval. Almost always, these are old medications that were in use long before the FDA existed or before certain laws and regulations were in place. For instance, phenobarbital (Luminal®), a prescription seizure medication, has never received FDA approval.
Synthetic thyroid replacement medications (such as levothyroxine) were also unapproved until recently. The FDA required each of these medications to perform the necessary studies and seek approval.
The FDA may require natural thyroid products to do the same in the future. Until then, the lack of FDA approval for thyroid USP may be a cause for concern. For instance, the prescribing information for thyroid USP does not meet the usual FDA standards, since it does not list the possible side effects, except for a few listed with the warnings and precautions.

When and How to Take Thyroid USP

General considerations for when and how to take thyroid USP include the following:
  • The medication comes in tablet form and is usually taken once a day.
  • Although the prescribing information for thyroid USP does not mention this, it is best to take the drug on an empty stomach, 30 to 60 minutes before a meal.
  • Since the tablets contain ground-up pig thyroids, they have a characteristic odor that many people consider unpleasant.
  • Your healthcare provider will adjust your thyroid USP dose based on certain blood tests. Be sure to tell him or her if you have missed any of your doses, as this may affect any adjustments.
  • Try to take thyroid USP at the same time each day to keep an even level in your blood.
  • For the medication to work properly, it must be taken as prescribed. Thyroid USP will not work if you stop taking it.
Last reviewed by: Kristi Monson, PharmD
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