NP Thyroid Market Status
There is no current evidence of new laws or regulations that will remove NP Thyroid (desiccated thyroid extract) from the market. However, it's important to understand that desiccated thyroid extract products like NP Thyroid operate outside formal FDA oversight for potency and consistency, with manufacturers self-monitoring T4 and T3 content 1.
Current Regulatory Status
Desiccated thyroid extract (DTE) products remain available but lack the same regulatory oversight as synthetic levothyroxine, which underwent formal FDA approval processes in 2000 1.
Manufacturers of DTE products, including NP Thyroid, are responsible for monitoring consistency of T4 and T3 contents themselves, without the same level of FDA scrutiny applied to synthetic thyroid hormone preparations 1.
Clinical Practice Recommendations
Levothyroxine (LT4) monotherapy should remain the treatment of choice for newly diagnosed hypothyroid patients, as this is the standard recommendation supported by clinical guidelines 2.
When DTE Might Be Considered
For patients who have unambiguously not benefited from LT4 monotherapy, a trial of combination therapy can be considered 1.
DTE provides a fixed LT4/LT3 ratio of approximately 4:1, with the mean daily dose needed to normalize TSH containing approximately 11 mcg of T3, though some patients may require higher doses 1.
Important Caveats About DTE Products
The lack of formal FDA oversight means there may be batch-to-batch variability in hormone content, which could affect clinical outcomes and TSH stability 1.
Patients on DTE should be monitored carefully for signs of overtreatment or undertreatment, as the fixed ratio may not be optimal for all individuals 1.
Bioequivalence can differ among generics and brand names of thyroid preparations, which is a concern that applies to both synthetic and natural thyroid products 3.