Joint statement on the U.S. Food and Drug Administration's decision regarding bioequivalence of levothyroxine sodium.

@article{2004JointSO,
  title={Joint statement on the U.S. Food and Drug Administration's decision regarding bioequivalence of levothyroxine sodium.},
  author={},
  journal={Thyroid : official journal of the American Thyroid Association},
  year={2004},
  volume={14 7},
  pages={
          486
        }
}
  • Published 2004
  • Medicine, Biology
  • Thyroid : official journal of the American Thyroid Association
On June 24, 2004, the U.S. Food and Drug Administration (FDA) rejected a citizen petition filed in August 2003 regarding bioequivalence of levothyroxine sodium products and approved first-time generic levothyroixine sodium for the treatment of hypothyroidism. The American Thyroid Association (ATA), The Endocrine Society (TES), and the American Association of Clinical Endocrinologists (AACE), representing more than 4,600 clinical endocrinologists, are concerned that the FDA has moved to approve… 
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21 Citations

21 Citations

Citation Type

Citation Type

New questions regarding bioequivalence of levothyroxine preparations: A Clinician's response
  • W. Green
  • Medicine, Biology
    The AAPS Journal
  • 2008
TLDR
Common indications for thyroid hormone administration are listed, distinguishing its use as replacement therapy in hypothyroidism from its use to suppress thyrotropin (TSH) secretion in cases of thyroid cancer, nodules, and goiter.
Generic and brand-name L-thyroxine are not bioequivalent for children with severe congenital hypothyroidism.
TLDR
Synthroid and an AB-rated generic L-T(4) are not bioequivalent for patients with severe hypothyroidism due to CH, probably because of diminished thyroid reserve, and it would seem prudent not to substitute L- T( 4) formulations in patients withsevere CH, particularly in those <3 yr of age.
Levothyroxine Formulations: Pharmacological and Clinical Implications of Generic Substitution
TLDR
Problems that can be encountered when switching between formulations or when original products are reformulated are discussed in this review, including altered efficacy and adverse events, some of which can be caused by excipients.
European Thyroid Association (ETA) and Thyroid Federation International (TFI) Joint Position Statement on the Interchangeability of Levothyroxine Products in EU Countries
TLDR
The current position statement on behalf of both health-care providers and patients summarizes recent events in several European countries and provides a number of recommendations to limit the burden for patients.
Public engagement and the role of the media in post-marketing drug safety: the case of Eltroxin® (levothyroxine) in New Zealand
TLDR
The Eltroxin® controversy is an illustrative case example of the amplification of ADR reporting by patients following increased media attention in the context of a low consumer reporting environment, indicating that drug safety can be enhanced by actively using media sources and by encouraging patient engagement and reporting of ADRs.
The difficult patient: drug interaction and the influence of concomitant diseases on the treatment of hypothyroidism.
  • L. Ward
  • Medicine, Biology
    Arquivos brasileiros de endocrinologia e metabologia
  • 2010
TLDR
The most common causes for frequent-dose adjustment or high-dose requirement, including poor compliance with therapy and inadequate medication are reviewed, and a growing list of drugs and thyroid disruptors that may also affect thyroid hormone metabolism at many levels are mentioned.
Impact of a forced dose-equivalent levothyroxine brand switch on plasma TSH; a cohort study.
TLDR
The results indicate that a dose-equivalent levothyroxine brand switch may necessitate a dose adjustment in a large number of patients, and patients using at least 25 μg Thyrax® daily for one year or longer were 4-5 times more likely to become hyperthyroid after adose equivalent substitution between brands.
American Thyroid Association Guidelines and Statements: Past, Present, and Future.
TLDR
The ATA remains committed to a process of continual improvement of its publications and to meeting stakeholder information needs and has a long history of producing CPGs and Statements with global impact on informing clinical management, education, and research in thyroid diseases.
Generic levothyroxine initiation and substitution among Medicare and Medicaid populations: a new user cohort study
TLDR
Patient demographic factors and health service utilizations are associated with generic levothyroxine initiation and substitution and educational outreach programs targeted to increase generic lev Timothyroxine use and prescription savings should be tailored based on different patient populations.
Comparison between liquid and tablet formulations of levothyroxine in the initial treatment of congenital hypothyroidism.
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References

Levothyroxine a new drug? Since when? How could that be?
  • J. Hennessey
  • Medicine
    Thyroid : official journal of the American Thyroid Association
  • 2003