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Synthroid Has History of Problems, Says FDA

By , About.com Guide

Updated December 13, 2003

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June, 2001 -- Synthroid has a long history of manufacturing problems, subpotency concerns, and stability and reliability issues, says a letter sent to Synthroid's manufacturer from the FDA, and just released to the public.

  • The FDA issued this letter in response to Knoll’s request that Synthroid be permitted to be legally marketed without an approved new drug application and instead be granted what is known as "Generally Recognized as Safe and Effective" status.
  • The history of potency failures…indicates that Synthroid has not been reliably potent and stable.
  • Synthroid’s formulas has been changed numerous times throughout its marketing history.
  • Synthroid has a long history of manufacturing problems.
  • Patients using Synthroid have experienced significant, unintended variations in their doses of levothyroxine sodium…these variations are not conducive to the proper control of hypothyroidism.
More detailed information on problems with Synthroid can be found online in [link url=http://www.thyroid-info.com/articles/synthroidproblems.htm]a detailed chronology and guide.

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