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Synthroid

Synthroid is the brand name used by Abbott Laboratories for levothyroxine sodium (T4, a synthetic thyroid hormone) product. Levothyroxine is the basic T4 thyroid hormone responsible for metabolism. Patients who suffer from hypothyroidism, either for endogenous disease or after radioactive iodine ablation or thyroid resection, require exogenous thyroid hormone, and Synthroid is the most prescribed brand of T4. Synthroid was marketed in 1955, but was not FDA approved at that time as it was considered "generally regarded safe". more...

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In the 1990s, in response to various complaints, all levothyroxine preparations were required to undergo the formal FDA approval process. Synthroid was approved by the FDA on 2002-07-24.

It should be noted that Synthroid was not the first T4 produced for patients, and there are generic versions approved by the Food and Drug Administration, but Synthroid represented a significant advance on other brands and formulations in terms of uniformity of production and regularity of therapeutic action. Therefore, many endocrinologists and other prescribers specify a specific thyroid hormone brand because thyroid hormone has a narrow therapeutic index. In the United States, Synthroid is the most prescribed drug. Despite its frequent use, however, it is far from being a so-called "blockbuster drug" ($1 billion USD or more in sales annually).

Notes

  • ^  Company Report on Abbott
  • ^  Dr Mercola's site
  • ^  FDA approval

Read more at Wikipedia.org


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Synthroid - Shorts - Brief Article
From Townsend Letter for Doctors and Patients, 2/1/02 by Jule Klotter

In July 2001, the Food and Drug Administration considered pulling the thyroid medication Synthroid off the market for safety reasons. The agency was concerned that the pills' potency varies from the amount stated on labels. Instead of receiving an established amount of the synthetic hormone, patients may receive slightly more or less, enough to cause fatigue or heart palpitations. In a few cases, patients have ended up in the hospital. According to a US News & World Report article, 150 pill lots have been recalled by manufacturers since 1991, because of concerns about unreliable dosages.

Makers of Synthroid, Cytomel, Levothroid, Levo-T and other synthetic thyroid drugs have been asked to provide the FDA with documentation about the safety of their manufacturing processes. The agency's review of the data is expected to be finished by 2003. Unithroid and Levoxyl have already been reviewed and have received FDA approval.

"Reports of thyroid drug's demise were exaggerated" by Josh Fischman. US News & World Report, July 30, 2001

COPYRIGHT 2002 The Townsend Letter Group
COPYRIGHT 2002 Gale Group

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