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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: What You Should Know - Brief Article
From Healthfacts, 10/1/01 by Arthur A. Levin

This past summer there were media reports that the Food and Drug Administration (FDA) might require the withdrawal of Synthroid the most popular thyroid medicine sold in the U.S and the third most frequently prescribed drug. Many people who take Synthroid were understandably alarmed about the drug's safety. Thyroid hormone was first introduced to the U.S. market prior to 1938, an era when drug companies did not have to prove their products were safe or effective.

Several years ago, the FDA became aware of adverse events involving potency problems with Synthroid and other products in its drug class (known as levothyroxine sodium). The reported problems included lack of stability, lack of potency, failure to maintain potency through the expiration date, and variation in the amount of active ingredient in the same branded product depending on the date of manufacture.

By 1997, the growing number of reports of significant variation in potency eventually moved the FDA to order all manufacturers of levothyroxine sodium thyroid products to submit proof of their product's safety and effectiveness within three years. Synthroid's manufacturer, Abbott Labs, has not yet complied and, consequently, has been ordered by the FDA to begin to progressively reduce Synthroid production until it is completely halted in August 2003.

People taking Synthroid should ask their doctor about switching to either Unithriod or Levoxyl, two brands deemed safe and effective by the FDA.

--

Arthur A. Levin, MPH, is the director of the Center for Medical Consumers in New York City.

COPYRIGHT 2001 Center for Medical Consumers, Inc.
COPYRIGHT 2001 Gale Group

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