Synthroid: What You Should Know - Brief Article

Healthfacts, Oct, 2001 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.

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