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December 1, 2000
FDA Warns Consumers About Thyroid Hormone Supplement
WASHINGTON--The Food and Drug Administration (FDA) on Nov. 21 issued aconsumer warning about products marketed as dietary supplements that contain athyroid hormone known as tiratricol. It warned that the tiratricol product cancause serious health concerns including heart attack and stroke. FDA originallyissued a warning on the product in November 1999, targeting Syntrax Innovationsin Cape Giradeau, Mo., for its sale of Triac.
According to information from Syntrax's Web site, Triac is a "naturallyoccurring degradation product" of the thyroid hormone T3 (levo-Triiodothyronine)and has been sold as a fat loss drug in many countries around the world. Aconsumer service rep from Syntrax could not comment on the product or FDA'sactions, except to note that it no longer sells Triac.
Despite three product recalls in April 2000, and another one in September2000 from four different manufacturers, FDA said it believed that productscontaining tiratricol may have reached consumers. When contacted at press time,FDA had no information regarding the number or type of adverse events associatedwith tiratricol that had been reported to FDA; an agency spokesperson noted thatany number of events is considered cause for action. FDA is urging consumers toconsult their health care provider if they have been taking the product and areexperiencing any adverse effects, which may include insomnia, sweating anddiarrhea.
John Hathcock, director of scientific affairs with the Council forResponsible Nutrition, noted that CRN was monitoring the situation to ensurethat FDA was working through the proper regulatory channels and using reasonablesafety standards for the recall. However, he added, he was not aware of any CRNmembers selling the product, and thought it was really a rather minor product inthe overall marketplace.
For more information, visit www.fda.gov.
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