Manufacturer: Abbott Laboratories
Eighty-five percent (85%) of the 8 million people currently using thyroid hormone drugs use Synthroid, the brand name for tablets containing levothyroxine sodium, a synthetic thyroid hormone. Synthroid has been sold for over 40 years, but was only officially approved by the Food & Drug Administration (FDA) in July 2002.
Synthroid has a long and controversial history. The drug was never subjected to formal review by the FDA. Synthroid was "grandfathered in" because it was similar to a previously approved natural hormone under then-existing regulations.
In 1997 the FDA ruled that Synthroid's manufacturer, Abbott Laboratories, had never demonstrated the potency and stability of the drug. As such, the FDA required that Synthroid undergo the agency's New Drug Approval process (NDA).
To date, at least two lawsuits have been filed against Abbott alleging that Synthroid's advertising campaigns were false and deceptive. Abbott settled both lawsuits for over $128 million.
Current research on Synthroid indicates that the drug can increase the risk of coronary problems in patients with cardiovascular disorders such as angina, coronary artery disease and hypertension. Additionally, dosage problems associated with Synthroid may cause patients to exhibit more intense symptoms of their thyroid disease.
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