Synthroid®
Manufacturer:
Abbott Laboratories
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| Synthroid |
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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