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U.S. FDA clears treatment for underactive thyroid

WASHINGTON (Reuters) -- U.S. health officials on Tuesday gave the first stamp of approval to one of the many drugs already marketed with a common ingredient for treating patients with underactive thyroid glands.

The Food and Drug Administration cleared Unithroid, a pill that contains levothyroxine, a chemical that is identical to a natural thyroid hormone.

Several drugs containing levothyroxine, the standard treatment for underactive thyroid glands, or hypothyroidism, have been sold in the United States without FDA approval since the 1950s.

A number of batches were recalled after problems with potency and quality, said Dr. John Jenkins, head of the FDA office that evaluates thyroid drugs. Thyroid hormone treatments must be carefully adjusted over time, Jenkins said, and products that degraded could impair proper therapy.

In response to the problem, the FDA notified manufacturers in 1997 that they must apply for approval in order to keep selling levothyroxine products. The goal was to give regulators, physicians and patients confidence in their quality and stability, Jenkins said.

"We now have one product that's been through that process and that meets that criteria," Jenkins said in an interview.

Hypothyroidism can stunt growth and intellectual development in children and cause weight gain, lethargy and other symptoms in adults.

Unithroid is manufactured by Jerome Stevens Pharmaceuticals of Bohemia, New York. Possible side effects from Unithroid include nervousness, weight loss, rapid heart beats, irritability and anxiety. Side effects usually occur from overdosing, the FDA said.

Manufacturers have until August 14, 2001, to apply for approval for products containing levothyroxine or face regulatory action.

Copyright 2000 Reuters. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.



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