June 01, 2001 - Popular Thyroid Drug Faces Deadline
The Food and Drug Administration will not grant the status of "generally regarded as safe and effective drug'' to Synthroid, a widely used thyroid drug that has been on the market for more than 35 years if Abbott Laboratories does not meet the August deadline to get a formaln drug approval. Abbott had acquired Synthroid's manufacturer earlier this year.
However, the FDA has not decided what it will do if the August deadline to approve the drug is not met by Abbott.. The product could go off the market and patients could find themselves going back to their doctors and looking for other medicines. The drug's manufacturer did announced that it will seek a formal new-drug approval some time in the future.
Abbott Laboratories announced in April that it was filing a new drug application for the product, but the approval process can take more than 10 months.
The original manufacturer of Synthroid, Knoll Pharmaceutical Co., had already tried to place the product in a category known as "generally regarded as safe and effective,'' citing its long history of use. But because Synthroid's formula has changed over the years and the agency has investigated reports of problems with the drug's potency the FDA turned that offer down, noting that in order for a medication to be generally recognized as safe and effective, there must be some consistent drug product for experts to recognize.
Synthroid tablets are made using an "overage'' of the active ingredient that has varied in size. An overage occurs when the product contains more than the labeled amount of a chemical. This is intended to compensate for loss of the ingredient while the product is in storage, thus extending shelf life.
As a result, some patients may receive more than the listed dose, but too much of the drug can cause chest pain and rapid or irregular heartbeat. Others could receive less of Synthroid which could potentially lead to lethargy, mental impairment, depression, constipation and other problems.
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