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Bioequivalence of generic Synthroid questioned.(Gynecology)
A recently approved generic formulation of levothyroxine "is significantly more potent" than Synthroid, and could lead to serious side effects if a patient were switched from one to the other, two clinical endocrinology organizations have warned.
Bioequivalence data used as the basis of the recent approval of a generic version of levothyroxine indicate that the generic--manufactured by Sandoz and approved in June--"may be as much as one-eighth more potent" than Synthroid, the American Thyroid Association (ATA) and the American Association of Clinical Endocrinologists (AACE) said in a statement.
This information "confirms our concern that current FDA standards defining the equivalence of levothyroxine products are too lax," and "switching between two products could compromise the effectiveness of treatment," resulting in serious side effects, AACE president Dr. Carlos Hamilton said in the statement.
Levothyroxine has a narrow toxic-to-therapeutic ratio, so "even minor or inadequate dosing" can result in problems for the patient, the statement said. ...
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Source: HighBeam Research, Bioequivalence of generic Synthroid questioned.(Gynecology)