Defective Thyroid Medication:

levothyroxine sodium

By Richard Alexander, Editor

Levothyroxine sodium is used as replacement therapy when endogenous thyroid hormone production is deficient. The maintenance dosage must be determined on a patient-by-patient basis.

Levothyroxine sodium products are marketed in multiple dosage strengths, that may vary by only 12 micrograms, thus permitting careful titration of dose. Because of levothyroxine sodium's narrow therapeutic index, it is particularly important that the amount of available active drug be consistent for a given tablet strength.

Variations in the amount of available active drug can affect both safety and effectiveness. Patients who receive superpotent tablets may experience angina, tachycardia, or arrhythmias. There is also evidence that overtreatment can cause osteoporosis. Subpotent tablets will not be effective in controlling hypothyroid symptoms or sequelae.

The drug substance levothyroxine sodium is unstable in the presence of light, temperature, air, and humidity.Levothyroxine sodium products may not be fully potent through the labeled expiration date, or be of consistent potency from lot to lot.

Such variations in product potency present actual safety and effectiveness are cause for serious concern.

No currently marketed orally administered levothyroxine sodium product has been shown to demonstrate consistent potency and stability and, thus, no currently marketed orally administered levothyroxine sodium product is generally recognized as safe and effective.

Levothyroxine sodium products are medically necessary because they are used to treat hypothyroidism and no alternative drug is relied upon by the medical community as an adequate substitute. Accordingly, FDA will permit orally administered levothyroxine sodium products to be marketed without approved New Drug Applications until August 14, 2000, in order to give manufacturers time to conduct the required studies and to prepare and submit applications, and to allow time for review of and action on these applications.

For more information contact William K. Hubbard, Associate Commissioner for Policy Coordination, United States Food and Drug Administration

[FR Doc. 97-21575 Filed 8-13-97; 8:45 am]
BILLING CODE 4160-01-F

1997.

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