Generic and brand-name L-thyroxine are not bioequivalent for children with severe congenital hypothyroidism.

ABSTRACT:

Context

In the United States, generic substitution of levothyroxine (L-T(4)) by pharmacists is permitted if the formulations are deemed to be bioequivalent by the Federal Drug Administration, but there is widespread concern that the pharmacokinetic standard used is too insensitive.

Objective

We aimed to evaluate the bioequivalence of a brand-name L-T(4) (Synthroid) and an AB-rated generic formulation (Sandoz, Princeton, NJ) in children with severe hypothyroidism.

Design

This was a prospective randomized crossover study in which patients received 8 weeks of one L-T(4) formulation followed by 8 weeks of the other.

Setting

The setting was an academic medical center.

Patients

Of 31 children with an initial serum TSH concentration >100 mU/L, 20 had congenital

SUBMITTER: Carswell JM 

PROVIDER: S-EPMC3565118 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature