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L-T 4 Bioequivalence : Potential Impact on IQ in Babies with Congenital Hypothyroidism

L-T 4 Bioequivalence : Potential Impact on IQ in Babies with Congenital Hypothyroidism. Rosalind Brown MD, Children’s Hospital, Boston Harvard Medical School. Congenital Hypothyroidism. Because newborns are asymptomatic at birth, screening programs developed worldwide Incidence 1 in 3,000

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L-T 4 Bioequivalence : Potential Impact on IQ in Babies with Congenital Hypothyroidism

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  1. L-T4 Bioequivalence: Potential Impact on IQ in Babies with Congenital Hypothyroidism Rosalind Brown MD, Children’s Hospital, Boston Harvard Medical School

  2. Congenital Hypothyroidism • Because newborns are asymptomatic at birth, screening programs developed worldwide • Incidence 1 in 3,000 • One of the commonest treatable causes of mental retardation

  3. Untreated CH Patients at Risk for Severe Mental Retardation Klein et al, J Pediatr 81:912-915, 1972

  4. IQ of CH patients is normal if treatment early and adequate NECHC. Lancet 2:1095-1098, 1981

  5. But small differences in T4 dose have enormous impact on IQ T4 dose * MDI- Mental Development Index Bongers-Shokking JJ et al, J Pediatr 136:292-297,2000

  6. Conclusions • Small differences in L-T4 dose can have significant, irreversible consequences on IQ • A potential difference of 33% in drug content therefore unacceptable • T4 bioequivalence should be determined by the most sensitive means possible, that is by measurement of TSH

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