exclusion of pregnant women
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Exclusion of Pregnant Women. Henry D. Royal, M.D. Associate Director Division of Nuclear Medicine Mallinckrodt Institute of Radiology Professor of Radiology Washington University School of Medicine St. Louis, MO. FDA Meeting 11/16/04. Overview. Radiation Risks During Pregnancy - PowerPoint PPT PresentationTRANSCRIPT
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Exclusion of Pregnant Women
Henry D. Royal, M.D.
Associate DirectorDivision of Nuclear Medicine
Mallinckrodt Institute of Radiology
Professor of RadiologyWashington University School of Medicine
St. Louis, MOFDA Meeting 11/16/04
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Overview
Radiation Risks During PregnancyPregnancy TestsMutagenesis
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Radiation Effects in Pregnancy
Dose to Embryo and FetusStage of GestationCongenital Abnormalities are
Deterministic EffectsChildhood Cancer is a
Stochastic Effect
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BEIR V Figure 6-1Fetal Dose (Gy)
0 1.00.50.2 0.30
0.1 1.5
10
20
30
40
50
60
70S
evere
Men
tal R
eta
rdati
on
(%
)
8-15 Weeks
All Gestational Ages
16-25 weeks
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BEIR V Figure 6-1
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BEIR V Figure 6-1
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Teratogenesis
Mental Retardation is the Greatest Effect 0.4% per Rem
Decrease in IQ0.3 Units per Rem
Risk is Greatest at 8-15 Weeks Threshold May Exists at 20-40 Rem
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Childhood Cancer
2.2 per 1,000 (0-15 years)Relative Risk: 1.4 per RemAbsolute Risk: 0.06% per Rem
(1 Cancer per 1700 children)
Controversial
ICRP 84 page 11, 2000
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0 10 20 30
Cases per 1,000 Births
GrowthRetardation
DevelopmentalAbnormalities
Viral Infections
ChromosomalAbnormalities
Risks of Pregnancy
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Occupational Exposure During Pregnancy
0.5 Rem During Entire Pregnancy 0.05 Rem/Month Once Pregnancy
Declared
NCRP Report 91, 1987
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Pregnancy Testing
Given That The Risk is Small With Fetal Doses in the Few 100 mRem Range, Written Attestation Should Suffice
For Fetal Doses > 1 Rem, a Pregnancy Test Would be Prudent
Pregnancy Tests Are Not Perfect
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Mutagenesis
Somatic vs
Germ Cells
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Mutagenesis
38,000 Parents75,000 BirthsNo Significant Differences in:1. Still Births2. Birth Weights3. Congenital
Abnormalities
4. Infant Mortality5. Child Mortality6. Leukemia7. Sex Ratio
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Rare Electrophorectic Variants
Mutagenesis
ExposedThree Probable Mutations in 667,404 Loci
ControlThree Probable Mutations in 466,881 Loci
No Significant Difference
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Not Demonstrated in HumansAbundant Evidence in Plants and Animals
at High Doses
Mutagenesis
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10 20 30 40 500
0.05
0.1
0.15
NEJM 328:114-120, 1993
Maternal Age
Pro
bab
ilit
yGenetic Effects
All
Down’s
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Conclusions About Mutagenesis
Immeasurable RiskPregnancy Should Only be Delayed If It is
Expected That the Health of the Mother Will Improve With Time