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Teratogen
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FDA Guidelines only apply to...
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Teratology
Final study guide
| Question | Answer |
|---|---|
| Teratogen | Any environmental agent sucha s a drug, chemical infection or pollutant which potentially harms the developing fetus |
| FDA Guidelines only apply to... | pregnant women |
| FDA Guidelines A | Adequate studies in pregnant women have not demonstrated risk |
| FDA Guidelines B | Animal studies have not demonstrated risk but no studies in pregnant women OR animal studies suggest risk but human studies have not shown risk |
| FDA Guidelines C | Animal studies show risk but there are no human studies OR there are no studies in humans or laboratory animals |
| FDA Guidelines D | Evidence of human risk but benefits may make use acceptable |
| FDA Guidelines X | Studies show risk; risk of use clearly outweighs any possible benefit |
| Dangers of relying on FDA Pregnancy Categories | 1. Prevent quality clinical assessment of original studies 2. Only useful for prescribing, not retrospective risk assessment |
| What do you need to utilize other resources? | 1. Known teratogenic exposure 2. Complicated inquiry 3. Patient anxiety 4. Conflicting opinions |
| Strategies to Reduce Risk for previous ONTD | mg of folic acid prior to and during pregnancy |
| What plays into the effects of a teratogenic exposure? | 1. Route 2. Timing (critical period) 3. Dosage 4. Duration 5. genotype of fetus |
| Background risk for a baby to have a congenital anomaly is | 3% |
| Lithium | 1. Ebsteins anomaly, recommended fetal echocardiogram at 20 weeks, 3rd trimester use associated with neonatal cyanosis, hypotonia, disturbances of cardiac rhythm, diabetes insispidus and hypothyroidism. |
| Anticonvulsants: Worst one... | Depakote, Dilatin, Phenobarbatal |
| Chemotherapeutic agents | 1. Malformations 2. IUGR 3. Pancytopenia 4. CNS damage 5. Pregnancy loss 6. Cardiomyopathy 7. Prematurity 8 MR 9 Limb anomalies |
| ACE Inhibitors | Critical period of exposure: Second and third trimester IUGR, Hypocalcaria manifested by very large anterior fontanel, persistent PDA, renal tubular dysplasia leading to oligohydramnios and Potter's sequence |
| ACE inhibitors mechanism of action | reduce uterine blood flow, leading to decreased placental perfusion and severe fetal hypotension. Block fetal ACE activity, thereby affecting systemic and renal hemodynamics in the fetus |
| Anticonvulsants... potential risks | 1. Malformations 2. OB complications 3. hemorrhage and other problems in the newborn, 4 developmental delays 5. behaviorial problems |
| Anticonvulsant embryopathy | 1. Broad depressed nasal bridge 2. short nose with anteverted nares 3. Long philtrum 4. Maxillary hypoplasia 5. fingernail hypoplasia |
| Androgenic hormones | Masculinization of the female fetus, dose-dependent and critical period 8-13 weeks (labial fusion) later in pregnancy (clitoral hypertrophy) |
| DES critical period of development (andro. hormone) | up to 20 weeks gestation, highest risk for adenocarcinomas between weeks 10 and 13 |
| Fluconazole (Andro. hormone) | Antley-Bixler like phenotype, Pattern of malformations: brachycephaly, craniosynostosis, proptosis, low nasal brdige, cleft palate, femoral bowing, thin ribs and long bones' joint contractures, congenital heart defects |
| Retinoids | Isotretinoin, etretinate, tretinoin, dietary vitamin A, Patterns of malformations: CNS anomalies, ear anomalies, cardiovascular defects, thymus anomalies, intellectual deficiency |
| Critical period for isotretinoin/Retinoids | 15th day following conceptions through the end of the first trimester of pregnancy. |
| Tetracycline | increased risk for defects of primary teeth beyond the 4th month ofpregnancy, (binds to calcium) |
| Streptomycin | hearing loss (damage to the 8th nerve) |
| Thalidomide | Phocomelia, amelia, heart defects, renal and genitourinary anomalies, oral clefts, anomalies of the eyes and external ears |
| Warfarin | stippled epiphyses (between 6 and 9 weeks gestation) |
| Critical period for NTDs | 4-6 weeks |
| Critical period for MR | 7-16 weeks |
| less critical period for CNS | 32-38 weeks |
| Critical period for TA, ASD, and VSD | 3/5 through 6 weeks |
| less critical period for heart | 6 2/3rd through 8 weeks |
| Critical period for amelia/meromelia | 4 weeks to 6 weeks |
| Less critical period for upper limb | 6 weeks to 9 weeks |
| Less critical period for lower limb | 6 weeks to 9 weeks |
| Critical period for cleft lip | weeks 5 and 6 |
| less critical period for upper lip | weeks 7 and 8 |
| Low-set malformed ears and deafness | weks 4 through 9 |
| less critical period ears | weeks 9 through 16 |
| Critical period for microhthalmia, cataracts and glaucoma | weeks 4 through 8 |
| less critical period for eyes | weeks 8 through birth |
| critical period for enamal hypoplasia and staining | weeks 7 and 8 |
| less critical period for teeth | weeks 9 through birth |
| critical period for cleft palate | weeks 7 and 8 |
| less critical period and palate | week 9 |
| critical period for masculinization of female genitalia | weeks 7, 8 and 9 |
| less critical period for external genitalia | weeks 16 and 38 |
| What drugs are associated with clefting? | glucocorticoids and anticonvulsants |
| Chemotherapeutic agents critical period | 8-10 weeks gestation |
| ACE Inhibitors critical period | Second and third trimester |
| Androgenic hormones critical period | 8-13 weeks gestation |
Created by:
KChatham
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