Pharm 81 Teratogenic Drugs

Front 1

Leading cause of infant deaths

Back 1

Birth defects (20%)

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What % of babies are born with birth defects

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3-4%

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What percentage of birth defects are caused by drugs and environmental chemicals

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3-4%

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Def: Teratogen

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An agent or factor that causes morphological or functional alterations in teh exposed embryo/fetus

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Name 5 birth defects

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1. Physical - major malformations or minor anomalies
2. Developmental abnormalities
3. Deficits in intelligence
4. Disturbances in growth
5. Neoplasms

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4 Criteria for Establishing a Teratogen

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1. Genetics
2. Timing - developmental stage
3. Specificity - characteristic manifestation
4. Dose Effect

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When was thalidomide usually taken and what was the consequence

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24-36days postconception when limbs and heart were developing

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When are NSAID efffects the worst and why

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3rd trimester--> prolonged bleeding with labor and premature closure of ductus arteriosus

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Outcome of defects occuring in the first 2wks

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spontaneous abortion

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When is the fetus susceptible to...
1. major morphologic abnormalities
2. physiologic defects and minor morphologic abnormalities

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1. first 7wks
2. 8-38

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Animal studies limitations

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1. Different species have different responses. Rodents have high baseline of birth defects
2. Higher doses given to animals so results aren't alsways comparable to therapeutic doses

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Human studies limiations

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1. Can only study live births
2. Some malformations are difficult to assess at first
3. Many defecdts don't manifest until later in life

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Case-Control studies limitations

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Retrospective, so rely on the recollection of mothers. Moms are more likely to remember if htey took a drug if their babies were born with malformations

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Case-Control studies are best for...

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Id the odds ratio for moderate-risk teratogens. (What are hte odds that if the mother took the drug, the baby will be born with a certain abnormality)

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Cohort studies limitations

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prospective. Need to expose a lg no of women to obtain significant results. Takes long time to gather data

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Cohort studies are best for...

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id high-risk teratogens
Relative risk assessment

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MCC of birth defects

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alcohol

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Alcohol

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CNS and facial effects, growth retardation

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ACEI, ARBS

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renal failure, decreased skull ossification, renal tubular dysgenesis

Front 20

DOC for HTN in pregnancy

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methyldopa, labetalos

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DOC for hyperthyroidism during pregnancy

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Propylthiouracil

Front 22

Antithryoid Drugs

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Fetal goiter and hypothyroidism

Front 23

Name 3 antiepileptic drugs that are teratogenic

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Carbamazapine and Valproic acid --> neural tube defects
Phenytoin --> hypoplasia of fingers and toes, fetal hydantoin syndrome

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Fetal Hydantoin Syndrome

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low set ears, wide nose/mouth, short neck, strabismus caused by phenytoin

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Cocaine

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small for gestational age baby

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Diethylstilbestrol (DES)

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Vaginal carcinoma, GU defects in offspring

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Androgenic drugs

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masculinization of female fetus

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Hypoglycemic drugs

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neonatal hypoglycemia

Front 29

DOC for Diabetic pregnant moms

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Insulin

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Lithium

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Ebstein's Anomaly (downward displacement of tricuspid valve --> regurgitation into R. atrium w/ mild to severe symptoms)

Front 31

methotrexate

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CNS and limb malformations

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NSAIDS

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premature closure of ductus arteriosus and necrotizing enterocolitis

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Psychoactive drugs (barbiturates, opioids, benzo)

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Neonatal withdrawal syndrome when drug is taken late in pregnancy, lethal

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Smoking

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Small for gestational age
Vasoconstiction--> decreased o2 and nutrients to fetus
Increased spontaneous abortions and premature delivers

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What % of moms quit smoking while pregnant

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20%

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Retinoids (Isotretinoin)
1. Associated defect
2. FDA Cat

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1. CNS, cardio, craniofacial defects
2. X

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Tetracycline

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Anomalies of teeth, bones b/c it chelates Ca --> decreased availability

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Thalidomide

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Phocomelia, ear changes, internal organ defects

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Phocomelia

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very short or absent long bones and flipper-like appearance of hands and sometimes feet. Associated with thalidomide

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Warfarin

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Skeletal and CNS defects, Dandy-walker syndrome (malformation of cerebellum causing hydrocephalus)

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DOC for DVT in women of child-bearing age

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HMW Heparin b/c it can't cross BBB

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Drugs the affect the fetus the same as they do the mom

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1.Antithryroid
2. Enzyme Inducers
3. Drugs producing dependence
4. Oral hypoglycemics
5. Anticoags
6. CNS depressants
7. ototoxic agents

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FDA prenancy categories

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A Controlled studies in humans show no risk
B No evidence of risk in humans
C Risk can't be r/o.
D Positive evidence of risk
X Contraindicated

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What do you do if pt has adverse effects

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report to FDA (required)
CDC has surveillance system
Drug/vaccine manufacturers