319 Test 1

Front 1

Pregnancy Risk Category A

Back 1

Remote Risk of Fetal Harm: Controlled studies in women have been done and have failed to demonstrate a risk of fetal harm during the first trimester, and there is no evidence of risk in later trimesters.

Front 2

Pregnancy Risk Category B

Back 2

Slightly More Risk Than A: Animal studies show no fetal risk, but controlled studies have not been done in women. or Animal studies do show a risk of fetal harm, but controlled studies in women have failed to demonstrate a risk during the first trimester, and there is no evidence of risk in later trimesters.

Front 3

Pregnancy Risk Category C

Back 3

Greater Risk Than B: Animal studies show a risk of fetal harm, but no controlled studies have been done in women. or No studies have been done in women or animals.

Front 4

Pregnancy Risk Category D

Back 4

Proven Risk of Fetal Harm: Studies in women show proof of fetal damage, but the potential benefits of use during pregnancy may be acceptable despite the risks (eg, treatment of life-threatening disease for which safer drugs are ineffective). A statement on risk will appear in the “WARNINGS” section of drug labeling.

Front 5

Pregnancy Risk Category X

Back 5

Proven Risk of Fetal Harm: Studies in women or animals show definite risk of fetal abnormality. or Adverse reaction reports indicate evidence of fetal risk. The risks clearly outweigh any possible benefit. A statement on risk will appear in the “CONTRAINDICATIONS” section of drug labeling.

Front 6

Cyclophosphamide

Back 6

CNS malformation, secondary cancer

Front 7

Methotrexate

Back 7

CNS and limb malformations

Front 8

Carbamazepine

Back 8

Neural tube defects

Front 9

Phenytoin

Back 9

Growth retardation, CNS defects

Front 10

Valproic acid

Back 10

Neural tube defects

Front 11

Androgens (eg, danazol)

Back 11

Masculinization of the female fetus

Front 12

Diethylstilbestrol

Back 12

Vaginal carcinoma in female offspring

Front 13

Alcohol

Back 13

Fetal alcohol syndrome, stillbirth, spontaneous abortion, low birth weight, mental retardation

Front 14

Angiotensin-converting enzyme inhibitors

Back 14

Renal failure, renal tubular dysgenesis, skull hypoplasia (from exposure during the second and third trimesters)

Front 15

Antithyroid drugs (propylthiouracil, methimazole)

Back 15

Goiter and hypothyroidism

Front 16

Isotretinoin and other vitamin A derivatives (etretinate, megadoses of vitamin A)

Back 16

Multiple defects (CNS, craniofacial, cardiovascular, others)

Front 17

Lithium

Back 17

Ebstein's anomaly (cardiac defects)

Front 18

Nonsteroidal anti-inflammatory drugs

Back 18

Premature closure of the ductus arteriosus

Front 19

Oral hypoglycemic drugs (eg, tolbutamide)

Back 19

Neonatal hypoglycemia

Front 20

Tetracycline

Back 20

Tooth and bone anomalies

Front 21

Thalidomide

Back 21

Shortened limbs, internal organ defects

Front 22

Warfarin

Back 22

Skeletal and CNS defects

Front 23

For the following reasons, human teratogens are extremely difficult to identify:

Back 23

• The incidence of congenital anomalies is generally low.
• Animal tests may not be applicable.
• Prolonged exposure may be required.
• Teratogenic effects may be delayed.
• Behavioral effects are difficult to document.
• Controlled experiments can't be done in humans.

Front 24

To prove that a drug is a teratogen, three criteria must be met:

Back 24

• The drug must cause a characteristic set of malformations.
• It must act only during a specific window of vulnerability (eg, weeks 4 through 7 of gestation).
• The incidence of malformations should increase with increasing dosage and duration of exposure.