Food and Drug

Administration Categories
for Drugs and Medication
Common Teratogens and Their Effects
CATEGORY A:

• Controlled studies in
humans have shown no
fetal risks.
-Multivitamins or prenatal
vitamins (not
“megavitamins”)
-Thyroid hormone
CATEGORY B:

Animal studies
demonstrate no fetal
risks, but there are no
human studies, or
adverse effects have
been demonstrated in
animals, but not in well-
controlled human
studies
• Insulin
CATEGORY C:

• There are no adequate animal or

human studies, or there are adverse
effects in animal studies but no
available human data
• Most of drugs or medications
commonly taken during pregnancy
are in this category
• Docusate sodium (Colace)
CATEGORY D:

• There is evidence of fetal

risk but benefits are thought
to outweigh these risks
-Carbamazepine and
Phenytoin
-Lithium citrate
CATEGORY X:

• Studies in animals or humans

show fetal abnormalities, or
adverse reaction reports
indicate evidence of fetal
risk.
• Proven fetal risks clearly
outweigh any benefits.
-Isotretinoin
CATEGORY X
Two principles govern drug intake during pregnancy:

1. any drug or herbal supplement may be

detrimental to fetal welfare.
2. a woman of childbearing age and ability
should take no drugs other than prescribed
by a physician, to avoid exposure to a drug
should she become pregnant
Example: Thalidomide
-

• Prescribed for morning sickness

-cause amelia or phocomelia
(total or partial absence of
extremities)
 Amelia and Phocomelia

• Amelia-absence of extremity Phocomelia

Phocomelia is a condition that
involves malformations of human
arms and legs. Although many
factors can cause phocomelia, the
prominent roots come from the
use of the drug thalidomide and
from genetic inheritance.
Occurrence in an individual
results in various abnormalities to
the face, limbs, ears, nose,
vessels and many other
underdevelopments.
Use of recreational drugs put fetus at risk:

1. may have direct teratogenic effect

2. IV drugs risk exposure to HIV & Hep. B
Example:
*Narcotics – (meperidine(Demerol), Heroin, Cocaine)
2. cause vasoconstriction
3. spontaneous miscarriage, preterm labor ,meconium staining and
intrauterine growth restriction
*Inhalants-(gasoline, lighter fluid, glue, nitrous oxide)
4. respiratory distress
5. limit oxygen supply to a fetus
Fetal Alcohol Syndrome

• Assessment Poor sucking reflex

Growth retardation Facial anomalies (strabismus, ptosis,
Difficulty establishing flat or absent groove above upper
respiration lip, short nose, thin upper lip
Irritability CNS dysfunction
Lethargy
Seizure activity
Click icon to add picture

Fetal Alcohol Syndrome (FAS)

Common Teratogens and Their Effects
 Fetal Alcohol Syndrome

• Treatment/Intervention

Prevention through education

Careful prenatal history and education
Identify women at risk with referral to
alcohol treatment centers
Prevent and treat respiratory distress
Promote parent-neonate attachment
Tobacco (Common Teratogens)

• Nicotine ,
cyanide , carbon Will cause: Fetal
monoxide growth restriction,
,cadmium , lead cleft lip and palate,
and sudden death
hydrocarbons
are potentials syndrome
teratogens
contained in
cigarette smoke.
Tobacco (Common Teratogens)

• Increased incidence of :

Spontaneous abortion ,placenta

previa and abruption and preterm
delivery, low birth weight infant