Teratogenicity.pptx

1. Teratogenicity
By: Dr. Sarita Sharma
Assistant Professor
Department of
Pharmacology
Mumbai

3. TERATOGEN
• Is an agent that can nd
drugs.
• directly or indirectly, causes a
structural or functional change in
the fetus or child if it is
administrated to pregnant mother
• If mother is taking this drug, It
can be either stopped, switched
or reduced to the lowest dose
possible
• typically during sensitive periods
of fetal development
• depending on the particular
teratogenic process and target
organ
TERATOGENIC DRUG
• Is an agent that can disturb
the development of the
embryo or fetus
• Teratogens halt the
pregnancy or produce a
congenital malformation
• Include radiation, maternal
infections, chemicals, and
drugs.

4. POSSIBLE SITES OF
ACTION OF TERATOGEN
DIRECT
TOXIC
ACTION
• FETUS:
-Direct toxicity.
-Metabolites toxic.
-Indirectly toxic, e.g.
anti-metabolites, anti-
vitamin.
-Pharmacodynamic
actions, e.g. on
cardiovascular system.
-Endocrine balance
altered
• FAETOPLACENTAL
UNIT:
-Umbilical cord, e.g.
spasm.
-Amniotic fluid volume
change.
-Faetal or maternal
placental blood flow.
-Placental transferof
• MOTHER:
-Nutritional changes,
e.g. vitamin or
mineral deficiencies.
-Biochemical
changes with
secondary effectson
the foetus, e.g.
hyperglycaemia.
-Endocrine balance
• FATHER:
-Sperm changes
INDIRECT
TOXIC
ACTION
• Cause malformation
-interfering with
faetal
metabolism
• Drugs:
-folic acid
antagonist
s
-antiepileptic drugs

5. TERATOGENIC MECHANISMS OF
MEDICAL DRUGS
Folate
antagonis
m
Neural cell
disruption
Endocrine
disruption
• Vascular
disruption
and specific
receptor
Oxidative
stress
Enzyme-
mediated
teratogenesis

6. •Analgesic
•Anticonvulsa
nt
•Anticoagulant
•Antidepressa
nt
•Antithyroid
•Vitamin A
•Metal toxic
•Sedative/
hypnotics
•Aminoglycosides

7. • Gastroschisis: birth defect:
• Decrease prostaglandin  decrease uterine
contraction delayed onset of labor &
prolonged period of pregnancy
• During delivery severe bleeding because
aspirin decrease platelet aggregation

8. TERATOGENIC
DRUGS IN
SECOND
TRIMESTER OF
PREGNANCY
ACE INHIBITORS &DIAZEPAM

11. 1) TETRACYCLINE
 Protein synthesis inhibitor
 Inhibitthe binding of aminoacyl-tRNA to the mRNA-
ribosomescomplex
Aminoacyl-tRNA mRNA-ribosomes complex
by binding to the 30S ribosomal subunit in mRNA
translationcomplex

12. SIDE EFFECTS
 IN PREGNANCY…..
 dental discolouration in chilren
 maternal hepatotoxicity with large parenteral doses

13. FDA PREGNANCY CATEGORIES
CATEGORY A
• failed to
demonstrat e
a risk to the
fetus in the
first
trimester of
pregnancy
• no evidence
of risk in later
trimesters
CATEGORY C
• shown an
adverse effect
on the fetus
• no adequate
and well-
controlled
studies in
humans
• potential
benefits may
warrant the
use of drug
despite
potential risks.
CATEGORY D
• positive
evidence of
human fetal
risk basedon
adverse
reaction data
• potential
benefits may
warrant use of
the drug in
pregnant
women
despite
potential risks
CATEGORY B
• failed to
demonstrate
a risk to the
fetus
• no adequate
and well-
controlled
studies in
pregnant
women.
CATEGORY X
• demonstrates
fetal
abnormalities
• positive
evidence of
human fetal
risk basedon
adverse
reaction data
• the risks
involved in use
of the drug in
pregnant
women
CATEGORY N
• FDA has
not
classified
the drug.