2 Bsn-A - Group 2

UNIVERSITY OF SOUTHERN MINDANAO
NCM 06
Pharamacology
Drug Therapy During Pregnancy:
Teratogenesis
Ansing , Rhever Jude
De Guzman, Rico Andrei Jefferson
Liberato , Faye Nicole
Silao, Cristina Sofia
Villanueva, Pearl Andrea
Outline:
•Incidence And Causes of Congenital

Anomalies
•Teratogenesis and Stage of Development
• FDA Pregnancy Risk Categories And New
Labelling Rules
Insert Running Title 2

Objective/Learning Outcomes:
• To Identify the Incidences and Cause of Congenital

Anomalies
• To Learn the Effect of Teratogens to the Stages of
Development of Fetus
• To Identify the Pregnancy Risk Categories and
Learn the New Labelling Rules
Incidence and Causes of Congenital
Anomalies:
Incidence:
Congenital anomalies occur in approximately
2-3% of all live births. They are a leading cause
of infant mortality and long-term disabilities.

Anomalies:
Causes:
 Genetic Factors:
• Mutations or alterations in a person's DNA can lead
to congenital anomalies. Chromosomal
abnormalities, such as Down syndrome (Trisomy
21), are examples.
Environmental Factors:
• Exposure to teratogens (substances that can disrupt
fetal development) during pregnancy.
o Examples include alcohol, tobacco, certain
medications, and infections like rubella.Insert Running Title 5
Anomalies:
Causes:
Maternal Health:
• The mother's health and nutrition during
pregnancy can influence fetal development.
Conditions like diabetes, obesity, and inadequate
prenatal care can increase the risk.
Infections:
• Viral or bacterial infections during pregnancy can
affect the developing fetus. Zika virus,
cytomegalovirus (CMV), and toxoplasmosis are
potential culprits. 6
Anomalies:
Causes:
Radiation:
• Exposure to ionizing radiation during pregnancy
can harm fetal development. Medical
procedures like X-rays and certain cancer
treatments are a concern.
Maternal Age:
• Advanced maternal age (over 35) is associated
with a higher risk of certain congenital
anomalies. 7
Anomalies:
Causes:
Unknown Factors:
• In some cases, the exact cause remains
unidentified, suggesting complex interactions of
genetic and environmental factors.
8
Teratogenesis and Stage of Development
• Fetal sensitivity to teratogens changes during development

• The effect of a teratogen is highly dependent upon when
the drug is given.
Development occurs in three major

stages:
1. The preimplantation/presomite period
(conception through week 2)
2. The embryonic period (weeks 3 through 8)
3. The fetal period (week 9 through term)
During the preimplantation/presomite period,

teratogens act in an “all-or-nothing” fashion.
 if the dose is sufficiently high, the result is
death of the conceptus.
 if the dose is sublethal, the conceptus is
likely to recover fully.

Gross malformations are produced by exposure

to teratogens during the embryonic period
(roughly the first trimester).
 the time when the basic shape of internal
organs and other structures is being
established.
 fetus is especially vulnerable during the
embryonic period

Teratogen exposure during the fetal period (i.e.,

the second and third trimesters)
 disrupts function rather than gross anatomy.
 growth and development of the brain are
important.
o Disruption of brain development can result
in learning deficits and behavioral
abnormalities.


FDA Pregnancy Risk Category
In 1979, the FDA established a system for

classifying drugs according to their probable risk to
the fetus.
 Have five categories
oCategory A
oCategory B
oCategory C
oCategory D
oCategory X
Category A
• Controlled studies in women fail to demonstrate
a risk to the fetus in the 1st trimester (and there
is no evidence of a risk in later trimesters), and
the possibility of fetal harm remains remote.
o Example drugs or substance: levothyroxine,
folic acid, liothyronine

Category B
• Either animal-reproduction studies have not
demonstrated a fetal risk but there are no
controlled studies in pregnant women or animal-
reproduction studies have shown an adverse effect
(other than a decrease in fertility) that was not
confirmed in controlled studies in women in the 1st
trimester (and there is no evidence of a risk in
later trimesters
o Example drugs: metformin, hydrochlorothiazide,
cyclobenzaprine, amoxicillin
Category D
• There is positive evidence of human fetal risk,
but the benefits from use in pregnant women
may be acceptable despite the risk (e.g., if the
drug is needed in a life-threatening situation or
for a serious disease for which safer drugs cannot
be used or are ineffective).
o Example drugs: losartan

Category X
• Studies in animals or human beings have
demonstrated fetal abnormalities or there is
evidence of fetal risk based on human
experience or both, and the risk of the use of the
drug in pregnant women clearly outweighs any
possible benefit. The drug is contraindicated in
women who are or may become pregnant.
o Example drugs: atorvastatin, simvastatin,
methotrexate, finasteride
References
o Burchum, J., & Rosenthal, L. (2018). Lehne’s
pharmacology for nursing care (10th ed.).
Saunders.
o FDA Pregnancy Categories. (n.d.). Drugs.com.
https://www.drugs.com/pregnancy-categories.ht
ml#:~:text=In%201979%2C%20the%20FDA%20
established,the%20risk%20to%20benefit%20rati
o
.
o Pregnancy: Introduction. (2023, July 3).
Medicines learning portal. Retrieved September
17, 2023, from 19
UNIVERSITY OF SOUTHERN MINDANAO
THANK YOU!
Ansing , Rhever Jude

De Guzman, Rico Andrei Jefferson
Liberato , Faye Nicole
Silao, Cristina Sofia
Villanueva, Pearl Andrea

2 Bsn-A - Group 2

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UNIVERSITY OF SOUTHERN MINDANAO

•Incidence And Causes of Congenital

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• To Identify the Incidences and Cause of Congenital

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• Fetal sensitivity to teratogens changes during development

Development occurs in three major

During the preimplantation/presomite period,

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Gross malformations are produced by exposure

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Teratogen exposure during the fetal period (i.e.,

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In 1979, the FDA established a system for

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Ansing , Rhever Jude

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