Drugs in

Pregnancy
wahdi

Drugs in Pregnancy
The thalidomide tragedy, 40 years ago, leads to general
perception that all drugs, chemicals and environmental
exposures during early pregnancy are harmful to the
fetus
In reality, relative few proven human teratogens and
an increasing number of agents are shown to be safe
for use during human pregnancy

In the USA
3% are detectable at birth
12 14% by time at school
17% before the age 18 years

the PROBLEMS
More than half of pregnancies are unplanned
Should women with chronic illnesses - to stop
or not to stop medication
Up to date information is required
Balanced counseling about the safety of their
medications during pregnancy and lactation

What basic principles and outlines and

some of the important issues that need
to be addressed when counseling
Points for Discussions :
A. Agents with fetal effects
B. Determining drug safety inpregnancy
C. Categorization of drugs
D. Counseling and perception of risk
E. Drugs of choice in pregnancy ( Information Services
)

A. Agents with fetal effect

Teratogens
Interfere with the development of the fetus
inducing or in increasing the incidence of
congenital structural malformation, e.g. drugs,
illness.

Hadegens / Developmental Teratogens

Cause less visible malformation / functional
impairment, e.g. alcoholics, phenytoin.

Williams Obstetric 21 st ed. page 1008

 Fetotoxic Agents / embryotoxic

Induce growth restriction and death; without
malformations. Mostly because of the drug
pharmacological action, e.g. NSAID (3rd semester),
ACE Inhibitor.

Multiple Effects
e.g. rubella is teratogenic, hadegenic and fetotoxic
in the first trimester, but only hadegenic after 16th
weeks of pregnancy

B. Determining Drug Safety

Methodological & ethical difficulties

can not be
Other sources / animal studies
extrapolated to humans

Case reports
Epidemiological studies
No single approach

C. Categorization of Drug
Drugs are classified with regards to their safety
Categories on the basic of critical evaluation of the
available data ( human & animal )

A useful guide, but not always clear cut need balancing

Categorization of Risk of Drug Use in Pregnancy
( Med. Pregn. Working Party of the Austr. Drug Eval.
Commt (ADEC), categorized drug into Category A1, B1-3,
C, D, and X ) B1-3, human data are lacking, based on
animal data

Williams Obstetric 21 st ed. page 1009

D. Counseling & Perception of Risk

1) Must be based on the best available data
2) Accurate information and sensitive
counseling, will alleviate fears and
misconception, improve patient compliance
leading to improved management & outcome
3) Differences between man & woman ( believes,
religion, ethnic ) can influences decision making
(pregnancy, prenatal testing and termination of
pregnancy)
4) Each situation requires a different approach

Thing to be considered :
Risk perception
Counseling before pregnancy, during pregnancy
Retrospective counseling

E. Drug of Choice in Pregnancy

Principles that should guide the selection :

Use the lowest effective dose;

Avoid polytherapy were possible;
Uses older drug rather than new drug;
Avoid over - the - counter preparation
were possible.

Journal of Pediatric, Obstetrics and Gynaecology Sept/Oct 2002

Journal of Pediatrics, Obstetric and Gynaecologgy Jul/Aug 2001 page 38

Journal of Pediatrics, Obstetric and Gynaecologgy Jul/Aug 2001 page 39

Information Services

Multidisciplinary referral services

Telephone services
Face - to Face
Services available to doctors & other health
professional & general public.

References
Beischer. NA, Mackay EV., Obstetrics and the Newborn,
ch.65 p.618-639, WB Saunders Comp. 2nd Ed.
Tamizian. O, Arulkumaran. S, Drug Use in Pregnancy, J.of
Pediat. Ob & Gynec, Jul/Aug 2001, vol. 27 no. 4, p. 30 41.
Kennedy. D, Drugs in Pregnancy., J. Of Pediat. Ob & Gynec.,
Sept/Oct 2002, vol 28 no. 5, p.29-35.
Kennedy. D, Drugs in Pregnancy., J. Of Pediat. Ob &Gynec.,
Sept/Oct 2002, vol 28 no. 5, p.29-35.