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2013-10-04
Adverse effects
Alphabetic classification of types of
adverse drug effects
Type Type of effect Definition
Examples
A
Augmented
pharmacologic
al effects
Adverse effects that
are known to occur
from the pharmacology
of the drug, and are
dose related. They are
seldom fetal and
relatively common
Hypoglycemia
due to insulin
injection
Bradycardia due
to βadrenoreceptor
antagonists
B
Bizarre effects
Adverse effects that
occur unpredictably
and often have a high
morbidity and mortality.
They are uncommon
Anaphylaxis due
to penicillin
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Alphabetic classification of types of
adverse drug effects
Type Type of effect Definition
C
Chronic effects
Adverse effects that
only occur during
prolonged treatment and
not with single doses
D
Delayed
effects
Adverse effects that
occur remote from
treatment, either in the
children of treated
patients, or in patients
themselves years after
treatment
Examples
Iatrogenic
Cushing’s syndrom
with prednisolone
Colonic
dysfunction due to
laxatives
Carcinoma of the
vagina in the
daughters of
women who took
diethylstilbestrol
during pregnancy
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Alphabetic classification of types of
adverse drug effects
Type Type of effect Definition
E
End-oftreatment
effects
Adverse effects that
occur when a drug is
stopped, especially
when is stopped
suddenly (so-colled
withdrawal effects
Examples
Withdrawal
seizures when
anticonvulsants
such as
phenobarbital or
phenytoin are
stopped
Adrenocortical
insufficiency after
glucocorticosteroi
ds such as
prdnisolone are
stopped
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Human teratogenesis
• Teratogenesis is defined as the dysgenesis of
fetal organs as evidenced either structurally or
functionally (e.g., brain functions). The typical
manifestations of teratogenesis are restricted
growth or death of the fetus, carcinogensis,
and malformations, defined as defects in
organ sructure or function.
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FDA Drug Risk Classification in Pregnancy
• Category A
Adequate, well-controlled studies in pregnant
women have not shown an increased risk of
fetal abnormalities to the fetus in any
trimester of pregnancy.
Folic acid
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FDA Drug Risk Classification in Pregnancy
• Category B
• Animal studies have revealed no evidence of harm to
the fetus, however, there are no adequate and wellcontrolled studies in pregnant women.
OR
Animal studies have shown an adverse effect, but
adequate and well-controlled studies in pregnant
women have failed to demonstrate a risk to the fetus
in any trimester.
• Amoxicillin, Insulin
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FDA Drug Risk Classification in Pregnancy
• Category C
• Animal studies have shown an adverse effect and there are
no adequate and well-controlled studies in pregnant
women.
OR
No animal studies have been conducted and there are no
adequate and well-controlled studies in pregnant women.
• Drugs should be given only if the potential benefit justifies
the potential risk to the fetus.
• Fluoxetin, fluconazole
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FDA Drug Risk Classification in Pregnancy
• Category D
• There is positive evidence of human fetal risk
• Adequate well-controlled or observational studies in
pregnant women have demonstrated a risk to the fetus.
• However, the benefits of therapy may outweigh the
potential risk. For example, the drug may be acceptable if
needed in a life-threatening situation or serious disease
for which safer drugs cannot be used or are ineffective.
• Phenytoin, cancer chemotherapy
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FDA Drug Risk Classification in Pregnancy
• Category X
• Adequate well-controlled or observational
studies in animals or pregnant women have
demonstrated positive evidence of fetal
abnormalities or risks.
• The use of the product is contraindicated in
women who are or may become pregnant.
• Thalidomide, isotretinoin
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MedWatch Reporting by Consumers
• MedWatch is the Food and Drug
Administration's (FDA) program for reporting
serious reactions
and problems with medical products, such as
drugs and medical devices.
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