as defined by WHO:
Are undesirable
Are unintentional
Are suspected (not necessarily
proven)
May develop as a consequence of
therapy or other procedure
ADR
Solvent
Excipients
Formulation
Contaminants produced in the
manufacturing process.
Pharmaceutical causes
particle size
nature and quantity of excipients and
coating material
quality and quantity present in
particular preparation
Pharmacokinetic causes
Pharmacodynamic causes
PREDISPOSING FACTORS
IN ADR
Patient-related factors
Drug-related factors
pharmaceutical properties
pharmacokinetic properties
pharmacodynamic properties
6 Classifications of ADR
Type
Type
Type
Type
Type
Type
A (Augmented)
B (Bizzare)
C (Continuous)
D (Delayed)
E (Ending Use)
F (Failure of Efficacy)
Type A or Augmented
Example:
Benzodiazepine
(anxiety
sedation and falls trauma
Furosemide
(diuresis)
electrolyte imbalance
neurosis)
water
and
Examples:
Captopril cough
Codeine constipation
Nitroglycerin headache
Characteristics of Bizzare
Reactions
1. no formal dose-response curve and
very small doses of the drug may
elicit the reaction once allergy or
idiosyncrasy is established
2.
reactions
disappears
discontinuation of the drug
on
Idiosyncrasy is an example of
bizzare reaction:
examples:
Genetic
Abnormality
Drugs
Idiosyncratic
Response
Abnormal
hemoglobin
Phenacitin
Sulfanilamides
Methemoglobinem
ia
Hemolytic anemia
Erythrocyte G6PDdeficiency
Aspirin
Sulfonamides
Vitamin C
Hemolytic anemia
Procaine
Local anesthetic
toxicity
Example:
Carcinogenesis
Hormonal
Gene toxicity
Suppression of immune response
Adverse Effects associated with
reproduction
teratogens
NOTE: