The document discusses adverse drug reactions (ADRs). It defines ADRs and different types including: Type A reactions which are augmented/predictable effects; Type B which are bizarre/unpredictable; Type C seen with continuous use; Type D which are delayed effects; Type E occurring at the end of a dose; and Type F resulting from treatment failure. It provides examples and management strategies for each type of ADR.
3. Adverse drug reaction
According to WHO:
A response to a drug
which is noxious & unintended, which
occurs at doses normally used in man for
prophylaxis, diagnosis or therapy of disease
or for modification of physiological
function.
4. Unexpected Adverse Reaction :
An adverse reaction, the nature
or severity of which is not consistent with
- Domestic labelling
- Market authorization
- Expected from characteristics of the drug.
5. Adverse event:
Any untoward medical
occurrence that may present during
treatment with a pharmaceutical product
But does not necessarily have a causal
relationship with this treatment.
6. Serious Adverse Event or Reaction:
Any untoward medical occurrence that at
any dose :
results in death
requires inpatient hospitalisation or
prolongation of existing hospitalisation
results in persistent or significant
disability/incapacity
is life-threatening
7. TYPE - A (AUGMENTED / PREDICTABLE)
TYPE - B (BIZARRE / UNPREDICTABLE)
TYPE - C (CONTINUOUS DRUG USE)
TYPE - D (DELAYED)
TYPE - E (END OF DOSE)
TYPE - F (FAILURE OF THERAPY)
8. Commonest type (up to 70%)
Dose dependent, severity increases with
dose.
Predictable by the pharmacological
mechanisms
Managed by
- adjusting the dose of the drug,
- substituting a similar but more
selective drug
- giving additional drugs to antagonize
the untoward/unwanted effect of the
primary drug.
9. Examples:
- Hypotension by beta-blockers,
- Hypoglycaemia caused by insulins or oral
hypoglycaemics
- NSAIDs induced gastric ulcers
They include:
Side Effects
Secondary Effects
Toxic Effects
10. Side Effects:
Unwanted but often-unavoidable
pharmacodynamic effects that occur at
therapeutic doses
Produced By :
-Therapeutic effect-e.g. Atropine
- Another effect-e.g. Antipsychotics
- Therapeutic in one context
and side effect in other- e.g. Codeine
11. Toxic Effects :
Excessive pharmacological action of the drug due to
over dosage or prolonged use.
Produced By
Therapeutic effect extension
-e.g. Digoxin,Heparin
Another action-e.g. Morphine
Secondary Effects :
Indirect consequences of primary actions of the drug.
e.g. Tetracyclines, corticosteroids
12. Rare, idiosyncratic, genetically determined,
unpredictable.
Based on peculiarities of the patient & not on
mechanism of drugs
Unrelated to the dose
Serious, can be fatal
Managed by
- Prevention if genetic basis known
- Withdrawal of drug
13. Immunological – Drug allergy
(hypersensitivity)
Non immunological
◦ Intolerance
◦ Idiosyncratic reaction
14. DRUG ALLERGY
- An immunologically mediated reaction
producing serotype symptoms
- Unrelated to the pharmacodynamic
profile of the drug
- Independent of dosage
16. Offending drug must be immediately stopped
mild reactions (like skin rashes) subside by
themselves
Antihistamines in type 1 reactions
Anaphylactic shock
Put the patient in reclining position,
administer oxygen at high flow rate and
perform cardiopulmonary resuscitation if
required
17. Inject adrenaline 0.5 mg (0.5 ml of 1 in 1000
solution for adult,i.m or 1;10000 i.v
Chlorpheniramine (10–20 mg) i.m.
Hydrocortisone sod. succinate 200 mg i.v
18. Intolerance
- Toxic effects of a drug at therapeutic
doses.
- Indicates a low threshold of the individual
to the action of the drug.
- e.g. Carbamazepine induced ataxia
Idiosyncrasy
- Genetically determined abnormal
reactivity to a chemical
- e.g. Malignant hyper thermia after
halothane
19. Occurs as a result of continuous drug use.
Often a long latency and no suggestive time
relationship.
May be irreversible, unexpected,
unpredictable
e.g. tardive dyskinesias by antipsychotics
Managed by
- Reduction of dose
- Slow withdrawal of drug
20. Delayed occurrence of ADRs
Even after the cessation of treatment
Teratogenic adverse effects
Carcinogenic adverse effects
e.g. vaginal adenocarcinoma in teenage
female offspring of mothers administered
diethylstilbesterol during pregnancy
21. Occur when a drug is stopped
Withdrawal reactions
e.g. Seizures on alcohol or benzodiazepines
withdrawal
Rebound hypertension with clonidine
withdrawal.
Managed by
-Reintroduction & slow withdrawal of
drug
22. Results from the ineffective treatment
Often caused by administration of low dose or due
to drug interactions.
e.g., accelerated hypertension because of
inefficient control,
-OCPs failure with rifampicin.
Managed by
- increase in dose
- consideration of effects of concomitant
therapy
23. Mild Moderate Severe Lethal
No therapy,
antidote or
prolongation
of hospital
stay is
required
Requires change
in drug therapy,
special
treatment or
prolongation of
hospital stay
life threatening,
or permanently
disabling,
requiring
discontinuation
of drug and
intensive medical
care
Directly or
indirectly
contribute
s to the
patient's
death.
28. Use of drugs for personal satisfaction is given
a higher priority than other basic needs.
Psychological dependence:
Individual believes that
optimal state of wellbeing is achieved only
through the actions of the drug.
e.g. Opioids,
Cocaine,
BZDs
29. Physical dependence :
Altered physiological
state produced by repeated administration
of a drug which necessitates the continued
presence of the drug to maintain physiological
equilibrium.
Discontinuation-Withdrawal Syndrome
Neuroadaptation- As it is a process of
adaptation of the nervous
system.
Drugs- Opioids,Barbiturates,
Alcohol,Benzodiazepines etc
30. Capacity of the drug to cause foetal
abnormalities when administered to pregnant
mother.
Drugs can affect the foetus at 3 stages:
Fertilization and implantation
Organogenesis
Growth and development
31. DRUGS ABNORMALITY
Thalidomide Phocomelia, multiple defects
Progestins Virilization of female foetus
Stillbestrol Vaginal carcinoma in teenage female
offspring
Tetracyclines Discoloured & deformed teeth
Carbamazepine Neural tube defects
Valproate sodium Spina bifida and other neural tube
defects
Alcohol low IQ baby,foetal alcohol slmdrome
Lithium Foetal goiter, cardiac and other
abnormalities
Antithyroid drugs Foetal goiter and hypothyroidism
Indomethacin/aspirin Premature closure of ductus arteriosus
Isotretinoin Craniofacial,heart and CNS defects
32. Mutagenicity:
Capacity of a drug to cause genetic
defects.
Carcinogenicity:
Capacity of a drug to cause cancer
Drugs:
Anticancer drugs
Radioisotopes,
Estrogens,
Tobacco
33. Also known as- IATROGENIC or PHYSICIAN
INDUCED DISEASES
Persist even after the offending drug has
been withdrawn
e.g. Peptic Ulcer – Salicylates
Hepatitis – INH
DLE – Hydralazine
Parkinsonism - Phenothiazines
35. Type B adverse drug reaction is ?
(a) Augmented effect of the drug
(b) Allergic effect of the drug
(c) Effect seen on chronic use of the drug
(d) Delayed effect of the drug
36. A newborn baby was born with phocomelia. It
results due to which drug taken by mother
during pregnancy?
(a) Tetracycline
(b) Thalidomide
(c) Warfarin
(d) Alcohol
37.
38. All of the following are examples of time
dependent late adverse drug reactions
except:
(a) Glucocorticoid induced osteoporosis
(b) Nitrate induced headache
(c) Chloroquine induced retinopathy
(d) Amiodarone induced tissue phospholipid
deposition
39. There are some undesirable but unavoidable
pharmacodynamic effects of a drug, which
are known as:
(a) Toxic effects
(b) Idiosyncrasy
(c) Side effects
(d) Intolerance
40. In pregnancy, all of the following drugs are
contraindicated except:
(a) ACE Inhibitors
(b) Angiotensin Receptor Blockers
(c) Proplythiouracil
(d) Thalidomide
41. True about the teratogenicity of a drug is all
except:
(a) Characteristic set of malformations
indicating selectivity for certain target organs
is seen
(b) Heparin is highly teratogenic drug
(c) Related to the dose of the teratogenic
drug
(d) Affects specifically at a particular phase of
development of the fetus
42. All the following drugs are teratogenic
except:
(a) Alcohol
(b) Phenytoin
(c) Warfarin
(d) Metoclopramide
