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Adverse Drug Reaction. Unnikrishnan M K Additional Prof in Pharmacology, Manipal College of Pharmaceutical Sciences, Manipal 576 104. Introduction. Defn: Undesirable effect at normal dose: trivial OR serious Or fatal Requires Treatment  in dosing Discontinuation

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adverse drug reaction

Adverse Drug Reaction

Unnikrishnan M K

Additional Prof in Pharmacology,

Manipal College of Pharmaceutical Sciences,

Manipal 576 104

introduction
Introduction
  • Defn: Undesirable effect at normal dose:
    • trivial OR serious Or fatal
  • Requires
    • Treatment
    •  in dosing
    • Discontinuation
    • Caution in future
  • Occurrence
    • immediately or after prolonged use
    • or after termination
    • Mild ADRs common, [incidence 10-25%]
    •  with polypharmacy
  • Acceptability: linked to Therap. Use; Risk Benefit Ratio
type a predictable type b unpredictable
Type A: Predictable & Type B Unpredictable
  • Type A: Response qualitatively normal but quantitatively abnormal
  • Common, less serious, dose related,
  • corrected by dose adjustment
  • include side effect, toxic effect, withdrawal
  • Type B: Because of patient peculiarities; Eg. Allergy, idiosyncrasy
  • Dose related; uncommon; Serious  withdrawal of drug required
  • Not always predictable / preventable
severity of adr minor moderate severe lethal
Severity of ADR: Minor/ moderate/ severe/ lethal
  • Minor: no need of therapy, antidote, or hospitalization
  • Moderate: requires drug change , specific treatment, hospitalization
  • Severe: Potentially life threatening; permanent damage, and prolonged hospitalisation.
  • Lethal: Directly or indirectly leads to death
prevention of adr cannot be totally avoided only minimized
Prevention of ADR: [cannot be totally avoided; only minimized]

[1] Avoid inappropriate drugs in the context of clinical condition

[2] Use right dose, route, frequency based on patient variables

[3] Elicit medication history; consider untoward incidents

[4] Elicit history of allergies [in patients with allergic diseases]

[5] Rule out drug interactions

[6] Adopt right technique: Eg slow iv injection of aminophylline

[7] Carry out appropriate monitoring [Eg PT with warfarin; Li levels]

types of adrs viz side effect secondary effect toxic effect
Types of ADRs viz Side effect; Secondary effect; Toxic effect

[1] Side Effects: unavoidable, predictable, dose  amelioration

  • Occurs as Extension of the same therapeutic effect: Eg.
    • Atropine as antisecretory in preanesthetic medication  dry mouth
  • Occurs as a distinctly different effect: Eg.
    • Promethazine as antiallergic  sedation
    • Estrogen as antiovulatory  nausea
  • Side effect exploited for a therapeutic use: Eg
    • Codeine [antitussive] constipating action used in diarrhoea
    • Sulfonylureas [tested as antibacterials] were found tobl glucose
secondary effects toxic effects
Secondary Effects & Toxic Effects
  • [2] Secondary effects: Indirect effect of therapy
    • Eg. Iintestinal microflora killed by tetracycline superinfection
    • Corticosteroids  immunity  activation of latent tuberculosis
  • [3] Toxic effects: [Overdose or prolonged use]
    • Atropine  delirium ;
    • Paracetamol  hepatic necrosis
    • Barbiturates  coma;
    • Morphine  respiratory failure
intolerance and idiosyncrasy
Intolerance and Idiosyncrasy
  • [4] Intolerance:
    • Opposite of tolerance: sensitivity to low doses
    • few doses of carbamazepine  ataxia [ defective movement/gait]
    • single dose of triflupromazine  muscular dystonia
  • [5] Idiosyncrasy: genetically determined atypical / bizarre effect
    • Barbiturate  excitement & mental confusion
    • Quinine  cramps , diarrhoea, purpura, asthma, vascular collapse
drug allergy or hypersensitivity
Drug allergy: [ or hypersensitivity]
  • [6] Drug allergy: [ or hypersensitivity]
    • Immunologically mediated
    • Independent of dose
    • Occurs in a small proportion;
    • Prior sensitization required
    • 1-2 weeks required after first dose
    • Drug acts as an antigen or Hapten
    • Chemically related drugs may show cross sensitivity
    • Same drug can cause diff allergic reactions in diff individuals
drug allergy continued
Drug allergy: continued..
  • Variable time course: Sensitive people may later tolerate drug
  • Type I: urticaria, angioedema, asthma, anaphylactic shock
  • Type II: Thrombocytopenia, agranulocytosis, aplastic anemia, SLE
  • Type III: Arthralgia, lymphadenopathy, Steven Johnson Synd.
  • Type IV: contact dermatitis, fever, photosensitisation

Eg: penicillin, sulfonamides, carbamazepine, methyldopa

7 photosensitivity phototoxic photoallergic
[7]Photosensitivity: [phototoxic & photoallergic]
  • Phototoxic: Drug accumulates in skin  absorbs light  photochemical reaction  photobiological reaction  tissue damage [Eg erythema, edema, blistering etc] Eg tetracyclines
  • Photoallergic: drug  cell mediated immune response  contact dermatitis on exposure to light. Eg sulfonamides, griseofulvin etc.
adrs continued
ADRs continued..
  • [8]Drug Dependence: Psychological: (Habituation) & Physical dependence: with withdrawal symptoms
  • [9]Teratogenicity: Drug use in pregnancy affects offspring

Eg Thalidomide  phocomelia; phenytoin  cleft palate

  • [10 ]Carcinogenicity & mutagenicity:

Anticancer drugs, estrogens

  • [11] Drug induced deseases, Iatrogenic diseases : Salicylates  peptic ulcer;

Phenothiazines  parkinsonism; INH  hepatitis