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Adverse Drug Reactions
20-12-2018 1
Dr. Jervin
Defintion
• Any undesirable or unintended
consequence of drug administration
20/12/2018 2
Incidence
• 10-25%
• R/F Multiple drug therapy, elderly
20/12/2018 3
Classification
• A- Augmented (Predictable)
• B- Bizarre (Unpredictable)
• Minor- negligible
• Major- requires Rx
• Severe- intensive care
• Lethal- death
20/12/2018 4
Pharmacovigilance
• Science & activities related to
1. Detection
2. Assessment
3. Understanding
4. Prevention
Of ADR or any drug related problems
20/12/2018 5
1. Side effects
• @therapeutic doses
• Predictable
• Rx -> reduction in dose
• E.g.
– Atropine – preanaesthetic medication
– Codeine – cough -> constipation (traveler's
diarrhea)
20/12/2018 6
2.Secondary effects
• Indirect consequence of primary action
• E.g.
Tetracyclines-> Supression of bacteria
flora-> superinfections
20/12/2018 7
3. Toxic effects
• @ excessive doses
• Absolute / relative
20/12/2018 8
4. Intolerance
• @ therapeutic doses
• Appearance of characteristic toxic effects
of a drug in an individual
• Low threshold for drug
• E.g. carbamazepine -> ataxia
20/12/2018 9
5. Idiosyncrasy
• Genetically determined abnormal
reactivity to a chemical
• E.g. barbiturates -> excitation & confusion
20/12/2018 10
6. Drug allergy
• Immunologically mediated reactions
• Body considers drug as allergen
• Seen in small proportion of population
• Types : I , II, III, IV
• Rx :
 O2,
 Inj. Adrenaline 0.5mg (1:1000) im / 1:10,000 iv
 Antihistamines
 Glucocorticoids
• Prevention
– Skin tests (type I)
• Eg . Penicillins
20/12/2018 11
7. Photosensitivity
• Cutaneous reactions resulting from drug
induced sensitization of skin to UV rays
• Phototoxic
• Photo allergic
20/12/2018 12
Phototoxic
• Eg :
a/c : Tetracyclines
c/c : naldixic acid, Fluoroquinolones,
sulfones, Amiodarone.
20/12/2018 13
Drug/metabolite accumulates in skin
Absorbs light (Short wave length)
Photo biochemical reactions
Erythema, oedema , blisters
Hyperpigmentation, desquamation
Photoallergic
Drug
CMI
Papular,/eczematous contact dermatitis
20/12/2018 14
Light
(long wavelength)
Eg:
Sulfonamides
Sulfoylureas
Chloroquine
8. Drug dependence
• Psychological dependence
– E.g. Opioids, cocaine
• Physical dependence
– E.g. Opioids, barbiturates, alcohol
• Drug abuse
• Drug addiction
• Drug habituation
– E.g. Tea, coffee, smoking
20/12/2018 15
9. Drug withdrawal
• Adverse consequences in sudden
interruption of therapy
• E.g. Angina worsens when β-blockers
stopped suddenly
20/12/2018 16
10. Teratogenicity
• Capacity of a drug to cause foetal
abnormalities when given to pregnant
mother
• 3 Stages:
– Fertilization & Implantation (0-17)-Failure of
pregnancy
– Organogenesis† (18-55)- deformities
– Growth & development (56-) : Developmental
& functional abnormalities
• Avoided in pregnancy
20-12-2018 17
Risk category
• A – Human studies – No risk
• B - Animal Studies – No risk
• C – Potential benefit, no proper evidence
• D- Evidence of human foetal risk but
potential benefits outweigh
• X – potential risk
20/12/2018 18
Teratogenic drugs
• T- Thalidomide
• E- Epileptic drugs[Phenytoin, Phenobarbitone,
Carbamazepine, Valproate]
• R- Retinoids
• A- ACE –s; Alcohol ; Anticancer
• T- Thyroid drugs
• O- OCPs & Hormones
• G- Gonadotrophins
• E- Ergometrine
• N- NSAIDs- Aspirin, Indomethacin
• I-
• C- Coumarin , Warfarin
20-12-2018 19
• S- Sulfonamides
• A- Aminoglycosides
• F- Fluoroquinolones
• E- Erythromycin
• C- Clarithromycin
• T- Tetracycline
20-12-2018 20
11. Mutagenicity & Carinogenicity
• Capacity of a drug to cause genetic defects
• Capacity of a drug to cause cancer
• Eg:
–Anticancer drugs
–Radioisotopes
–Tobaco
20/12/2018 21
12. Iatrogenic diseases
• Drug induces diseases
• Eg ;
 Peptic ulcer- salicylates
 Parkinsonism – Phenothiazines, antipsychotics
 Hepatitis - isoniazid
20/12/2018 22
Dental adverse effects
• Xerostomia : atropine
• Oral candidiasis : Corticosteroids
• Gingival swelling : Phenytoin
• Oral ulcers : Aspirin
• Tooth discolouration : Tetracyclines
• Metallic taste : Metronidazole
20/12/2018 23

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Adverse drug reactions

  • 2. Defintion • Any undesirable or unintended consequence of drug administration 20/12/2018 2
  • 3. Incidence • 10-25% • R/F Multiple drug therapy, elderly 20/12/2018 3
  • 4. Classification • A- Augmented (Predictable) • B- Bizarre (Unpredictable) • Minor- negligible • Major- requires Rx • Severe- intensive care • Lethal- death 20/12/2018 4
  • 5. Pharmacovigilance • Science & activities related to 1. Detection 2. Assessment 3. Understanding 4. Prevention Of ADR or any drug related problems 20/12/2018 5
  • 6. 1. Side effects • @therapeutic doses • Predictable • Rx -> reduction in dose • E.g. – Atropine – preanaesthetic medication – Codeine – cough -> constipation (traveler's diarrhea) 20/12/2018 6
  • 7. 2.Secondary effects • Indirect consequence of primary action • E.g. Tetracyclines-> Supression of bacteria flora-> superinfections 20/12/2018 7
  • 8. 3. Toxic effects • @ excessive doses • Absolute / relative 20/12/2018 8
  • 9. 4. Intolerance • @ therapeutic doses • Appearance of characteristic toxic effects of a drug in an individual • Low threshold for drug • E.g. carbamazepine -> ataxia 20/12/2018 9
  • 10. 5. Idiosyncrasy • Genetically determined abnormal reactivity to a chemical • E.g. barbiturates -> excitation & confusion 20/12/2018 10
  • 11. 6. Drug allergy • Immunologically mediated reactions • Body considers drug as allergen • Seen in small proportion of population • Types : I , II, III, IV • Rx :  O2,  Inj. Adrenaline 0.5mg (1:1000) im / 1:10,000 iv  Antihistamines  Glucocorticoids • Prevention – Skin tests (type I) • Eg . Penicillins 20/12/2018 11
  • 12. 7. Photosensitivity • Cutaneous reactions resulting from drug induced sensitization of skin to UV rays • Phototoxic • Photo allergic 20/12/2018 12
  • 13. Phototoxic • Eg : a/c : Tetracyclines c/c : naldixic acid, Fluoroquinolones, sulfones, Amiodarone. 20/12/2018 13 Drug/metabolite accumulates in skin Absorbs light (Short wave length) Photo biochemical reactions Erythema, oedema , blisters Hyperpigmentation, desquamation
  • 14. Photoallergic Drug CMI Papular,/eczematous contact dermatitis 20/12/2018 14 Light (long wavelength) Eg: Sulfonamides Sulfoylureas Chloroquine
  • 15. 8. Drug dependence • Psychological dependence – E.g. Opioids, cocaine • Physical dependence – E.g. Opioids, barbiturates, alcohol • Drug abuse • Drug addiction • Drug habituation – E.g. Tea, coffee, smoking 20/12/2018 15
  • 16. 9. Drug withdrawal • Adverse consequences in sudden interruption of therapy • E.g. Angina worsens when β-blockers stopped suddenly 20/12/2018 16
  • 17. 10. Teratogenicity • Capacity of a drug to cause foetal abnormalities when given to pregnant mother • 3 Stages: – Fertilization & Implantation (0-17)-Failure of pregnancy – Organogenesis† (18-55)- deformities – Growth & development (56-) : Developmental & functional abnormalities • Avoided in pregnancy 20-12-2018 17
  • 18. Risk category • A – Human studies – No risk • B - Animal Studies – No risk • C – Potential benefit, no proper evidence • D- Evidence of human foetal risk but potential benefits outweigh • X – potential risk 20/12/2018 18
  • 19. Teratogenic drugs • T- Thalidomide • E- Epileptic drugs[Phenytoin, Phenobarbitone, Carbamazepine, Valproate] • R- Retinoids • A- ACE –s; Alcohol ; Anticancer • T- Thyroid drugs • O- OCPs & Hormones • G- Gonadotrophins • E- Ergometrine • N- NSAIDs- Aspirin, Indomethacin • I- • C- Coumarin , Warfarin 20-12-2018 19
  • 20. • S- Sulfonamides • A- Aminoglycosides • F- Fluoroquinolones • E- Erythromycin • C- Clarithromycin • T- Tetracycline 20-12-2018 20
  • 21. 11. Mutagenicity & Carinogenicity • Capacity of a drug to cause genetic defects • Capacity of a drug to cause cancer • Eg: –Anticancer drugs –Radioisotopes –Tobaco 20/12/2018 21
  • 22. 12. Iatrogenic diseases • Drug induces diseases • Eg ;  Peptic ulcer- salicylates  Parkinsonism – Phenothiazines, antipsychotics  Hepatitis - isoniazid 20/12/2018 22
  • 23. Dental adverse effects • Xerostomia : atropine • Oral candidiasis : Corticosteroids • Gingival swelling : Phenytoin • Oral ulcers : Aspirin • Tooth discolouration : Tetracyclines • Metallic taste : Metronidazole 20/12/2018 23