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Adverse drug reactions

Adverse drug reactions - Types. Definition, teratogenicity

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Adverse drug reactions

  1. 1. Adverse Drug Reactions 20-12-2018 1 Dr. Jervin
  2. 2. Defintion • Any undesirable or unintended consequence of drug administration 20/12/2018 2
  3. 3. Incidence • 10-25% • R/F Multiple drug therapy, elderly 20/12/2018 3
  4. 4. Classification • A- Augmented (Predictable) • B- Bizarre (Unpredictable) • Minor- negligible • Major- requires Rx • Severe- intensive care • Lethal- death 20/12/2018 4
  5. 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. 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. 7. 2.Secondary effects • Indirect consequence of primary action • E.g. Tetracyclines-> Supression of bacteria flora-> superinfections 20/12/2018 7
  8. 8. 3. Toxic effects • @ excessive doses • Absolute / relative 20/12/2018 8
  9. 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. 10. 5. Idiosyncrasy • Genetically determined abnormal reactivity to a chemical • E.g. barbiturates -> excitation & confusion 20/12/2018 10
  11. 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. 12. 7. Photosensitivity • Cutaneous reactions resulting from drug induced sensitization of skin to UV rays • Phototoxic • Photo allergic 20/12/2018 12
  13. 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. 14. Photoallergic Drug CMI Papular,/eczematous contact dermatitis 20/12/2018 14 Light (long wavelength) Eg: Sulfonamides Sulfoylureas Chloroquine
  15. 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. 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. 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. 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. 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. 20. • S- Sulfonamides • A- Aminoglycosides • F- Fluoroquinolones • E- Erythromycin • C- Clarithromycin • T- Tetracycline 20-12-2018 20
  21. 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. 22. 12. Iatrogenic diseases • Drug induces diseases • Eg ;  Peptic ulcer- salicylates  Parkinsonism – Phenothiazines, antipsychotics  Hepatitis - isoniazid 20/12/2018 22
  23. 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

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Adverse drug reactions - Types. Definition, teratogenicity

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