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Class adverse drug reaction

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Adverse drug reaction
Adverse drug reaction
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Class adverse drug reaction

  1. 1. Dr. RAGHU PRASADA M S MBBS,MD ASSISTANT PROFESSOR DEPT. OF PHARMACOLOGY SSIMS & RC.
  2. 2.  An adverse drug reaction (ADR) is any untoward medical occurrence in a patient administered a pharmaceutical product, which is suspected to have a causal relationship with this treatment.  A response to a drug which is noxious and unintended, and which occurs at doses normally used in man.  Spontaneous reports from consumers and healthcare professionals should be regarded as suspected ADRs.
  3. 3.  Adverse Event (AE) – any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a casual relationship with this treatment  Serious Adverse Event (SAE) – AE that is either life- threatening, fatal, cause of prolong hospital admission, cause persistent disability or concern misuse or dependence
  4. 4. Adverse Drug Reaction (event attributed to drug) Adverse Event All Spontaneous reports Events not attributed to drug Diseases Other Drugs Environment Diet Genetics Compliance Other factors
  5. 5. Normal larynx Laryngeal oedema
  6. 6. ADR database No of reports: more than 3.5 million Each year increase ~160,000 / year
  7. 7. Withdrawn Drugs From the Market Drug Year Reason Lumiracoxib 2008 Hepatotoxicity Aprotinin 2008 Kidney and cardiovascular toxicity Tegaserod 2007 Cardiovascular ischemic events Ximelagatran 2006 Hepatotoxicity Valdecoxib 2005 Dermatology adverse events Pemoline 2005 Hepatotoxicity Rofecoxib 2004 Thrombotic cardiovascular events Levomethadyl 2003 Fatal Arrhytmia Rapacuronium 2001 Risk of fatal bronchospasm Cerivastatin 2001 Rhabdomyolosis Trovafloxacin 2001 Hepatotoxicity Amineptine 2000 Hepatotoxicity, dermatological side effects, abuse potential Cisapride 2000 Cardiac arrhythmias Troglitazone 2000 Hepatotoxicity
  8. 8. Drug Year Adverse Reaction Outcome Sulfanilamide 1937 Liver damage due to diethylene glycol Solvent changed; FDA established Thalidomide 1961 Congenital Malformations Withdrawn Chloramphenicol 1966 Blood Dyscrasias Uses restricted Benoxaprofan 1982 Liver damage Withdrawn Aspirin 1986 Reye’s syndrome Uses restricted Flecainide 1989 Cardiac Arrhythmias Uses restricted Noscapine 1991 Gene toxicity Withdrawn Triazolam 1991 Psychiatric disorders Withdrawn Withdrawn Drugs From the Market
  9. 9. drug year Adverse reaction Outcome Temafloxacin 1992 Various serious adverse effects Withdrawn Co-trimoxazole 1995 Serious allergic reactions Uses restricted Terfenadine 1997 Interactions (e.g. with grapefruit juice) Withdrawn from OTC sale Sotalol 1997 Cardiac arrhythmias Uses restricted Astemizole 1998 Interactions Withdrawn Cisapride 2000 Cardiac arrhythmias Withdrawn Cerivastatin 2001 Rhabdomylosis Withdrawn Withdrawn Drugs From the Market
  10. 10. Type A (Augumented): Common->1% Pharmacological mechanism based reactions Suggestive time relationship and Dose relationship Reproducible Ex- side effects, toxic effects Type B (Bizzare): (“Patient Reactions”) Immuno allergic reactions peculiarities related to patients Idiosyncrasy. Less common, non-dose related, Unexpected, Causality uncertain, Not reproducible experimentally Characteristic-serious, Rare <1% Anaphylaxis with penicillin
  11. 11. Type C adverse effects (Statistical effects) Often long latency Mechanism unknown Difficult to reproduce experimentally Associated with long term drug therapy E.g., Benzodiazepines dependence Analgesic Nephropathy Classification of adverse effects
  12. 12. Type D These reactions refers to teratogenic & carcinogenic effects These reactions are delayed in onset of action They are well known and can be anticipated Type E End of dose effects e.g. Abrupt cessation of corticosteroids produces acute adrenal insufficiency Propanolol – hypertension Type F Failure of therapy E.g. Anti tubercular therapy
  13. 13. MINOR No need of therapy MODERATE requires drug change, specific treatment, hospitalization SEVERE Potentially life threatening, permanent damage, prolonged hospitalization LETHAL Directly or indirectly lead to death
  14. 14. Type of rash Description Examples of drugs causing it Erythema multiform Target like lesions on the extensor surface of the limbs. Penicillamine Penicillin Sulphonamides Erythema nodosum Tender red nodules, sometimes with bruising on the extensor surface of the limbs. Phenobarbitals Sulphonamides Oral contraceptives Exfoliative dermatitis Red, scaly, Exfoliative lesions sometimes involving extensive areas of skin Carbamazepine Gold salts Phenylbutazone Pemphigus Widespread blistering Penicillamine Rifampicin Urticaria Red raised lesions surrounded by oedema often confluent Codiene Dextrans Penicillin
  15. 15. SIDE EFFECTS Unavoidable, predictable Occur at extension of same therapeutic effect E.g. Atropine - Dry mouth Promethazine – Sedation Estrogen (Antiovulatory) - Nausea Codeine (antitussive) –Constipation
  16. 16. Indirect consequences of primary effect of therapy E.g. microflora killed by tetracycline super infection Corticosteroids' (immunity) –Oral candidiasis
  17. 17. Over dose or prolonged use of drugs The manifestations are predictable and dose related They result from functional alteration or drug induced tissue damage Atropine – delirium Paracetamol – hepatic necrosis Barbiturates – coma Morphine – Respiratory failure
  18. 18. Appearance of characteristic toxic effects of a drug in an individual at therapeutic doses. Opposite to tolerance –sensitive to low doses Few doses of Carbamazipines causes ataxia, defective movement, goiter Single dose of Triflupromazine –Muscular dystonia
  19. 19. Genetically determined abnormal reactivity to a chemical atypical, bizarre effects Barbiturates- excitement & mental confusion Streptomycin –Deafness with single dose Deficiency of glucose 6 phosphate enzyme in individual, causes Haemorhoidal necrosis
  20. 20. Immunologically mediated reactions producing stereotype symptoms which are unrelated to pharmacodynamic profile of the drug Independent of dose Occur in small proportion Prior sensitization required 1-2 weeks required after 1st dose Drug acts as a Antigen Same drug may cause different allergy in different individuals
  21. 21. Classification (Gell & Coombs) Type I reactions (IgE-mediated) Type II reactions (cytotoxic) Type III reactions (immune complex) Type IV (delayed, cell mediated)
  22. 22. (anaphylaxis; immediate hypersensitivity): The drug or metabolite interacts with IgE molecules fixed to cells, particularly tissue mast cells and basophiles leukocytes. This triggers a process that lead to the release of pharmacological mediators like histamine, 5-HT, kinins, and arachidonic acid derivatives, which cause allergic response. Manifest as Urticaria, Rhinitis, Bronchial Asthma, Angio- oedema and Anaphylactic Shock. Drugs likely to cause type 1 are Penicillins, Streptomycin, Local Anaesthetics
  23. 23. Serious allergic reactions i.e. rapid in onset & may cause death It typically results in a no. of symptoms including an itchy, rashes , throat swelling & low B. P. On a pathologic level, anaphylaxis is due to Release of mediators or non immunologic mechanism Primary treatment is injection of Epinephrine with other complementary measures
  24. 24. Skin – Generalized hives Itchiness, Flushing Angiodema Swelling of tongue and throat Respiratory – Shortness of breath Wheeze Strider ( upper respiratory obstructions)
  25. 25. Can occur in response to almost any foreign substances Common trigger includes venom from insect bites & stings , food and medication Less common causes Physical factor - Exercise Biological agent , Latex hormonal changes, food additives (mono sodium glutamate) topical medications
  26. 26. It is due to release of inflammatory mediators & cytokines from mast cells & basophiles , typically due to immunological response Ig E + Antigens activates FcRi receptor on mast cells & basophil Lead to release of Histamines causes contraction of bronchial smooth muscle
  27. 27. Epinephrine (Adrenaline) - Is primary treatment for anaphylaxis with no absolute contra indications It is given I. m. into mid anterolateral thigh as soon as diagnosed The injection is repeated every 10- 20 min. if there is insufficiency response A second dose is administered 16- 30 % of episode
  28. 28. People on beta b can blockers may be resistant to the effect In that case I.v. glucagon can be administered Antihistamines (both H1 & H2) Corticosteroids Nebulized Salbutamol Use the Airway ,Breathing , Circulation, Disability, Exposure (ABCDE) approach to treat at primary level
  29. 29. Cytotoxic Reactions A circulating antibody of the IgG, IgM, or IgA class interact with an antigen formed by hapten. Complement is then activated and cell lysis occurs. Example: Thrombocytopenia, Haemolytic Anaemia Quinidine or Quinine.
  30. 30. Immune Complex Reactions Antibody (IgG) combines with antigen i.e. the hapten- protein complex in circulation Complex thus formed is deposited in the tissues, complement is activated, and damage to capillary endothelium results. Serum sickness is the typical drug reaction of this type. Penicillin, Sulfonamides & Anti-thyroiddrugs may be responsible.
  31. 31. Cell Mediated T-lymphocytes are sensitized by a hapten-protein antigenic complex. Inflammatory response ensues when lymphocytes come in contact with the antigen. E.g. Dermatitis caused by local anesthetic creams, topical antibiotics and antifungal creams. Pseudo Allergic Reactions: Term applied to reactions that resemble allergic reactions clinically but for which no immunological basis can be found. Asthma and Skin Rashes caused by aspirin are the examples
  32. 32. Phototoxic – drugs accumulates in skin absorbs light to give photochemical reactions, photo biologic reactions Eg. Erythma edema blistering Photo allergic- drugs with cell mediated immune response, contact dermatitis on exposure to light Eg. Sulfonamides, Griseofulvin
  33. 33. Drugs used in pregnancy affects offspring's Eg. Thalidomide - phocomalia Phenytoine – cleft palate Oral hypoglycemic- neonatal hypoglycemia Tetracycline– Anomaly of teeth & bones Valproic acid – neural tube disorder Warfarin - skeletal & CNS defects Carcinogenicity/ Mutagenicity Ant cancerous drugs Estrogen
  34. 34. Avoid inappropriate drugs in the context of clinical conditions Use right dose, route ,frequency based on patient variables Elicit medication history Elicit history of allergy Rule out drug interactions Adopt right technique of medication Carry out adequate monitoring-pharmacovigilance, Periodic Safety Update Reports (PSURs)
  35. 35. “All substances are poisons; there is none which is not a poison. The right dose differentiates a poison from a remedy.” Paracelsus (1493-1541) THANKYOU Download slides from Authorstream-presentations-raghuprasada Slideshare-presentations-raghuprasada Youtube-raghuprasada

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