Chapter 3

Adverse Reactions

Mosby items and derived items © 2007 by Mosby, Inc., an affiliate of Elsevier Inc.

2 . local effects Mosby items and derived items © 2007 by Mosby.Adverse Reactions  Side Effects     Predictable Dose-related Acts on nontarget organs Examples include stomachache. vomiting. Inc. an affiliate of Elsevier Inc.. nausea. headache.

. an affiliate of Elsevier Inc. 3 .Adverse Reactions  Toxic Reactions      Predictable Dose-related Acts on target organs Extension of the drug’s pharmacologic effects Examples include hypoglycemia with an oral hypoglycemic agent or insulin Mosby items and derived items © 2007 by Mosby. Inc.

Inc..Adverse Reactions  Allergic Reactions   Not predictable Not dose-related Mosby items and derived items © 2007 by Mosby. 4 . an affiliate of Elsevier Inc.

Inc. 5 .. an affiliate of Elsevier Inc.Adverse Reactions  Allergic Reactions  Type 1 • Mediated by immunoglobulin E (IgE) antibodies • Anaphylactic shock or immediate hypersensitivity reactions  Type 2 • Complement-dependent reactions involving IgG or IgM antibodies • Examples include penicillin-induced hemolytic anemia Mosby items and derived items © 2007 by Mosby.

6 . Inc.Adverse Reactions  Allergic Reactions   Type III • Mediated by IgG • It is manifested as serum sickness Type IV • Delayed hypersensitivity reaction • Mediated by T lymphocytes and macrophages • Examples include allergic contact dermatitis Mosby items and derived items © 2007 by Mosby. an affiliate of Elsevier Inc..

. 7 . Some are due to an immunologic mechanism. Mosby items and derived items © 2007 by Mosby. an affiliate of Elsevier Inc. Inc.Adverse Reactions  Idiosyncratic Reactions    This is a reaction that is neither a side effect or an allergic reaction . Some are genetically determined abnormal reactions.

Toxicologic Evaluation of Drugs  Therapeutic Index (TI = LD50) ED50  An approximate statement of the relative safety of the drug expressed as the ratio of the lethal or toxic dose to the therapeutic dose of a drug  LD50: Minimum dose causing death in 50% of a sample population  ED50: Dose required to produce a specified intensity of effect in 50% of a sample population Mosby items and derived items © 2007 by Mosby.. 8 . Inc. an affiliate of Elsevier Inc.

safe dose range in humans. Inc. The drug is evaluated for safety and efficacy Postmarketing surveillance  Phase II Trials   Phase III Trials   Phase IV Trials  Mosby items and derived items © 2007 by Mosby.. and toxic effects of the drug The main purpose of this phase is to test for drug effectiveness and adverse effects Patients with the actual drug indication receive the drug. 9 .Drug Testing  Phase I Trials  Determines the biologic effects. an affiliate of Elsevier Inc.

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