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Related Concept Videos

Allergic Reactions: Anaphylaxis01:30

Allergic Reactions: Anaphylaxis

172
Anaphylaxis is a severe, life-threatening hypersensitivity reaction mediated by Immunoglobulin E (IgE) antibodies. When IgE binds to allergens, it triggers the release of mediators– histamine, leukotrienes, and prostaglandins from mast cells and basophils. These mediators cause vasodilation, edema, and inflammation, leading to various symptoms.The primary allergens causing anaphylaxis include food items (e.g., peanuts, shellfish), drugs (e.g., penicillin, asparaginase, corticotropin,...
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Drug Toxicity: Allergic Reactions01:30

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Drug-related allergies are immune-mediated responses triggered by the administration of pharmacological agents. These hypersensitivity reactions are classified based on the immune mechanisms involved. The four primary types—Type I, II, III, and IV—are mediated by different immunological pathways and exhibit distinct clinical manifestations.Type I Hypersensitivity/ IgE-Mediated Reactions: Immunoglobulin E (IgE) immediately mediates Type I hypersensitivity reactions. Upon initial...
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Allergic reactions related to drugs are hypersensitivity responses driven by the immune system and bear no connection to the drug's therapeutic action. While drugs in isolation do not trigger an immune response, they can interact with endogenous proteins to form antigens. These antigens stimulate lymphocytes to produce antibodies. IgE-type antibodies attach themselves to mast cells. Upon subsequent exposure to the same stimulus, the antigen-antibody interaction is initiated, unleashing...
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Hypersensitivity Reactions: Delayed Hypersensitivity Reactions01:29

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187
Delayed-Type Hypersensitivity (DTH), or Type IV hypersensitivity, is a cell-mediated immune response. It occurs when T cells, rather than antibodies, mediate a reaction to specific antigens. It is characterized by a delayed onset (1-2 days) and involves the recruitment of macrophages to the inflammation site.The initiation of a DTH response begins with the sensitization of T cells. During this phase, which lasts at least 1-2 weeks, antigen-specific T cells are activated, clonally expanded, and...
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Drug toxicity: Idiosyncratic Reactions01:16

Drug toxicity: Idiosyncratic Reactions

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Idiosyncratic drug reactions represent abnormal chemical responses that vary significantly among individuals, ranging from extreme sensitivity to low doses to insensitivity to high doses. These reactions often occur due to the drug's covalent binding with serum proteins, forming a foreign hapten that triggers an immunotoxicological response. The variability in drug reactions has a strong pharmacogenetic foundation, with genetic differences crucial in how individuals metabolize drugs. For...
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Dynamic Light Scattering Analysis for the Determination of the Particle Size of Iron-Carbohydrate Complexes
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Comparative Risk of Anaphylactic Reactions Associated With Intravenous Iron Products.

Cunlin Wang1, David J Graham1, Robert C Kane2

  • 1Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.

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|November 18, 2015
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Summary

The risk of anaphylaxis from intravenous (IV) iron dextran is significantly higher than from other IV iron products. Iron sucrose demonstrated the lowest anaphylaxis risk among all tested IV iron formulations.

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Area of Science:

  • Pharmacovigilance
  • Clinical Pharmacology
  • Health Services Research

Background:

  • Intravenous (IV) iron products are associated with anaphylaxis, but comparative safety data are limited.
  • Understanding the comparative risk of anaphylaxis across different IV iron formulations is crucial for patient safety.

Purpose of the Study:

  • To compare the anaphylaxis risk among various marketed intravenous iron products.
  • To identify which IV iron formulations pose the highest and lowest risk of anaphylaxis.

Main Methods:

  • Retrospective cohort study of 688,183 US Medicare beneficiaries from 2003-2013.
  • Anaphylaxis risk was assessed for IV iron dextran, gluconate, sucrose, and ferumoxytol using validated algorithms on claims data.
  • Adjusted odds ratios were calculated to compare anaphylaxis risks between different IV iron products.

Main Results:

  • The risk of anaphylaxis at first exposure was significantly higher for iron dextran (68/100,000) compared to all other IV iron products combined (24/100,000).
  • Compared to iron sucrose, iron dextran had a 3.6-fold increased odds of anaphylaxis, iron gluconate 2.0-fold, and ferumoxytol 2.2-fold.
  • The cumulative risk of anaphylaxis after 1000 mg of iron repletion was highest for iron dextran (82/100,000) and lowest for iron sucrose (21/100,000).

Conclusions:

  • Iron dextran is associated with the highest risk of anaphylaxis among IV iron products in the US Medicare nondialysis population.
  • Iron sucrose appears to be the safest IV iron formulation regarding anaphylaxis risk.