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An epidemiologic study to compare the risk of severe hypersensitivity and

An epidemiologic study to compare the risk of severe hypersensitivity and 2025

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The document outlines the regulatory review process for the application of linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, intended for the treatment of type 2 diabetes mellitus. It includes details on post-marketing requirements (PMRs) and pediatric studies, emphasizing the need for epidemiological studies to assess risks of severe hypersensitivity reactions compared to other antidiabetic medications. The document also discusses labeling reviews, clinical trial inspections, and safety evaluations related to linagliptin's efficacy and safety profile.

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What is immediate and severe hypersensitivity reaction called?

Anaphylaxis is a severe, potentially life-threatening allergic reaction. It can occur within seconds or minutes of exposure to something youre allergic to, such as peanuts or bee stings.

What are the 4 major types of hypersensitivity reactions?

Type I: reaction mediated by IgE antibodies. Type II: cytotoxic reaction mediated by IgG or IgM antibodies. Type III: reaction mediated by immune complexes. Type IV: delayed reaction mediated by cellular response.

What is the difference between sensitization and hypersensitivity?

The sensitization stage is the primary immune response to an antigen, whereas the effector stage is a secondary immune response. In this context, hypersensitivity (HS) is defined as any excessive or abnormal secondary immune response to an antigen.

What is severe hypersensitivity reaction?

Anaphylaxis is a severe generalised allergic reaction. Symptoms generally occur within 20 minutes to 2 hours after exposure to the allergen and may quickly escalate, with the potential to become life-threatening.

What is the epidemiology of hypersensitivity reactions?

Adverse drug reactions affect 1020% of hospitalized patients and more than 7% of the general population. Severe reactions including anaphylaxis, drug hypersensitivity syndromes, Stevens Johnson syndrome and toxic epidermal necrolysis are also associated with significant morbidity and mortality.