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Adverse drug reactions associated with the use of biological agents.

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  • Additional Information
    • Source:
      Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
    • Publication Information:
      Original Publication: San Francisco, CA : Public Library of Science
    • Subject Terms:
      Antineoplastic Agents/*adverse effects ; Biological Products/*adverse effects ; Drug-Related Side Effects and Adverse Reactions/*epidemiology ; Immunologic Factors/*adverse effects; Adverse Drug Reaction Reporting Systems/statistics & numerical data ; Colombia/epidemiology ; Drug-Related Side Effects and Adverse Reactions/etiology ; Female ; Humans ; Incidence ; Male ; Patient Safety ; Pharmacovigilance ; Respiratory Tract Diseases/chemically induced ; Respiratory Tract Diseases/epidemiology ; Retrospective Studies ; Skin Diseases/chemically induced ; Skin Diseases/epidemiology
    • Abstract:
      Introduction: Biological drugs open new possibilities to treat diseases for which drug therapy is limited, but they may be associated with adverse drug reactions (ADRs).
      Objective: To identify the ADRs associated with the use of biological drugs in Colombia.
      Methods: This was a retrospective study of ADR reports from 2014 to 2019, contained in the database of Audifarma SA pharmacovigilance program. The ADRs, groups of associated drugs, and affected organs were classified.
      Results: In total, 5,415 reports of ADRs associated with biological drugs were identified in 78 Colombian cities. A total of 76.1% of the cases corresponded to women. The majority were classified as type A (55.0%) and B (28.9%), and 16.7% were serious cases. The respiratory tract was the most affected organ system (16.8%), followed by the skin and appendages (15.6%). Antineoplastic and immunomodulatory drugs accounted for 70.6% of the reports, and the drugs related to the greatest number of ADRs were adalimumab (12.2%) and etanercept (11.6%).
      Conclusions: The reporting of ADRs has increased in recent years and these reactions are mostly classified as tyoe A or B, categorized as serious in almost one-fifth of the reported cases and associated mainly with immunomodulators and antineoplastic agents. This type of study can support decision makers in ways that benefit patient safety and interaction with health systems.
      Competing Interests: Declaration of interest. The authors declare no conflicts of interest.
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    • Accession Number:
      0 (Antineoplastic Agents)
      0 (Biological Products)
      0 (Immunologic Factors)
    • Publication Date:
      Date Created: 20201218 Date Completed: 20210119 Latest Revision: 20210119
    • Publication Date:
      20240105
    • Accession Number:
      PMC7748267
    • Accession Number:
      10.1371/journal.pone.0240276
    • Accession Number:
      33338057