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Pharmacovigilance01:19

Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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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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Basophil Activation Test for Investigation of IgE-Mediated Mechanisms in Drug Hypersensitivity
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Improving drug allergy label accuracy by supervised safety- and protocol-driven evaluation.

Chiara Jiamin Chong1, Karen Jui Lin Choo, Kheng Yong Ong

  • 1Department of Internal Medicine, Singapore General Hospital, Singapore.

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|December 1, 2022
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Summary

Most drug allergy labels are inaccurate, with 75% found to be false. Formal allergology evaluation, including prolonged drug challenges, is safe and effective for accurately diagnosing drug allergies.

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Area of Science:

  • Clinical Immunology
  • Pharmacovigilance
  • Allergy and Clinical Immunology

Background:

  • Self-reported drug allergies are common but often lack accuracy.
  • Formal diagnostic evaluation is needed to confirm or refute allergy labels.

Purpose of the Study:

  • To assess the utility and safety of formal allergology evaluations.
  • To identify factors associated with accurate drug allergy diagnoses.

Main Methods:

  • Prospective study of 331 patients undergoing drug allergy evaluations.
  • Inclusion of demographic data, reaction characteristics, and evaluation outcomes.
  • Risk stratification based on multidisciplinary consensus.

Main Results:

  • 75% of patients (248/331) had false drug allergy labels.
  • Positive results were found in 7% of skin tests, 13% of in-clinic challenges, and 17% of prolonged home challenges.
  • No anaphylaxis occurred during evaluations, indicating safety.

Conclusions:

  • Formal, risk-stratified drug allergy evaluations are safe and accurate.
  • Prolonged drug challenges enhance diagnostic sensitivity.
  • Accurate diagnosis can de-label patients with false allergy diagnoses.