Drug-Related Hypersensitivity Reactions Leading to Emergency Department: Original Data and Systematic Review

Abstract

The aim of the present study is to describe pharmacological characteristics of drug-related allergies and anaphylaxis leading to the emergency department (ED). An 8-year post hoc analysis on the MEREAFaPS Study database was performed (2012–2019). Subjects who experienced drug-related hypersensitivity leading to an ED visit were selected. Logistic regression analyses were used to estimate the reporting odds ratios (RORs) of drug-related allergies and anaphylaxis adjusting for sex, age classes, and ethnicity. In addition, a systematic review of observational studies evaluating drug-related hypersensitivity reactions leading to ED visits in outpatients was performed. Out of 94,073 ED visits, 14.4% cases were drug-related allergies and 0.6% were anaphylaxis. Females accounted for 56%. Multivariate logistic regression showed a higher risk of drug-related allergy among males and all age classes < 65 years, while a higher risk of anaphylaxis was observed for females (ROR 1.20 [1.01–1.42]) and adults (ROR 2.63 [2.21–3.14]). The systematic review included 37 studies. ED visits related to allergy and anaphylaxis ranged from 0.004% to 88%, and drug-related allergies and anaphylaxis ranged from 0.007% to 88%. Both in our analysis and in primary studies, antibacterials, analgesics, and radiocontrast agents were identified as the most common triggers of hypersensitivity.

Hospitalisations Related to the Combination of ACE Inhibitors and/or Angiotensin Receptor Blockers with Diuretics and NSAIDs: A Post Hoc Analysis on the Risks Associated with Triple Whammy

“…The present analysis included 80 patients (out of 61,855 cases collected in the MEREAFaPS database) exposed to the triple whammy who visited the ED of 94 general hospitals distributed in five Italian Regions (Lombardy, Piedmont, Tuscany, Emilia-Romagna, and Campania). More details, including the methodology applied for the construction of the MEREAFaPS database, can be found in our previous publications [10][11][12][13][14][15][16]. As already described, all pharmacovigilance report forms analysed here were all validated in terms of causality assessment using specific algorithms and/or scales (i.e., Naranjo scale) as requested by the Italian Medicines Agency and by the Italian Pharmacovigilance System legislation [10][11][12][13][14][15][16].…”

“…More details, including the methodology applied for the construction of the MEREAFaPS database, can be found in our previous publications [10][11][12][13][14][15][16]. As already described, all pharmacovigilance report forms analysed here were all validated in terms of causality assessment using specific algorithms and/or scales (i.e., Naranjo scale) as requested by the Italian Medicines Agency and by the Italian Pharmacovigilance System legislation [10][11][12][13][14][15][16]. Furthermore, a multidisciplinary team composed by experts in clinical pharmacology and toxicology, and pharmacoepidemiology, performed a thorough evaluation of cases included in the MEREAFaPS database, in order to maintain a high-quality standard of the data.…”

Pharmacovigilance and Pharmacoepidemiology as a Guarantee of Patient Safety: The Role of the Clinical Pharmacologist

“…These intrinsic characteristics of RCTs make their results far from representing the real-world population, thus not allowing an exhaustive assessment of the safety profile of drugs and vaccines. Consequently, post-marketing surveillance, also known as pharmacovigilance (during phase IV of drug development), plays a key role in better defining drugs’ and vaccines’ safety profiles in clinical practice, overcoming the gap of evidence derived from the pre-marketing phases [ 5 , 6 ]. These aspects are even more relevant if we consider that most CAM products (i.e., dietary supplements, herbal supplements, traditional Chinese medicine products, homoeopathic products, etc.)…”

“…These aspects are even more relevant if we consider that most CAM products (i.e., dietary supplements, herbal supplements, traditional Chinese medicine products, homoeopathic products, etc.) are placed on the market without first being tested on humans, even less in frailer subgroups [ 6 ].…”

“…In the frame of ED, active pharmacovigilance represents a valuable methodology, allowing healthcare professionals and researchers to detect, collect and characterise the clinical burden of ADRs [ 6 ], AEFIs [ 8 ], and adverse events associated with CAM products [ 9 , 10 ] in outpatients. Furthermore, active pharmacovigilance may help to recognise risk factors associated with adverse reactions among specific patient populations, such as the elderly (age ≥ 65 years) [ 11 ], women [ 7 ], including those in pregnancy or breastfeeding [ 12 , 13 ], children [ 14 ], subjects exposed to polypharmacy, or patients affected by substance use disorder [ 15 ].…”