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Diagnosis of Adverse Reactions to Drugs

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A special issue of Diagnostics (ISSN 2075-4418). This special issue belongs to the section "Pathology and Molecular Diagnostics".

Deadline for manuscript submissions: closed (31 December 2023) | Viewed by 10146

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Special Issue Editors

Dr. Elena Ramírez

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Guest Editor

Clinical Pharmacology, La Paz University Hospital – IdiPAZ, School of Medicine, Universidad Autónoma de Madrid, 28026 Madrid, Spain
Interests: clinical pharmacology; drug safety; adverse drug events; adverse drug reactions

Dr. Miguel González-Muñoz

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Guest Editor

Unit of Immunology, La Paz University Hospital, 28046 Madrid, Spain
Interests: immunology; allergy; adverse drug reactions

Special Issue Information

Dear Colleagues,

Adverse drug reactions (ADRs) affect all body organ systems and vary widely in severity. According to the World Health Organization, ADRs are one of the most common causes of morbidity and mortality; thus, they represent a financial burden for health care providers and the pharmaceutical industry. Non-serious ADRs are often resolved rapidly after removal of the casual drug; sometimes, after dose reduction, re-administration of the suspicious drug with the subsequent reappearance of the ADR is the gold standard diagnostic. However, in serious ADRs, which can lead to significant injury to organs/tissues which can be fatal, re-exposure is contraindicated for ethical reasons because its effects can be deadly. Most serious ADRs appear in the post-commercialization period. Therefore, a series of stakeholders would benefit from the development of solid diagnostics for early detection, and improve the forecast of serious ADRs.

Dr. Elena Ramírez
Dr. Miguel González-Muñoz
Guest Editors

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Keywords

adverse drug reactions
serious adverse drug reactions
unexpected adverse drug reactions
adverse drug events
drug-related side effects
drug safety
causality assessment of adverse drug reactions
diagnostic biomarker
non-immediate drug hypersensitivity reactions
immediate drug hypersensitivity reactions
pharmacogenetics
in vivo tests
in vitro tests

Published Papers (5 papers)

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Research

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14 pages, 1229 KiB

Open AccessArticle

The Effects of Moxifloxacin and Gemifloxacin on the ECG Morphology in Healthy Volunteers: A Phase 1 Randomized Clinical Trial

by Abid Ullah, Shujaat Ahmad, Niaz Ali, Haya Hussain, Mamdouh Allahyani, Mazen Almehmadi, Ahad Amer Alsaiari, Osama Abdulaziz, Feras Almarshad and Syeda Hajira Bukhari

Diagnostics 2023, 13(7), 1234; https://doi.org/10.3390/diagnostics13071234 - 24 Mar 2023

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Abstract

Moxifloxacin and gemifloxacin are the two newer broad-spectrum 8-methoxy-quinolone derivatives that are used to treat various bacterial infections in cardiac patients. In this research study, we assessed the impact of moxifloxacin and gemifloxacin on the QT intervals of electrocardiograms in normal adult doses and draw a comparison, in a controlled environment, on healthy volunteers. Additionally, the effect of both test drugs on the QRS complex was checked. Sixty healthy volunteers were randomly assigned to two groups via R-software, and each respectively received moxifloxacin and gemifloxacin for five days. The research ethics committee approved the research, and it was registered for clinical trial under NCT 04692623. The participants’ electrocardiograms were obtained before the start of the dose (baseline) and on the fifth day. Significant prolongation of QT interval was noted in moxifloxacin (p < 0.0001) as compared to gemifloxacin treated groups. There were no cases of QTc prolongation over the usual limits (450–470 ms) in the gemifloxacin-treated group, however, QTc prolongations at the rate of 30 and 60 ms from the baseline were noted, interpreted as per the EMEA guidelines. These findings indicate that moxifloxacin caused significant (p < 0.0001) QT interval prolongation (QTIP) as compared to gemifloxacin. In contrast to the previously reported literature, the prominent effect of moxifloxacin on the widening of the QRS-complex was noted with no such effect on QRS-widening in the gemifloxacin-treated group. It is concluded that both drugs have the potential for considerable QT interval prolongation (QTIP) effects, which is one of the risk factors for developing torsade de pointes (TdPs) in cardiac patients. Thus, clinicians should exercise caution when prescribing moxifloxacin and gemifloxacin to cardiac patients and should consider alternate treatment options. Full article

(This article belongs to the Special Issue Diagnosis of Adverse Reactions to Drugs)

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15 pages, 1227 KiB

Open AccessArticle

Diagnostic Value of Oral Provocation Tests in Drug Hypersensitivity Reactions Induced by Nonsteroidal Anti-Inflammatory Drugs and Paracetamol

by Iwona Popiolek, Magdalena Blasiak, Aleksandra Kozak, Ewelina Pietak, Malgorzata Bulanda and Grzegorz Porebski

Diagnostics 2022, 12(12), 3074; https://doi.org/10.3390/diagnostics12123074 - 07 Dec 2022

Cited by 2 | Viewed by 2288

Abstract

Oral drug provocation tests (DPT) are the basic diagnostic tool for the detection of hypersensitivity to non-opioid analgesics and for selecting a safe alternative for a patient. They are of great practical importance due to their common use, but the data on the follow-up of patients after negative DPT are still very scarce. We examined the further fate of 164 such adult patients after negative NSAID or paracetamol tests and analyzed which excipients in the studied drugs they could be exposed to after the diagnostic workup. A structured medical interview was performed 32.9 months (mean) after the provocation tests. Of the 164 patients, 131 (79.9%) retook the tested drug and 12 developed another hypersensitivity reaction, giving the estimated negative predictive value of 90.8%. These reactions were induced by acetylsalicylic acid, paracetamol, meloxicam, and diclofenac, and were clinically similar to the initial ones (most commonly urticaria and angioedema). There are 93 generics of these drugs on the local market, containing a total of 33 excipients for which hypersensitivity reactions have been reported. All available generics contain such excipients. Thirty-one patients (20.1%) did not take the previously tested drug again, most often because it was not needed or because they were afraid of another reaction. DPT with analgesics has a high diagnostic performance. A minority of patients had relapsed after reexposure. One of the underestimated reasons for this may be drug excipients provoking a reaction, so it is advisable to use exactly the same medical product that has been negatively tested. Many patients avoid reexposure to a given drug, despite negative tests, therefore very reliable patient education in connection with DPT is highly needed. Full article

(This article belongs to the Special Issue Diagnosis of Adverse Reactions to Drugs)

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10 pages, 680 KiB

Open AccessArticle

Is Omalizumab Related to Ear and Labyrinth Disorders? A Disproportionality Analysis Based on a Global Pharmacovigilance Database

by Hyeon Tae Park, Sunny Park, Yong Woo Jung and Soo An Choi

Diagnostics 2022, 12(10), 2434; https://doi.org/10.3390/diagnostics12102434 - 08 Oct 2022

Cited by 2 | Viewed by 1898

Abstract

Introduction: Asthma is a chronic disease, characterized by reversible airway obstruction, hypersensitivity reactions, and inflammation. Oral corticosteroids are an important treatment option for patients with severe or steroid-resistant asthma. Biologics for asthma are recommended in patients with severe asthma, owing to their steroid-sparing effect as well as their ability to reduce the severity and aggravation of uncontrolled asthma. Most clinical trials of omalizumab in patients with asthma have suggested its tolerability and safety. However, some studies reported eosinophilic comorbidities in the ear, nose, and throat during omalizumab treatment, particularly eosinophilic otitis media. This study examined the relationship between ear disorders and omalizumab compared with that of other biologics for asthma using a large real-world database. Materials and Methods: Individual case safety reports from the Uppsala Monitoring Centre Vigibase of biologics for asthma (omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab) up to 29 December 2019, were used. A disproportionality analysis was performed using the proportional reporting ratio (PRR), reporting odds ratio (ROR), and information components (IC). A hierarchy analysis used the Medical Dictionary for Regulatory Activities Terminology. A tree map was generated using R studio version 4.2. Results: In 32,618 omalizumab reports, 714 adverse events (AEs) were detected as signals. Among the 714 signals, seventeen AEs were detected as signals of omalizumab-related ear and labyrinth disorders in 394 reports. Only three AEs (ear pain, ear disorder, and ear discomfort) were detected from mepolizumab. No signal was detected from reslizumab, benralizumab, and dupilumab. Conclusions: Careful monitoring of ear disorders is recommended when omalizumab treatment is started, with decreased oral corticosteroid use in patients with severe asthma. Further studies are necessary to confirm the omalizumab-related signals. Full article

(This article belongs to the Special Issue Diagnosis of Adverse Reactions to Drugs)

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11 pages, 274 KiB

Open AccessArticle

Safety of Drugs Used during the First Wave of COVID-19: A Hospital-Registry-Based Study

by Cristina Aguilera, Immaculada Danés, Elena Guillén, Alba Vimes, Montserrat Bosch, Gloria Cereza, Adrián Sánchez-Montalvá, Isabel Campos-Varela, Marta Miarons, Jaume Mestre-Torres and Antònia Agustí

Diagnostics 2022, 12(7), 1612; https://doi.org/10.3390/diagnostics12071612 - 01 Jul 2022

Cited by 3 | Viewed by 1816

Abstract

The emergency of the coronavirus disease 2019 (COVID-19) pandemic led to the off-label use of drugs without data on their toxicity profiles in patients with COVID-19, or on their concomitant use. Patients included in the COVID-19 Patient Registry of a tertiary hospital during the first wave were analyzed to evaluate the adverse drug reactions (ADRs) with the selected treatments. Twenty-one percent of patients (197 out of 933) had at least one ADR, with a total of 240 ADRs. Patients with ADRs were more commonly treated with multiple drugs for COVID-19 infection than patients without ADRs (p < 0.001). They were younger (median 62 years vs. 70.1 years; p < 0.001) and took less medication regularly (69.5% vs. 75.7%; p = 0.031). The most frequent ADRs were gastrointestinal (67.1%), hepatobiliary (10.8%), and cardiac disorders (3.3%). Drugs more frequently involved included lopinavir/ritonavir (82.2%), hydroxychloroquine (72.1%), and azithromycin (66.5%). Although most ADRs recovered without sequelae, fatal cases were described, even though the role of the disease could not be completely ruled out. In similar situations, efforts should be made to use the drugs in the context of clinical trials, and to limit off-label use to those drugs with a better benefit/risk profile in specific situations and for patients at high risk of poor disease prognosis. Full article

(This article belongs to the Special Issue Diagnosis of Adverse Reactions to Drugs)

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8 pages, 2388 KiB

Open AccessCase Report

A Case Report of Intratesticular Hematoma in a Patient with Reiter’s Syndrome

by Jia-Jyun Jhang, Szu-Ju Chen, Chi-Ping Huang, Huey-Yi Chen, Wei-Ching Lin, Yung-Hsiang Chen and Wen-Chi Chen

Diagnostics 2023, 13(12), 1993; https://doi.org/10.3390/diagnostics13121993 - 07 Jun 2023

Cited by 2 | Viewed by 1528

Abstract

We present a case of a 28-year-old male patient with a spontaneous intratesticular hematoma. He had no history of trauma but experienced sudden onset of painful swelling in his right testis. Initially, testicular malignancy was suspected. The tumor marker of testis, including alfa-fetoprotein, lactic dehydrogenase, and β-human chorionic gonadotropin, was within normal range. The patient had been diagnosed with Reiter’s syndrome at the age of 20 and had been treated with sulfasalazine, non-steroidal anti-inflammatory drugs, and acetaminophen for eight years. Various imaging techniques before operation planning, including ultrasonography and computed tomography, revealed a hematoma that accounted for 32% of the testicular volume. During the waiting period before the operation, the patient was diagnosed with a hematoma and avoided a possible diagnosis of malignancy. Follow-up imaging with computed tomography and magnetic resonance imaging confirmed the presence of an intratesticular hematoma that had decreased in size. Since no other related factor contributed to this hematoma, and considering the possible hematological side effects of sulfasalazine, we suggest that this may be a rare side effect of sulfasalazine. Although the patient’s testis was preserved, further fertility should be observed because animal studies have reported that testicular hematoma may cause fertility changes if the initial volume occupied is over 30% of the testis. Full article

(This article belongs to the Special Issue Diagnosis of Adverse Reactions to Drugs)

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