Drug Safety Monitoring Research Articles

When Patient Voices Get Lost in Evidence Hierarchies: A Testimony of Rare Adverse Events and Participatory Epistemic Injustice in Drug Safety Monitoring

ABSTRACT We explore an unsolved challenge in the era of evidence-based medicine (EBM): the recognition of the patient as an epistemic agent or ‘knower’. While patients are increasingly acknowledged as carriers of values and preferences, it seems more challenging to acknowledge them as carriers of important causal information. In contrast, the science of pharmacovigilance depends on patient testimonies as valuable sources of causal evidence. This incompatibility can give rise to cases of what has been called participatory epistemic injustice. We analyse the testimony of a chronic pain patient and co-author of this article, Christine. Christine gives an auto-ethnographic account of her interactions with healthcare professionals trying to find the right pharmacological treatment for her condition. Through the analysis of her own story, she identifies some relevant themes for the epistemic interaction between healthcare professionals and chronic pain patients. We argue that such epistemic interactions are increasingly shaped by EBM and its conception of causality, which devalues patient subjective testimonies and emphasises statistical evidence. We conclude that outlier patients face an inherent risk of being left vulnerable to participatory epistemic injustice, particularly regarding the discovery of novel, rare adverse effects of medicines.

Gauging Expert Perspectives: A Survey on AI Integration in Pharmacovigilance

Abstract: The ever-growing landscape of drug safety monitoring demands innovative solutions. This paper explores how Artificial Intelligence (AI) can revolutionize pharmacovigilance by enhancing patient safety and enabling personalized medicine. A survey conducted by the author indicates a positive outlook on AI's potential in this field. AI excels at analysing vast data sources, leading to improved detection of subtle safety signals and emerging drug safety concerns. Additionally, AI-powered risk prediction allows for personalized treatment strategies, minimizing adverse drug reactions for individual patients. Furthermore, AI facilitates efficient literature mining and drug repurposing, accelerating drug discovery processes. While the potential benefits are significant, responsible implementation is crucial. Addressing potential biases in algorithms and ensuring data privacy and security remain critical considerations. Overall, AI holds immense promise for the future of pharmacovigilance, paving the way for a more efficient, accurate, and proactive system for safeguarding patient well-being.

Assessment of the State of Pharmacovigilance in Secondary Hospitals in the Federal Capital Territory of Nigeria, Using WHO Pharmacovigilance Indicators.

The importance of pharmacovigilance (PV) in ensuring drug safety, especially in the detection and prevention of adverse drug reactions (ADRs) is critical. However, PV activities in Nigeria still face many challenges, such as very low spontaneous reporting rates, and inadequate training and funding. This study assessed the state of pharmacovigilance in the federal capital territory of Nigeria (FCT), using WHO pharmacovigilance indicators. A cross-sectional questionnaire-based survey was carried out among secondary healthcare facilities in the FCT. The WHO Pharmacovigilance Indicators Questionnaire, which consists of the structural, process and outcome measures, was used to collect data from the focal person for pharmacovigilance at all the consenting facilities. Descriptive statistics were used to summarize all variables. Ethical approval was obtained from the Ethics Review Committee of the FCT development authority. Of the 14 secondary healthcare facilities in the FCT, 11 agreed to the study (response rate = 84.6%). Among the respondents, 4 (36.4%) were females, and 2 (18.2%) had 9 years of experience in pharmacovigilance. For the core structural indicators, 7 (63.6%) of the facilities had a pharmacovigilance center while only 4 (36.4%) had a copy of the Nigerian pharmacovigilance policy. Regarding financial provisions, 10 (90.9%) hospitals reported that there was no regular financial provision for the center while 10 (90.9%) centers had a standard adverse drug reaction reporting form. For the core process indicators, the mean ± SD of the nine core process indicators ranged from 0.9 ± 3.0 to 75.6 ± 38.6 and the total number of reports in the local database, therapeutic ineffectiveness, and medication error were limited. The assessment of pharmacovigilance activities in the Federal Capital Territory of Nigeria revealed significant gaps in infrastructure, financial support, and process implementation. Despite the presence of pharmacovigilance centers in the majority of facilities, the lack of consistent financial support and limited adherence to core process indicators highlight the need for enhanced training, resources, and policy enforcement to improve ADR reporting and overall drug safety monitoring. Strengthening these areas is crucial for advancing pharmacovigilance practices and ensuring patient safety in Nigeria.

Innovations in Pharmacovigilance: Leveraging Artificial Intelligence for Enhanced Drug Safety Monitoring

The technique of pharmacovigilance, which involves keeping an eye on how medical pharmaceuticals are working after they've been approved for use, is vital in making sure that drugs are safe to use. Novel approaches brought about by the advent of Artificial Intelligence (AI) have the potential to greatly improve pharmacovigilance by making ADR identification, evaluation, and prevention much more effective. This study delves into the most recent advancements in AI-driven pharmacovigilance, shedding light on how drug safety monitoring is being revolutionised by machine learning algorithms, natural language processing, and big data analytics. In this article, we will go over the pros, cons, and possible next steps for pharmacovigilance frameworks that use AI.

Short-Term Training, a Useful Approach for Sustainable Pharmacovigilance Knowledge Development in Tanzania, Kenya, Ethiopia and Rwanda.

Continuous professional development among stakeholders involved in drug safety monitoring and surveillance is imperative in strengthening pharmacovigilance (PV) systems. The "Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa" (PROFORMA) project aims to enhance the national PV infrastructure, post-marketing surveillance systems and clinical trial regulatory capabilities in Ethiopia, Tanzania, Kenya and Rwanda. To achieve this, training, including short-term training (STT) activities, at various levels is required. This article aims to describe the experiences of the authors during the development and implementation of STT in an attempt to improve the PV training landscape of these countries. To identify gaps, a baseline assessment of PV teaching and practices at the national medicines regulatory authorities (NMRAs) and medical universities was conducted. Five successive training sessions, tailored to each country's specific needs and regulatory environments, were conducted; three focusing on fundamental concepts in PV and two dedicated to training-of-trainers courses. The training targeted staff from PV units of the NMRAs and medical universities. Enabling participation from all four countries in the same training fostered cross-country learning and collaboration. The contribution of STT to university education and the operational methodologies within NMRAs are explored, showcasing the impact on knowledge transfer and skill development in each country. In conclusion, by investing strategically in STT activities and fostering partnerships with academic institutions and NMRAs, we demonstrated a sustainable approach to PV capacity strengthening in resource-limited settings. The success of this model underscores its potential for adoption and replication across the African continent, offering a valuable framework for strengthening drug safety regulation and ultimately protecting public health.

An online evidence-based dictionary of common adverse events of antidepressants: a new tool to empower patients and clinicians in their shared decision-making process

BackgroundAdverse events (AEs) are commonly reported in clinical studies using the Medical Dictionary for Regulatory Activities (MedDRA), an international standard for drug safety monitoring. However, the technical language of MedDRA makes it challenging for patients and clinicians to share understanding and therefore to make shared decisions about medical interventions. In this project, people with lived experience of depression and antidepressant treatment worked with clinicians and researchers to co-design an online dictionary of AEs associated with antidepressants, taking into account its ease of use and applicability to real-world settings.MethodsThrough a pre-defined literature search, we identified MedDRA-coded AEs from randomised controlled trials of antidepressants used in the treatment of depression. In collaboration with the McPin Foundation, four co-design workshops with a lived experience advisory panel (LEAP) and one independent focus group (FG) were conducted to produce user-friendly translations of AE terms. Guiding principles for translation were co-designed with McPin/LEAP members and defined before the finalisation of Clinical Codes (CCs, or non-technical terms to represent specific AE concepts). FG results were thematically analysed using the Framework Method.ResultsStarting from 522 trials identified by the search, 736 MedDRA-coded AE terms were translated into 187 CCs, which balanced key factors identified as important to the LEAP and FG (namely, breadth, specificity, generalisability, patient-understandability and acceptability). Work with the LEAP showed that a user-friendly language of AEs should aim to mitigate stigma, acknowledge the multiple levels of comprehension in ‘lay’ language and balance the need for semantic accuracy with user-friendliness. Guided by these principles, an online dictionary of AEs was co-designed and made freely available (https://thesymptomglossary.com). The digital tool was perceived by the LEAP and FG as a resource which could feasibly improve antidepressant treatment by facilitating the accurate, meaningful expression of preferences about potential harms through a shared decision-making process.ConclusionsThis dictionary was developed in English around AEs from antidepressants in depression but it can be adapted to different languages and cultural contexts, and can also become a model for other interventions and disorders (i.e., antipsychotics in schizophrenia). Co-designed digital resources may improve the patient experience by helping to deliver personalised information on potential benefits and harms in an evidence-based, preference-sensitive way.

Real-World Safety Profile of Biologic Drugs for Severe Uncontrolled Asthma: A Descriptive Analysis from the Spanish Pharmacovigilance Database.

Background: The present investigation provides a thorough analysis of adverse drug reactions (ADRs) reported in the Database of the Spanish Pharmacovigilance System (FEDRA) for biologic medications primarily indicated for severe refractory asthma, including omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab. Our main objective was to identify ADRs not documented in the drugs' Technical Sheets (summary of product characteristics, SmPC), potentially indicating unrecognized risks meriting pharmacovigilance attention. Methods: Data spanning from each drug's market introduction until 22 January 2024, were analyzed, sourced from direct submissions to the Spanish Pharmacovigilance System, industry communications, and literature reviews. We evaluated notifications impartially to ensure a comprehensive review of all the ADRs associated with these medications. Results: This investigation underlines the critical role of post-marketing surveillance in enhancing patient safety. It emphasizes the necessity for healthcare professionals to report ADRs comprehensively to foster a robust pharmacovigilance system. Furthermore, the study highlights gaps between the reported ADRs and the information provided in SmPCs, signaling potential areas for improvement in drug safety monitoring and regulatory oversight. Conclusions: Finally, these findings may contribute to informed decision making in clinical practice and regulatory policy, ultimately advancing patient care and safety in the management of severe uncontrolled asthma.

Aspect-based drug review classification through a hybrid model with ant colony optimization using deep learning

The task of aspect-level sentiment analysis is intricately designed to determine the sentiment polarity directed towards a specific target within a sentence. With the increasing availability of online reviews and the growing importance of healthcare decisions, analyzing drug reviews has become a critical task. Traditional sentiment analysis, which categorizes a whole review as positive, negative, or neutral, provides limited insights for consumers and healthcare professionals. Aspect-based sentiment analysis (ABSA) aims to overcome these limitations by identifying and evaluating the sentiment associated with specific aspects or attributes of drugs mentioned in the reviews. Various fields, including business, politics, and medicine, have been explored in the context of sentiment analysis. Automation of online user reviews allows pharmaceutical companies to assess large amounts of user feedback. This helps extract pharmacological efficacy and side effect insights. The data collected could improve pharmacovigilance. Reviewing user comments can provide valuable data that can be used to improve drug safety and efficacy monitoring procedures. This improves pharmacovigilance processes, improving pharmaceutical outcomes understanding and corporate decision-making. Therefore, we propose a pre-trained RoBERTa with a Bi-LSTM model to categorise drug reviews from online sources and pre-process the text data. Ant Colony Optimization can be used in feature selection for ABSA, helping to identify the most relevant aspects and sentiments. Further, RoBERTa is fine-tuned to perform ABSA on the dataset, enabling the system to categorize aspects and determine the associated sentiment. The outcomes reveal that the suggested framework has achieved higher accuracy (96.78%) and F1 score (98.29%) on druglib.com, and 95.02% on the drugs.com dataset, than several prior state-of-the-art methods.

Empowering Pharmacovigilance: The Role of Web 3.0 Technologies in Enhancing Drug Safety and Patient Engagement

The rise of Web 3.0 technology suggests excellent progress in many fields, like healthcare. In this study, we explored the possible impact that Web 3.0 could have on reducing significant drug side effects among patients, which is an ongoing problem in pharmacotherapy. We looked at how often and in what ways adverse reactions to medication occur by analyzing a full dataset containing all drugs' alternatives as well as their corresponding effects, uses and classifications. Our method includes examining data and knowledge about decentralized data handling, safety, and approaches that focus on users in Web 3.0. The results indicate how much better drug safety monitoring can be achieved through decentralized applications, smart contracts, and blockchain technology. It also shows the potential to make patient therapy more personal and motivate patient education and involvement in healthcare decisions. This study emphasizes the ability of Web 3.0 to transform the monitoring of drug safety and effectiveness; it presents a strong case for its use within healthcare systems. The ideas for doctors, patients and healthcare policymakers highlight the crucial need to include Web 3.0 technology to improve patient results and reduce drug-linked morbidity along with death rates.

Pharmacovigilance: A Necessary Tool for Drug Safety Monitoring Globally

Pharmacovigilance, which is like a parasol to define the procedures for monitoring and analysing adverse drug reactions (ADRs), is a crucial part of efficient clinical practise, public health initiatives, and drug control systems. The volume of data processed has increased as a result of the rise in reported adverse drug reactions (ADRs), and understanding pharmacovigilance requires a high degree of skill in order to quickly identify medication hazards and defend the product against an unwarranted removal. An impartial method of evaluation would strengthen the present global network of pharmacovigilance centres, which is managed by the Uppsala Monitoring Centre. This would take into account contentious and significant medication safety problems that might have a negative impact on public health across international borders. Pharmacovigilance has recently focused mostly on identifying previously unrecognised or poorly understood adverse medication occurrences. Pharmacovigilance is a crucial and essential component of clinical research, and it is now expanding in many nations. However, with the turn of the millennium, pharmacovigilance confronts enormous hurdles in aspect of improving safety and monitoring of medications. Today, several pharmacovigilance centres are engaged for drug safety monitoring in this global arena. In this overview, we'll talk about medication safety, the function of international pharmacovigilance centres, the advantages and drawbacks of pharmacovigilance, and how it may be used in the future by the healthcare industry.
 Keywords: Drug safety, Adverse drug reaction, Drug Monitoring, Erice declaration, pharmacovigilance

Layer-Weighted Attention and Ascending Feature Selection: An Approach for Seriousness Level Prediction Using the FDA Adverse Event Reporting System

In this study, we introduce a novel combination of layer-static-weighted attention and ascending feature selection techniques to predict the seriousness level of adverse drug events using the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). We utilized natural language processing (NLP) to analyze the terms in the active substance field, in addition to considering demographic and event information such as patient sex, healthcare provider qualification, and drug characterization. Our ascending feature selection method, which progressively incorporates additional features based on their importance, demonstrated continuous enhancements in prediction performance. Simultaneously, we employed a layer-static-weighted attention technique, which dynamically adjusts the model’s focus between natural language processing (NLP) and demographic features. This technique achieved its best performance at a balanced weight of 50%, yielding an average test accuracy of 74.56% and CV ROC score of 0.83 when 4000 features were included, indicating a compelling advantage to include a larger volume of meaningful features. By integrating these methodologies, we constructed a robust model capable of effectively predicting seriousness levels, offering significant potential for improving pharmacovigilance and enhancing drug safety monitoring. The results underscore the value of NLP and demographic data in predicting drug event seriousness and demonstrate the effectiveness of our combined techniques. We encourage further research to refine these methods and evaluate their application to other clinical datasets.

OpenSAFELY: The impact of COVID-19 on azathioprine, leflunomide and methotrexate monitoring, and factors associated with change in monitoring rate.

The COVID-19 pandemic created unprecedented pressure on healthcare services. This study investigates whether disease-modifying antirheumatic drug (DMARD) safety monitoring was affected during the COVID-19 pandemic. A population-based cohort study was conducted using the OpenSAFELY platform to access electronic health record data from 24.2 million patients registered at general practices using TPP's SystmOne software. Patients were included for further analysis if prescribed azathioprine, leflunomide or methotrexate between November 2019 and July 2022. Outcomes were assessed as monthly trends and variation between various sociodemographic and clinical groups for adherence with standard safety monitoring recommendations. An acute increase in the rate of missed monitoring occurred across the study population (+12.4 percentage points) when lockdown measures were implemented in March 2020. This increase was more pronounced for some patient groups (70-79 year-olds: +13.7 percentage points; females: +12.8 percentage points), regions (North West: +17.0 percentage points), medications (leflunomide: +20.7 percentage points) and monitoring tests (blood pressure: +24.5 percentage points). Missed monitoring rates decreased substantially for all groups by July 2022. Consistent differences were observed in overall missed monitoring rates between several groups throughout the study. DMARD monitoring rates temporarily deteriorated during the COVID-19 pandemic. Deterioration coincided with the onset of lockdown measures, with monitoring rates recovering rapidly as lockdown measures were eased. Differences observed in monitoring rates between medications, tests, regions and patient groups highlight opportunities to tackle potential inequalities in the provision or uptake of monitoring services. Further research should evaluate the causes of the differences identified between groups.

The Increasing Demand for Skilled Professionals in the Field of Pharmacovigilance

ABSTRACT The pharmaceutical sector is experiencing rapid advancements in drug discovery, strict regulations, and a commitment to patient safety. This has led to an increased demand for skilled pharmacovigilance experts who can ensure the safety and effectiveness of medicinal products. Several factors contribute to this demand. The expanding pharmaceutical landscape leads to the need for thorough investigation of the safety profile of new medications and treatments. The increasing volume of pharmaceutical products also requires close monitoring for safety and efficacy. Strict regulatory requirements from global agencies further emphasize the need for a robust pharmacovigilance system. The industry’s focus on patient safety drives the demand for professionals who can effectively manage and analyze safety data. The rise of biologics and biosimilars presents additional challenges in monitoring and assessing safety profiles, creating a need for specialized expertise. Furthermore, the globalization of clinical trials and technological advancements, such as artificial intelligence (AI) and machine learning (ML), require experts who can integrate these tools into pharmacovigilance methods. There are certain skill sets that are crucial for pharmacovigilance professionals. These include regulatory knowledge, data analysis and interpretation, case processing, signal detection and risk management, medical and scientific expertise, communication skills, and technological proficiency. There are various career opportunities in pharmacovigilance, including pharmacovigilance officer, pharmacovigilance scientist, medical reviewer, pharmacovigilance team lead/manager, regulatory affairs specialist, and consultant and trainer. Future trends in the field include the convergence of AI and ML, the use of real-world evidence for postmarketing surveillance and drug safety monitoring, collaboration, and outsourcing for PV projects, and the need to tailor pharmacovigilance approaches to personalized medicine. In conclusion, the pharmaceutical industry’s evolution and commitment to patient safety have created a growing need for skilled professionals in pharmacovigilance. Investments in the development and education of these professionals are essential for the advancement of drug safety and public health.

Navigating duplication in pharmacovigilance databases: a scoping review

ObjectivesPharmacovigilance databases play a critical role in monitoring drug safety. The duplication of reports in pharmacovigilance databases, however, undermines their data integrity. This scoping review sought to provide a comprehensive...

Unveiling the future: precision pharmacovigilance in the era of personalized medicine

In the era of personalized medicine, pharmacovigilance faces new challenges and opportunities, demanding a shift from traditional approaches. This article delves into the evolving landscape of drug safety monitoring in the context of personalized treatments. We aim to provide a succinct reflection on the intersection of tailored therapeutic strategies and vigilant pharmacovigilance practices. We discuss the integration of pharmacogenetics in enhancing drug safety, illustrating how genetic profiling aids in predicting drug responses and adverse reactions. Emphasizing the importance of phase IV—post-marketing surveillance, we explore the limitations of pre-marketing trials and the necessity for a comprehensive approach to drug safety. The article discusses the pivotal role of pharmacogenetics in pre-exposure risk management and the redefinition of pharmacoepidemiological methods for post-exposure surveillance. We highlight the significance of integrating patient-specific genetic profiles in creating personalized medication leaflets and the use of advanced computational methods in data analysis. Additionally, we examine the ethical, privacy, and data security challenges inherent in precision medicine, emphasizing their implications for patient consent and data management.

Enhancing pharmacovigilance for robust drug safety monitoring: addressing underreporting and collaborative solutions.

Enhancing pharmacovigilance for robust drug safety monitoring: addressing underreporting and collaborative solutions.

Diverse pharmacovigilance jurisdiction-The right way for global drug safety?

The purpose of this narrative review is to provide a comparison of several countries with different legislation and approaches to pharmacovigilance and to point out how these impact the number of adverse drug reactions (ADRs) that are reported to national competent authorities. Legislative and statistical data regarding ADR reporting from various national competent authorities' websites, databases, and pharmacovigilance centers were used. In combination with the WHO pharmacovigilance quantitative indicator that was applied to evaluate the effectiveness of particular national pharmacovigilance systems in our scope. The study compared pharmacovigilance systems in six countries, focusing on ADR reporting from 2010 onwards. All countries required MAHs to report ADRs, while healthcare professionals' obligations varied. Per-capita ADR reports increased in all countries with available data, with the United States having a significantly higher reporting rate, possibly due to FDA campaigns. Despite starting later, China's per-capita reporting rate surpassed that of the Czech Republic and Japan. The study highlighted various measures taken by countries to enhance ADR reporting systems since the inception of their programs, contributing to the overall increase in reporting rates. ADR reporting is a global priority, with efforts made by different countries to strengthen their pharmacovigilance systems. Some success can be seen in gradually improving per-capita ADR reporting rates. The varying reporting rates and measures taken by each country may serve as a basis for further research and exchange of best practices to improve drug safety monitoring worldwide.

CiteSpace Visual Analysis of Community Pharmacy Services in China: Bridging Local Insights and Global Trends

Purpose: This research traces the history of pharmacy services research in Chinese pharmacies over the past twenty years and attempts to identify key trends and hotspots consistent with global practices. Methodology: From January 2002 to December 2022, we leveraged databases such as CNKI, VIP, and Wanfang and deployed CiteSpace 5.8.R3 to visualize publication trends, authorship, and institutional contributions within the field. Results: Our synthesis highlights critical developments in drug safety monitoring, prescription management, pharmacoeconomics, and public health education and highlights the leadership of respected researchers and institutions. Conclusion: The “Internet+” paradigm is identified as an important catalyst for pharmacy services innovation, with implications that extend beyond China and suggest models for international adaptation and strategy development.

A Statistical Analysis of Sentiment over Different Social Platforms on Drug Usage across High, Middle and Low-Income Countries

Social media serves as a platform for sharing information and connecting with others on various subjects, including healthcare and drugs. Analyzing drug sentiment from various social media like Twitter, reddit, quora etc are crucial for monitoring drug safety, identifying adverse reactions, and providing an early warning system for potential safety concerns, benefiting healthcare organizations and governments. This paper aims to study the opinions of people from all over the world by analyzing their messages, posts on social media. For this study 39,069 drug related message corpus were fetched making a comparison between the high income countries, and middle income and low income countries on the basis of drug consumption from 2021 to 2023. The dataset used for the study consisted of 41.63% text-corpus from high income countries out of which on an average from 2021 to 2023, 40.2% was found to have a positive sentiment. Whereas 34.65% of text-corpus are from middle-income countries out of which on an average 26.4% of was of a positive sentiment and 23.70% text-corpus are from low income countries with 23.6% having a positive sentiment. Furthermore, the primary factor for having such differences from people’s sentiment on drug consumption from high to low income countries includes Cultural and Social Norms, Legalization, availability etc therefore, In high-income countries, drug use is more socially accepted than in other regions. This proposed study gives an insight into people’s opinion on various drugs from different countries and regions. The results of this study attempted to understand how the public is responding to different types of information and to identify potential misinformation which can be used to formulate policies for existing and future drug prevention campaigns in order to improve public health and promote public education.

Anaphylaxis in Clinical Trials of Sublingual Immunotherapy Tablets

There is no consensus method to identify anaphylaxis in sublingual immunotherapy (SLIT) trials. Standardized Medical Dictionary for Regulatory Activities (MedDRA) queries (SMQs) are standardized groupings of MedDRA terms used in drug safety monitoring. To develop a method to identify potential anaphylaxis in SLIT-tablet trials using SMQ searches and case definitions of anaphylaxis adopted from the National Institute of Allergy and Infectious Disease. The SMQ search tool contained 2 criteria including treatment-emergent adverse events (AEs): (1) narrow MedDRA terms related to anaphylaxis and (2) all AEs with broad MedDRA terms from at least 2 of 3 categories (respiratory/skin/cardiovascular) occurring on the same day. Criteria were applied to a pooled data set of all subjects from 48 timothy grass, ragweed, house dust mite, and tree SLIT-tablet trials (SLIT-tablet, N= 8200; placebo, N= 7033). Additional search strategies were any treatment-emergent AE with MedDRA preferred term "hypersensitivity" and epinephrine administrations. Identified potential cases underwent blinded independent medical expert review. Nonanaphylaxis cases were designated local AEs or mild to moderate systemic reactions. Using the SMQ search tool and after subsequent medical review, 8 anaphylaxis cases were identified; 3 were considered treatment-related, resulting in a proportion of anaphylaxis cases/subject of 0.02% (2 of 8200) with SLIT-tablet and 0.01% (1 of 7033) with placebo. One additional anaphylaxis case related to SLIT-tablet was identified by the preferred term "hypersensitivity." The 3 anaphylaxis cases associated with SLIT-tablet treatment were not life-threatening. The epinephrine administration rate was 17 of 8200 (0.2%) with SLIT-tablet treatment and 2 of 7033 (0.03%) with placebo. SMQ search criteria for identifying potential anaphylaxis related to SLIT were developed. Anaphylaxis was rare for SLIT-tablets.