Gastroenterol Clin North Am. 2023 Sep;52(3):535-548. doi: 10.1016/j.gtc.2023.05.007. Epub 2023 Jun 7.

ABSTRACT

Therapeutic options for the treatment of pediatric inflammatory bowel disease include aminosalicylates, enteral nutrition, corticosteroids, immunomodulators, biologics, and emerging small molecule agents. Infectious risk due to systemic immunosuppression should be mitigated by appropriate screening before therapy initiation. Rare but serious malignancies have been associated with thiopurine use alone and in combination with anti-tumor necrosis factor agents, often in the setting of a primary Epstein-Barr virus infection. Potential agent-specific adverse events such as cytopenias, hepatotoxicity, and nephrotoxicity warrant regular clinical and laboratory monitoring.

PMID:37543398 | DOI:10.1016/j.gtc.2023.05.007

BMC Pharmacol Toxicol. 2023 Aug 4;24(1):41. doi: 10.1186/s40360-023-00681-y.

ABSTRACT

BACKGROUND: drug overdose is a common type of medication error, which caused significant patient injuries and economic losses. To determine which drugs are reported most frequently in association with drug overdose, a comprehensive search was conducted in the FDA Adverse Event Reporting System (FAERS) database. The study also sought to determine the top 10 drugs reported with drug overdose.

METHODS: FAERS database was searched for drug overdose records submitted from the first quarter of 2017 to the fourth quarter of 2021. Descriptive analyses were conducted based on the total counts and percentages of reports associated with the drug. Subgroup analyses were performed on drugs of different pharmacological classifications.

RESULTS: A total of 170,424 drug overdose reports were retrieved. The results revealed that antipyretics and analgesics took the highest risk for overdose, with 63,143 (37.05%) cases reported. Among them, opioids were associated with the most drug overdose events. The top 10 drug classes relating to drug overdose in FAERS were opioid analgesic, anilide antipyretic analgesic, 5-HT reuptake inhibitors, bronchodilators, monoclonal antibodies and antibody-drug conjugates, benzodiazepines, antipsychotics, GABA derivatives, antimanic agents, and propionic acid derivatives.

CONCLUSION: to reduce the occurrence of drug overdose events, some methods could be considered including applying a pre-prescription review system, drug safety education, developing warning lists, etc.

PMID:37542326 | PMC:PMC10403938 | DOI:10.1186/s40360-023-00681-y

Eur J Hosp Pharm. 2023 Aug 4:ejhpharm-2023-003929. doi: 10.1136/ejhpharm-2023-003929. Online ahead of print.

NO ABSTRACT

PMID:37541777 | DOI:10.1136/ejhpharm-2023-003929

Med Mycol. 2023 Aug 2;61(8):myad079. doi: 10.1093/mmy/myad079.

ABSTRACT

Posaconazole therapeutic drug monitoring (TDM) is widely utilized to assess therapeutic efficacy and safety; however, clinical effects of very high serum concentrations are unknown. A retrospective review of 90 patients receiving posaconazole for treatment or prophylaxis of invasive fungal infections with serum concentrations ≥3000 ng/mL from 1/1/2019 to 4/30/2021 evaluated the incidence and type of adverse drug reactions (ADRs). Symptomatic ADRs were very common in patients with posaconazole concentrations of ≥5000 ng/mL and 3000-4999 ng/mL (80% vs. 58.8%; P = 0.31). Posaconazole TDM should be performed for both treatment and prophylaxis indications and dose decrease for serum concentrations >3000 ng/mL should be considered.

PMID:37537152 | PMC:PMC10414342 | DOI:10.1093/mmy/myad079

Science. 2023 Aug 4;381(6657):466-467. doi: 10.1126/science.adk0830. Epub 2023 Aug 3.

ABSTRACT

Despite landmark antibody approval, research into brain swelling and bleeding lags.

PMID:37535727 | DOI:10.1126/science.adk0830

Drug Ther Bull. 2023 Aug 3:dtb-2023-000041. doi: 10.1136/dtb.2023.000041. Online ahead of print.

NO ABSTRACT

PMID:37536751 | DOI:10.1136/dtb.2023.000041

Drug Ther Bull. 2023 Aug 3:dtb-2023-000042. doi: 10.1136/dtb.2023.000042. Online ahead of print.

NO ABSTRACT

PMID:37536750 | DOI:10.1136/dtb.2023.000042

BMC Med Inform Decis Mak. 2023 Aug 3;23(1):148. doi: 10.1186/s12911-023-02248-7.

ABSTRACT

BACKGROUND: High-dose methotrexate (HD-MTX) is a potent chemotherapeutic agent used to treat pediatric acute lymphoblastic leukemia (ALL). HD-MTX is known for cause delayed elimination and drug-related adverse events. Therefore, close monitoring of delayed MTX elimination in ALL patients is essential.

OBJECTIVE: This study aimed to identify the risk factors associated with delayed MTX elimination and to develop a predictive tool for its occurrence.

METHODS: Patients who received MTX chemotherapy during hospitalization were selected for inclusion in our study. Univariate and least absolute shrinkage and selection operator (LASSO) methods were used to screen for relevant features. Then four machine learning (ML) algorithms were used to construct prediction model in different sampling method. Furthermore, the performance of the model was evaluated using several indicators. Finally, the optimal model was deployed on a web page to create a visual prediction tool.

RESULTS: The study included 329 patients with delayed MTX elimination and 1400 patients without delayed MTX elimination who met the inclusion criteria. Univariate and LASSO regression analysis identified eleven predictors, including age, weight, creatinine, uric acid, total bilirubin, albumin, white blood cell count, hemoglobin, prothrombin time, immunological classification, and co-medication with omeprazole. The XGBoost algorithm with SMOTE exhibited AUROC of 0.897, AUPR of 0.729, sensitivity of 0.808, specificity of 0.847, outperforming the other models. And had AUROC of 0.788 in external validation.

CONCLUSION: The XGBoost algorithm provides superior performance in predicting the delayed elimination of MTX. We have created a prediction tool to assist medical professionals in predicting MTX metabolic delay.

PMID:37537590 | DOI:10.1186/s12911-023-02248-7

Fam Pract. 2023 Aug 3:cmad080. doi: 10.1093/fampra/cmad080. Online ahead of print.

ABSTRACT

BACKGROUND: Musculoskeletal corticosteroid injection (CSI) is a frequently used treatment, considered safe with a low incidence of minor side effects.

OBJECTIVE: To investigate whether the incidence of acute coronary syndrome (ACS) is increased following corticosteroid injection for musculoskeletal conditions.

METHODS: Data were reviewed from 41,276 patients aged over 40 years and hospitalised with ACS between January 2015 and December 2019. Each ACS case was allocated up to 10 control patients from their primary care clinic, matched for age and sex. The cases and controls were reviewed for orthopaedic or rheumatological consultation including a CSI procedure and occurring prior to the hospital admission date. The incidence of CSI was compared between the case and control groups.

RESULTS: Data from a total of 413,063 patients were reviewed, 41,276 ACS cases and 371,787 controls. The mean age was 68.1, standard deviation (SD) = 13.1, 69.4% male. In the week prior to their hospital admission, 118 ACS patients were treated with CSI compared with 495 patients in the control group; odds ratio (OR) = 1.95 (1.56-2.43). In total, 98% of CSI procedures were carried out by orthopaedic specialists. An association between ACS and prior CSI was strongest in the days immediately prior to hospitalisation: OR = 3.11 (2.10-4.61) for patients who were injected 1 day before ACS. The association between ACS and CSI declined with increasing time between injection and hospital admission: at 90 days OR = 1.08 (0.98-1.18). The association remained robust when cardiovascular risk factors, history of rheumatological disease, and other co-morbidity were taken into consideration.

CONCLUSIONS: Musculoskeletal corticosteroid injection appears to substantially increase the risk of acute coronary syndrome.

PMID:37535976 | DOI:10.1093/fampra/cmad080

Neurol Res Pract. 2023 Aug 3;5(1):41. doi: 10.1186/s42466-023-00265-5.

ABSTRACT

BACKGROUND: Assessment of quality of life (QoL) has become an important indicator for chronic neurological diseases. While these conditions often limit personal independence and autonomy, they are also associated with treatment-related problems and reduced life expectancy. Epilepsy has a tremendous impact on the QoL of patients and their families, which is often underestimated by practitioners. The aim of this work was to identify relevant factors affecting QoL in adults with epilepsy.

METHODS: This cross-sectional, multicenter study was conducted at four specialized epilepsy centers in Germany. Patients diagnosed with epilepsy completed a standardized questionnaire focusing on QoL and aspects of healthcare in epilepsy. Univariate regression analyses and pairwise comparisons were performed to identify variables of decreased QoL represented by the overall Quality of Life in Epilepsy Inventory (QOLIE-31) score. The variables were then considered in a multivariate regression analysis after multicollinearity analysis.

RESULTS: Complete datasets for the QOLIE-31 were available for 476 patients (279 [58.6%] female, 197 [41.4%] male, mean age 40.3 years [range 18-83 years]). Multivariate regression analysis revealed significant associations between low QoL and a high score on the Liverpool Adverse Events Profile (LAEP; beta=-0.28, p < 0.001), Hospital Anxiety and Depression Scale - depression subscale (HADS-D; beta=-0.27, p < 0.001), Neurological Disorders Depression Inventory in Epilepsy (NDDI-E; beta=-0.19, p < 0.001), revised Epilepsy Stigma Scale (beta=-0.09, p = 0.027), or Seizure Worry Scale (beta=-0.18, p < 0.001) and high seizure frequency (beta = 0.14, p < 0.001).

CONCLUSION: Epilepsy patients had reduced QoL, with a variety of associated factors. In addition to disease severity, as measured by seizure frequency, the patient's tolerability of anti-seizure medications and the presence of depression, stigma, and worry about new seizures were strongly associated with poor QoL. Diagnosed comorbid depression was underrepresented in the cohort; therefore, therapeutic decisions should always consider individual psychobehavioral and disease-specific aspects. Signs of drug-related adverse events, depression, fear, or stigmatization should be actively sought to ensure that patients receive personalized and optimized treatment.

TRIAL REGISTRATION: German Clinical Trials Register (DRKS00022024; Universal Trial Number: U1111-1252-5331).

PMID:37533112 | DOI:10.1186/s42466-023-00265-5

J Vet Sci. 2023 Jul;24(4):e59. doi: 10.4142/jvs.23002.

ABSTRACT

BACKGROUND: Rocuronium bromide has been evaluated as a mydriatic agent in birds, but the species applied were limited and the dose and effect were variable.

OBJECTIVE: This study aims to evaluate the efficacy of topical rocuronium bromide as mydriatics in 4 species according to horizontal palpebral fissure length: Feral pigeon (Columba livia), Common kestrel (Falco tinnunculus), Northern boobook (Ninox japonica), and Eurasian eagle owl (Bubo bubo).

METHODS: A total of 32 birds (8 for each species) were included as pre-releasing examination. Rocuronium bromide was instilled in one randomly selected eye of each bird based on palpebral fissure length criteria (0.5 mg/50 µL for pigeons, 1 mg/100 µL for kestrels and boobook owls, and 2 mg/200 µL for eagle owls). The contralateral eye was used as control and treated with normal saline. After instillation of the drug, pupil diameter, pupillary light reflex, intraocular pressure, heart rate, and respiratory rate were evaluated at 10 min intervals up to 180 min and at 30 min intervals up to 360 min.

RESULTS: Statistically significant mydriasis was obtained in all birds (p < 0.001). However, in boobook and eagle owls, marked mydriasis persisted until 360 min. Side effects including corneal erosion and lower eyelid paralysis were common, which was observed in 26/32 birds. Blepharospasm was also noted during this study. No systemic adverse signs were observed.

CONCLUSIONS: Rocuronium bromide could be a good mydriatics option for 4 species of birds, however, further studies are needed to find lowest effective dose to reduce drug-related side effects.

PMID:37532302 | DOI:10.4142/jvs.23002

JAMA Dermatol. 2023 Aug 2. doi: 10.1001/jamadermatol.2023.2428. Online ahead of print.

ABSTRACT

IMPORTANCE: Dupilumab is a theoretically novel therapy for bullous pemphigoid (BP). However, its effectiveness and safety have yet to be confirmed in a large-scale study.

OBJECTIVE: To assess the efficacy and safety of dupilumab in patients with BP and evaluate factors that potentially affect short-term and long-term outcomes.

DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study was conducted from January 1, 2021, to July 31, 2022. The median (IQR) follow-up period was 24.6 (11.5-38.4) weeks. This multicenter study was performed in 6 dermatology departments of the National Autoimmune Bullous Diseases Cooperative Group of China. Adult patients with BP that received 300 mg of dupilumab every 2 weeks following an initial dose of 600 mg were included. Patients were eligible if they had a clinical presentation of BP combined with immunological or pathological evidence. Patients with drug-induced BP, with less than 4 weeks of follow-up, and who received dupilumab or any other biologics within 6 months were excluded.

MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of patients who achieved disease control within 4 weeks. Disease control was defined as the absence of new lesions and pruritus, combined with the healing of existing lesions. Complete remission rates, relapse rates, changes in Bullous Pemphigoid Disease Area Index (BPDAI) scores, itching numerical rating scale (NRS) scores, laboratory results within 64 weeks, and adverse events (AEs) were also assessed.

RESULTS: Among 146 patients (median [IQR] age, 73 [64-85] years; 86 [58.9%] male patients) included in the study, 127 (87.0%) patients achieved disease control within 4 weeks, with a median (IQR) time of 14 (7-14) days. A total of 52 (35.6%) patients achieved complete remission, and 13 (8.9%) patients relapsed during the observation period. The complete remission rate and cumulative relapse rate at week 64 were 62.5% (5 of 8) and 30.9%, respectively. There was rapid and sustained improvement in clinical indicators and laboratory examination results after dupilumab treatment, including BPDAI scores, itching NRS scores, serum anti-BP180 and anti-BP230 antibodies, total IgE levels, and eosinophil count. Of these 146 patients, 107 (73.3%) did not report any AEs. The most common AEs were infections and eosinophilia. Serum anti-BP180 antibody levels of greater than 50 relative units (RU)/mL (OR, 3.63; 95% CI, 0.97-12.61; P = .045) were associated with 4-week disease control, and male patients were more likely to relapse (HR, 10.97; 95% CI, 1.42-84.92; P = .02).

CONCLUSIONS AND RELEVANCE: In this retrospective cohort study, dupilumab treatment was associated with improved clinical symptoms in patients with BP. The safety profile was favorable, although concurrent infection and eosinophilia might pose potential concerns. This study suggests that patients with anti-BP180 antibody levels of at least 50 RU/mL and female sex may respond better.

PMID:37531116 | DOI:10.1001/jamadermatol.2023.2428

Immunotherapy. 2023 Sep;15(13):993-999. doi: 10.2217/imt-2022-0213. Epub 2023 Jul 31.

ABSTRACT

The overall survival of melanoma patients has improved using antibodies targeting immune checkpoints (anti-PD-1, anti-CTLA-4 and anti-LAG-3). Systemic chemotherapy was administered in melanoma for many years with limited effectiveness. Here we report a case of a patient who experienced immune-mediated adverse effects from checkpoint blockade therapy and subsequently responded to chemotherapy. The patient presented with melanoma and paraneoplastic digital ischemia. She received a combination of ipilimumab/nivolumab and experienced G3 myocarditis, followed by melanoma progression after a steroid taper. This patient achieved a partial and durable response with platinum and taxane-based chemotherapy. This report suggests the possibility of a subset of patients who experience progression after immune-based side effects where chemotherapy may be effective in the modern age of melanoma treatment.

PMID:37525573 | DOI:10.2217/imt-2022-0213

BMC Med Educ. 2023 Aug 1;23(1):547. doi: 10.1186/s12909-023-04542-4.

ABSTRACT

OBJECTIVES: To compare the pediatric neurologists' knowledge, practice, and barriers to the pharmacovigilance (PV) process in Poland and Germany.

METHODS: The research tool was an online anonymous questionnaire on Google Forms e-mailed to pediatric neurologists from Poland and Germany.

RESULTS: The questionnaires were handed out to 830 pediatric neurologists and 371 expressed their consent to participate in the study. Most of the neurologists were familiar with the definition of PV and adverse drug reactions (ADRs). Only 34.10% of pediatric neurologists from Poland, and 38.88% from Germany believe that many ADRs are preventable and almost most of them believe it is necessary to report ADRs from children with epilepsy. Unfortunately, in opposite to this knowledge, only 37.79% of respondents from Poland and 40.32% from Germany felt co-responsible for reporting ADRs. The main reason for the neurologists not to report ADRs was a conviction that reporting ADRs would be an additional burden generating extra work.

CONCLUSION: There is no big difference between the practice of PV by pediatric neurologists in Poland and Germany. System-regulated PV stabilization in the country translates into the practice of maintaining PV. Monitoring the safety of pharmacotherapy and knowledge of risks associated with ADRs should be included in the curricula of academic neurologics courses.

PMID:37528387 | PMC:PMC10394771 | DOI:10.1186/s12909-023-04542-4

J Korean Med Sci. 2023 Jul 31;38(30):e234. doi: 10.3346/jkms.2023.38.e234.

ABSTRACT

BACKGROUND: This study characterized coronavirus disease 2019 (COVID-19) vaccination behavior in the Korean general population using cluster analysis and explored related psychological factors.

METHODS: We categorized 1,500 individuals based on their attitudes toward COVID-19 vaccination using hierarchical clustering and identified their level of vaccine acceptance. We examined the associations between vaccine acceptance and behavioral and psychological characteristics.

RESULTS: Clustering revealed three groups according to vaccine acceptance: 'totally accepting' (n = 354, 23.6%), 'somewhat accepting' (n = 523, 34.9%), and 'reluctant' (n = 623, 41.5%). Approximately 60% of all participants who belonged to the 'totally accepting' and 'somewhat accepting' groups were willing to receive a COVID-19 vaccine despite concerns about its side effects. High vaccine acceptance was associated with older age, regular influenza vaccination, and trust in formal sources of information. Participants with high vaccine acceptance had higher levels of gratitude, extraversion, agreeableness, and conscientiousness, and lower levels of depression, anxiety, and neuroticism.

CONCLUSIONS: People weighed the benefits of COVID-19 vaccination against the risk of side effects when deciding to receive the COVID-19 vaccine. Our findings also indicate that this vaccination behavior may be affected by coping mechanisms and psychological factors.

PMID:37527911 | PMC:PMC10396430 | DOI:10.3346/jkms.2023.38.e234

Ann Med. 2023;55(2):2242248. doi: 10.1080/07853890.2023.2242248.

ABSTRACT

Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly utilized to reduce pain, inflammation, and fever. This study aimed to assess patterns of use and awareness of NSAID-related side-effects in an adult Jordanian. And the associations with sociodemographic factors. Methods: This cross-sectional study among a representative sample of 604 adults >18 years. A validated, self-administered questionnaire was used to collect basic sociodemographic data from the participants, as well as information regarding NSAID use. Results: Most respondents were NSAID users (65.7%), female (53.4%) and under 50 years of age (74.5%). Overall, 42.6% had been prescribed NSAIDs by a physician. Male gender and smoking were negatively correlated with NSAIDs use (multivariable odds ratio [OR]: 0.5, 95% confidence interval [CI]: 0.4-0.8, p = 0.001 and OR: 0.6, 95% CI 0.4-0.8, p = 0.003). In contrast, the Ministry of Health Insurance was associated with NSAIDs use with OR: 1.6, 95% CI: 1.1-2.6, p = 0.03. Overall, 65.1% were aware of kidney NSAID-related side-effects and 22.4% were aware of the increased risk of asthma and allergy. Conclusion: Despite the high frequency of NSAID use in the Jordanian general population, there is limited knowledge of their side-effects as well as drug interactions. This is cause for concern, particularly as many participants reported having been prescribed NSAIDs by physicians without adequate patient safety education.

PMID:37527416 | DOI:10.1080/07853890.2023.2242248

Geriatr Psychol Neuropsychiatr Vieil. 2023 Jun 1;21(2):214-220. doi: 10.1684/pnv.2023.1103.

ABSTRACT

INTRODUCTION: Inappropriate drug prescriptions (IP) lead to a high risk of adverse effects, especially for the elderly. Their detection is essential - which can be done using therapeutic lists, including the Stopp/Start scale version 2.

METHODS: Observational study - from August 1, 2016, to November 30, 2016, in an advanced geriatric unit at Rouen University Hospital - using the Stopp/Start version 2 list.

RESULTS: Eighty-five patients were included, with a ratio of 1.36 women per every man. Sixty-one patients (71.8%) had prescriptions for more than five drugs. The average Charlson comorbidity score was 6.05. One hundred ninety-one IPs were found. Classes E and G (kidney function and respiratory system prescriptions, respectively) were not uncovered. Fifty-four Stopp criteria - 66% of Stopp criteria - never emerged during our study. Using the 34 Start criteria, 187 omissions of prescriptions were found. Classes F and G (endocrine system and urogenital system drugs, respectively) were not observed at any time. Ten criteria were never seen (B3/C1/C4/C5/E6/E7/F1/G1/G2/G3). Nineteen criteria were mentioned less than three times - i.e., in approximately 10% of omissions.

CONCLUSION: Our study is part of an approach to protecting the elderly. A significant number of IP and prescription drug omissions were uncovered using this Stopp/Start version 2 tool.

PMID:37519079 | DOI:10.1684/pnv.2023.1103

Syst Rev. 2023 Jul 31;12(1):131. doi: 10.1186/s13643-023-02289-z.

ABSTRACT

BACKGROUND: Overviews (i.e., systematic reviews of systematic reviews, meta-reviews, umbrella reviews) are a relatively new type of evidence synthesis. Among others, one reason to conduct an overview is to investigate adverse events (AEs) associated with a healthcare intervention. Overviews aim to provide easily accessible information for healthcare decision-makers including clinicians. We aimed to evaluate the clinical utility of overviews investigating AEs.

METHODS: We used a sample of 27 overviews exclusively investigating drug-related adverse events published until 2021 identified in a prior project. We defined clinical utility as the extent to which overviews are perceived to be useful in clinical practice. Each included overview was assigned to one of seven pharmacological experts with expertise on the topic of the overview. The clinical utility and value of these overviews were determined using a self-developed assessment tool. This included four open-ended questions and a ranking of three clinical utility statements completed by clinicians. We calculated frequencies for the ranked clinical utility statements and coded the answers to the open-ended questions using an inductive approach.

RESULTS: The overall agreement with the provided statements was high. According to the assessments, 67% of the included overviews generated new knowledge. In 93% of the assessments, the overviews were found to add value to the existing literature. The overviews were rated as more useful than the individual included systematic reviews (SRs) in 85% of the assessments. The answers to the open-ended questions revealed two key aspects of clinical utility in the included overviews. Firstly, it was considered useful that they provide a summary of available evidence (e.g., along with additional assessments, or across different populations, or in different settings that have not been evaluated together in the included SRs). Secondly, it was found useful if overviews conducted a new meta-analysis to answer specific research questions that had not been answered previously.

CONCLUSIONS: Overviews on drug-related AEs are considered valuable for clinical practice by clinicians. They can make available evidence on AEs more accessible and provide a comprehensive view of available evidence. As the role of overviews evolves, investigations such as this can identify areas of value.

PMID:37525235 | DOI:10.1186/s13643-023-02289-z

Georgian Med News. 2023 Jun;(339):105-112.

ABSTRACT

Immunotherapy causes cancer patients' immune systems to activate in search of and eliminate cancer cells. As a therapeutic area for cancer, it has expanded in importance and demonstrated promising results in treating many cancers. Checkpoint blockade (CPB) therapy may stimulate a suppressed immune response to provide long-lasting therapeutic results. However, the absence of a tumor-reactive immune infiltration is probably why response rates are still low. Using chimeric antigen receptor (CAR)-modified T cells to fight cancer may significantly impact immunology. This study explored using checkpoint inhibitors, car-T cells, and vaccines in immunotherapy to treat cancers. Drugs used for CPB aim to reduce immunological suppression, allowing for more effective CAR T cells and dendritic cell (DC) vaccines, providing some optimism that this may be increased, both of which have proven therapeutic efficacy in specific cancers. However, drug-induced side effects and the tumor microenvironment's propensity for immunosuppression mean treatment effectiveness is still inadequate. The outcomes of current preclinical tests suggest that novel therapies targeting lymphocyte-activation gene 3 (LAG3), T cell immunoglobulin and mucin-domain containing-3 (TIM3), cytotoxic T lymphocyte-associated protein 4 (CTLA-4), and programmed cell death protein 1 (PD-1) could be used as adjuvant therapies to modify the tumor microenvironment.

PMID:37522784

Ann Pharmacother. 2023 Jul 31:10600280231189897. doi: 10.1177/10600280231189897. Online ahead of print.

ABSTRACT

BACKGROUND: Drug-induced immune hemolytic anemia (DIIHA) is a rare but potentially life-threatening pharmacogenic hematological adverse effect. Updating the risk of DIIHA among the currently available drugs based on spontaneously reported adverse event data is of great significance.

OBJECTIVE: This study aimed to identify the top 50 drugs associated with immune hemolytic anemia in adults as well as common drugs that could cause immune hemolytic anemia in children based on the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.

METHODS: We extracted adverse events (AE) in the FAERS database from Q1 2004 to Q3 2022 using Open vigil2.1. We use the high-level term "anaemias haemolytic immune" according to the Medical Dictionary for Regulatory Activities (MedDRA) Dictionary (version 24.0). The reported correlation between drugs and DIIHA risk was identified by reported odds ratio (ROR) and proportional reporting ratio (PRR).

RESULTS: There were 10500309 AEs in FAERS from 2004Q1 to 2022Q3, of which 2326 (0.02%) were DIIHA cases. The incidence of DIIHA is comparable between males and females. The most common drugs associated with DIIHA in adults and children are summarized according to the number of AE reports. The top 3 categories in terms of quantity of drugs are antineoplastic agents, immunosuppressants, and antibiotics for systemic use. The top 5 drugs in terms of ROR and PRR are alemtuzumab, daclizumab, fludarabine, busulfan, and bendamustine in adults, with entecavir, treosulfan, vinorelbine, pegademase, and alemtuzumab for children.

CONCLUSIONS: Our study identified the most common drugs that could induce DIIHA in adults and children, as well as the respective ROR and PRR value to discover new drug signals. This study provides references to clinicians for the management of rare DIIHA.

PMID:37522435 | DOI:10.1177/10600280231189897