Rare Adverse Effect Research Articles

Obinutuzumab-induced acute thrombocytopenia: a case report and literature review

BackgroundObinutuzumab, a humanized type II anti-CD20 monoclonal antibody, is widely used in the treatment of B-cell lymphomas. Thrombocytopenia typically occurs 1 to 2 weeks after administration. In rare cases, obinutuzumab can induce severe acute thrombocytopenia within days of infusion, a condition known as “obinutuzumab-induced acute thrombocytopenia (OIAT).” Rituximab, a chimeric type I anti-CD20 monoclonal antibody, is also known to cause “rituximab-induced acute thrombocytopenia (RIAT).” This report presents a case of OIAT, with subsequent treatment switched to rituximab, which did not result in thrombocytopenia recurrence.Case PresentationA 38-year-old female patient with a 2-year history of lymphadenopathy was diagnosed with follicular lymphoma (Grade I-II). She was treated with obinutuzumab combined with bendamustine. Following the first administration of obinutuzumab, her platelet count dropped to 37×10⁹/L within 2 days and further declined to 27×10⁹/L on the fourth day without bleeding symptoms. The platelet count recovered by day 8. After a second obinutuzumab infusion, the platelet count again dropped to 15×10⁹/L within 1 day. Platelet transfusion was effective, and the count eventually recovered to 95×10⁹/L by day 29. No further acute thrombocytopenia occurred after switching to rituximab.ConclusionOIAT is a rare but serious adverse effect of obinutuzumab. This case highlights the importance of early recognition and monitoring of platelet counts in patients receiving obinutuzumab. The findings in our case, along with those in the literature, suggest that switching to rituximab or extending the interval before obinutuzumab re-administration can reduce the risk of recurrent thrombocytopenia. Further research is needed to elucidate the underlying mechanisms and establish treatment guidelines for OIAT.

Sudden blurring of vision and micropsia following acute hot pepper consumption: A case report

Background: Retinal hemorrhages are typically considered a major ocular diagnostic sign of underlying systemic vascular disorder. Capsaicin is a bioactive component of chili peppers used in most countries. Capsaicin crosses the blood–brain barrier in an efficient manner. Exposure to dietary capsaicinoids is frequent and often considerable. The presumed lack of capsaicin toxicity in the diet does not rule out the possibility of rare adverse effects on the central nervous system, particularly the retina, as outlined in this report. Objective: The purpose of this case report is to describe the ocular issues occurring to a man who developed retinal hemorrhage following overconsumption of hot chili. Methods: A case of a 34-year-old man, who reported sudden blurring of vision and micropsia in his left eye following ingestion of a considerable amount of red pepper. Results: The case study suggests that acute or chronic consumption of substantial amounts of hot red pepper in individuals with high reactivity towards TRPV1 agonists and/or higher expression of TRPV1 receptors in retinal ganglion cells causes retinal neovascularization. Conclusion: Acute consumption of large amounts of red pepper in susceptible individuals may harm vision. Keywords: Capsaicin; Red Chili; Retinal hemorrhage; Optometry; Micropsia

Immune Checkpoint Inhibitor-Associated Celiac Disease: A Retrospective Analysis and Literature Review

Introduction: Immune checkpoint inhibitors (ICI) are used to treat various malignancies. They block the inhibitory signals of tumor cells and enhance the inflammatory cascade, which results in tumor killing. However, this can lead to unchecked inflammation throughout the body, leading to various adverse effects. A rare gastrointestinal adverse effect of ICI therapy is the development of immune-mediated celiac disease. This entity has a similar clinical presentation to the more common ICI-induced enterocolitis. Our study aims to determine the clinical characteristics and optimal treatment strategies for this rare ICI toxicity and differentiate it from ICI-induced enterocolitis. Methods and Material: We conducted a retrospective analysis of eight cases of ICI-induced celiac disease and 24 cases of ICI-induced enterocolitis from the literature. Data on patient demographics, clinical history, therapeutic interventions and outcomes were collected. A comparative analysis was performed to identify the key differences between the two groups. Results: Patients with ICI-induced celiac disease were more likely to have a pre-existing autoimmune condition and HLA-DQ2 positivity. Significant differences in clinical manifestations, histological findings, and treatment outcomes were observed. Notably, weight loss, nutritional deficiencies and electrolyte abnormalities were more commonly associated with ICI-induced celiac disease. Regarding pathology, duodenal villous blunting was noted more commonly with ICI-induced celiac disease. Initiating a gluten-free diet led to a rapid improvement in patients with ICI-induced celiac disease, while immunosuppressive therapy did not have an impact. Conclusion: ICI-induced celiac disease is a rare and underrecognized gastrointestinal adverse effect of ICI therapy, often misdiagnosed as ICI-induced enterocolitis. Early recognition and treatment with a gluten-free diet can lead to rapid symptom resolution, sparing patients from unnecessary systemic immunosuppression and the discontinuation of antineoplastic immunotherapy.

NCMP-05. CLINICAL AND RADIOGRAPHIC IMPROVEMENT WITH REPLACEMENT OF FOLATE METABOLITES IN A PATIENT WITH INTRATHECAL METHOTREXATE-INDUCED MYELOPATHY

Abstract Methotrexate (MTX)-induced myelopathy is a rare but serious adverse effect of intrathecal (IT) MTX, which may mimic subacute combined degeneration (SCD). MTX disrupts the normal synthesis of methionine, which plays an important role in maintaining myelin sheath integrity, resulting in degeneration of the dorsal columns. This degeneration does not respond to classic treatment with vitamin B12 and folate supplementation, unlike SCD. Here, we describe a case of a 45-year-old woman with Philadelphia-positive B-cell acute lymphoblastic leukemia treated with hyperCVAD regimen with ponatinib, who after 14 doses of prophylactic IT MTX, developed progressive lower extremity weakness, paresthesias, gait instability, saddle anesthesia, and bowel/bladder dysfunction. Her neurologic exam was also notable for diffuse hyporeflexia. The onset of symptoms followed a diarrheal infection, and an initial MRI spine showed no evidence of abnormal enhancement. She was initially treated with intravenous immunoglobulins for presumed acute inflammatory demyelinating polyneuropathy. She then re-presented one week later with progressively worsening symptoms. A repeat MRI spine revealed a new longitudinally extensive T2 hyperintense signal within the dorsal columns from T7 to T12. CSF results were notable for mild pleocytosis and increased myelin basic protein; the latter of which is often seen in MTX-induced myelopathy. The patient received high-dose administration of key metabolites of the methyl-transfer pathway including S-adenosylmethionine (PO 400mg three times daily), folinate (IV 20mg four times daily), cyanocobalamin (PO 1000mcg once daily) and methionine (PO 5mg once daily) for 7 days. This treatment regimen resulted in both clinical and radiographic improvement. Subsequent MRI spine demonstrated complete resolution of the abnormal signal in the thoracic cord. This case highlights (1) the diagnostic complexity of IT MTX-induced myelopathy (2) the role response to treatment plays in uncovering this diagnosis, and (3) how the replacement of folate metabolites facilitates both radiographic and clinical improvement in IT MTX-induced myelopathy.

NCOG-40. RARE ADVERSE EFFECT OF TEMOZOLOMIDE IN A 65-YEAR-OLD FEMALE WITH GLIOBLASTOMA MULTIFORME: A CASE REPORT

Abstract BACKGROUND Temozolomide, an antineoplastic agent is primarily used to treat certain brain tumors, including glioblastoma multiforme (GBM). Common side effects include nausea, vomiting, constipation, loss of appetite, alopecia (hair loss), headache, fatigue, convulsions and rash. A rare (less than 1%) adverse effect includes aplastic anemia refractory to treatment. Herein we present a case of Temozolomide induced severe bone marrow suppression in a 65-year-old woman with GBM refractory to any treatment CASE PRESENTATION A 65-year-old female presented with dizziness and left-hand numbness. Imaging revealed a right hemisphere mass and she underwent partial resection with pathology showing GBM, IDH wildtype, with CDKN2A/B deletion. She was started on radiation therapy with concurrent temozolomide. After nearly 5 weeks of temozolomide/RT, she developed severe thrombocytopenia/neutropenia with onset of neutropenic fever and severe CMV infection, leading to her demise within a week. DISCUSSION Life threatening refractory cytopenias is a very rare side effect of Temozolomide with a high rate of morbidity/mortality. In the case of our patient, she initially had weekly CBC’s which were stable and hence was switched to a monthly schedule. The patient’s ANC and platelets showed a precipitous drop within a month and ended up with aplastic anemia. The development of this rare complication underscores the importance of increased awareness about this often-fatal adverse event and possibly more frequent monitoring to recognize it early, especially in these patients with an already limited life expectancy. A more tailored approach to monitoring blood work may be needed depending on patient factors. CONCLUSIONS Aplastic anemia refractory to treatment is a rare and life threating adverse effect of temozolomide. The frequency of checking blood work for patients on Temodar has not been definitively established with protocols ranging from once weekly to monthly. Given the potential for this fatal adverse event, it is important to develop better tools to help identify patients in whom more frequent monitoring may be necessary.

Sacituzumab-govitecan-induced severe acute tubulointerstitial nephritis requiring hemodialysis

BackgroundSacituzumab govitecan is an antibody-drug conjugate that is FDA approved for refractory metastatic triple-negative breast cancer. It targets the human trophoblastic cell-surface antigen 2 (Trop-2) with SN-38, a topoisomerase I inhibitor, attached to the antibody [1]. SN-38 breaks DNA strands and induces tumor apoptosis [2]. Acute kidney injury (AKI) is one of its adverse effects mainly prerenal due to gastrointestinal toxicity, but it has not been reported to cause acute tubulointerstitial nephritis (ATIN).Case PresentationThis report describes a rare adverse effect of sacituzumab govitecan, the approach to diagnosing the etiology of the patient’s AKI, and the mechanism by which sacituzumab govitecan causes ATIN. A woman with metastatic ER positive, PR positive, HER2 negative breast cancer who was initiated on sacituzumab govitecan presents with vomiting and diarrhea, and findings of nephrotic-range proteinuria, negative anti-PLA2R antibody, and severe AKI requiring hemodialysis. She underwent kidney biopsy and pathology showed ATIN characterized by patchy interstitial inflammation alongside tubular injury without glomerular and vascular involvement. With intermittent renal replacement therapy, furosemide challenge, and a course of prednisone, the patient’s kidney function recovered.ConclusionsSacituzumab has a high affinity for Trop-2 protein which is also expressed within the collecting ducts, and to a lesser extent, the proximal tubule. Individuals, such as this patient, who express a homozygous genotype for UGT1A1*28 allele are at increased risk for AKI from sacituzumab govitecan due to decreased glucuronidation of SN-38.

Investigating Osteomyelitis as a Rare Adverse Effect of Vaccination in the Pediatric Population.

Immunization is a preventive measure of crucial importance. As with any other medication, side effects are a possibility and include the rare occurrence of severe infections, such as osteomyelitis. We report an unusual case of pediatric osteomyelitis following vaccination and provide a review of similar reports submitted to the Vaccine Adverse Event Report System (VAERS), aiming to explore the association between the vaccination procedure and the occurrence of osteomyelitis in childhood. A previously healthy infant, with no history of trauma or infection, presented with hyperpyrexia, swelling, and functional impairment in the left leg and was eventually diagnosed with osteomyelitis of the left femur. An edema was noted at the site of the injection that he received days before for immunization purposes. The infection required surgical drainage and a four-week-long intravenous antibiotic treatment, and the patient was discharged upon showing improved clinical conditions. Forty-seven reports of similar cases submitted to VAERS between 1994 and 2023 were collected, and several cases from the literature, including a case of femoral osteomyelitis in a newborn vaccinated against Hepatitis B, attributed to improper injection technique. Another case was reported in a 15-year-old girl, which aligned with six similar cases of osteomyelitis in adolescents following HPV vaccines collected from VAERS. Despite the small sample number, the findings that in 77% of cases the infection was localized in the vaccinated limb and that symptoms appeared on average 4.3 days (IQR 1.0-5.7 days) post-vaccination suggest a possible link to the injection procedure and highlight the need to adhere to recommendations regarding skin preparation and the selection of the appropriate needle length and injection site.

Unexpected multiple sclerosis-like symptoms in a rheumatoid arthritis patient treated with Etanercept: A case report.

Although tumor necrosis factor (TNF) inhibitors are used to prevent autoimmune disease, but they can cause adverse effects. Multiple sclerosis syndrome is one of the rare complications following treatment with TNF inhibitor. We reported a case of rheumatoid arthritis with unfavorable outcome post Etanerecept therapy. Tumor necrosis factor (TNF) inhibitors are prescribed to treat various autoimmune diseases such as rheumatoid arthritis (RA). Etanercept, a human anti-TNF monoclonal antibody, is a therapeutic option in autoimmune and inflammatory diseases. One of the rare adverse effects of Etanercept is developing central nervous system and peripheral nervous system demyelination however, there is controversy in the cause of it. In this case, we presented a 35-year-old woman with multiple sclerosis (MS)-like symptoms due to taking Etanercept. She had a history of RA since the age of 18 years and was referred to the emergency department with signs and symptoms of para paresthesia, progressive paraparesis of both lower limbs, and urinary retention a year after Etanercept treatment. We discontinued the Etanercept and started Methylprednisolone and Rituximab. Rapid clinical improvement was noted and in the approximately 6-month follow-up, she did not exhibit any neurological worsening. So it is probable that the initiation of Etanercept triggered MS-like syndrome in these patients and healthcare practitioners should take heed of this adverse effect.

Clinical characteristics, treatment and outcome of subacute cutaneous lupus erythematosus induced by PD-1/PD-L1 inhibitors.

PD-1/PD-L1 inhibitors have increasingly been associated with the occurrence of subacute cutaneous lupus erythematosus (SCLE), but the clinical characteristics and outcomes remain under-explored. Literature on PD-1/PD-L1 inhibitors induced SCLE was retrieved from Chinese and English databases until June 31, 2024, and clinical data of patients were extracted for retrospective analysis. Twenty-nine patients participated, with a median age of 63 years (range 43, 80). The most frequently reported drugs were Nivolumab (51.7%) and pembrolizumab (31.0%). The median time from treatment initiation to SCLE onset was 3 months (range 0.5, 47). Cutaneous manifestations presented primarily as papulosquamous lesions (65.5%) and erythema annulare (31.0%), predominantly occurring on the trunk (51.7%) and arms (51.7%). Serological analysis revealed positive anti-Ro antibodies in 91.7% of patients, positive antinuclear antibodies in 75.0%, and positive anti-La antibodies in 50.0%. Skin biopsies showed interface dermatitis in 65.5% of cases and lymphocyte infiltration in 82.8%. Treatment with topical corticosteroids, systemic corticosteroids, and hydroxychloroquine led to gradual improvement or resolution of the rash, with a median recovery time of 1 month (range 0.5, 11). As the use of PD-1/PD-L1 inhibitors in oncology increases, SCLE should be recognized as a rare cutaneous adverse effect. Histological and serological evaluations play a critical role in diagnosing SCLE. Typically, SCLE resolves on its own with appropriate local and systemic treatment.

Successful Surgical Treatment of Coronavirus Disease 2019 (COVID-19) Vaccination Related Upper Extremity Lymphedema : Case Report

Lymphedema is rare adverse effect of COVID-19 vaccination which was reported at several literatures. We present a case of surgically treated secondary lymphedema after the COVID-19 vaccination. The patient presented lymphedema at the upper extremity with no specific history except the COVID-19 vaccination 18 months before the visit. LVA and liposuction for the posterolateral aspect of forearm and upper arm was performed. The volume of the affected arm was reduced to more than 54 percent at the postoperative 8 months. With precise surgical planning, secondary lymphedema occurred after the COVID-19 vaccination could be successfully treated surgically.

Treatment for osteoporosis and risk of osteonecrosis of the jaw among female patients in the United Kingdom Clinical Practice Research Datalink.

Osteonecrosis of the jaw (ONJ) is a rare adverse effect of antiresorptive drug use; however, the magnitude of risk in osteoporosis patients has not been clearly described. We conducted a cohort study among cancer-free female patients aged 40-89 with, or at risk for, osteoporosis in United Kingdom Clinical Practice Research Datalink (CPRD) Aurum. We followed patients from first osteoporosis treatment until first of osteonecrosis diagnosis, age 90, record end, or other prespecified censoring event, and accumulated person-time by osteoporosis treatment. ONJ cases were selected from CPRD Aurum and linked Hospital Episode Statistics data using an algorithm and manual review. We estimated incidence rates (IR) of ONJ by current treatment type and post discontinuation. We conducted a nested case-control analysis to further describe risk by cumulative dose and duration of antiresorptive therapies. Among 467,654 eligible patients, there were 208 ONJ cases. IR among patients currently treated with antiresorptives (primarily alendronate) was 1.2 (95% confidence interval [CI] 1.0-1.4) per 10,000 person-years. Compared with past use of antiresorptives, odds ratios of ONJ were 3.0 (95% CI 1.5-5.7) after 2-3 years of treatment and 8.1 (95% CI 4.4-15) after 10 years. However, absolute risks remained low (~ 0.05% after 5 years and ~ 0.18% after 10 years) and elevated risks diminished to near zero within 6 to 9 months of discontinuation. Risk of ONJ increased after 2-3 years of treatment with antiresorptives; however, the absolute risk was low and returned to baseline shortly after treatment discontinuation.

Preferences of patients with multiple chronic diseases for medication in rural areas of an Eastern Province China: a discrete choice experiment.

Multiple Chronic Diseases (MCD) are the co-occurrence of two or more chronic conditions within an individual. Compared to patients with a single chronic disease, those with MCD face challenges related to polypharmacy, which increases the risk of adverse drug events, side effects, and drug-drug interactions. Understanding the specific medication preferences of patients with MCD is crucial to optimize treatment plans and enhance treatment safety. This study aims to evaluate the medication preferences among patients with multiple chronic diseases in rural areas of an eastern province of China. A discrete choice experiment (DCE) was used to measure patients' medication preferences. According to literature research, expert panel discussions, and in-depth patient interviews, we identified six attributes: monthly out-of-pocket cost, onset speed of action, adverse effects, whether it is covered by health insurance, origin of medications, and types of medications. The conditional logit models (CLM) and mixed logit models (MIXL) were used to evaluate the choice data. Willingness to pay (WTP) was used to reflect the monetary value that patients were willing to pay or receive reimbursement after changes in different attribute levels. A total of 956 respondents were included in the analysis. Of which, 68.62% were female, with an average age of 68 years, and 65.89% had a Body Mass Index (BMI) greater than or equal to 24. Statistical significance was observed for all attributes (p < 0.001). The preferred medication for patients encompassed low monthly out-of-pocket costs, rapid onset of action, rare adverse effects, and a preference for Western medicine, health insurance-covered medication and domestic medication. The onset speed of action was a primary consideration for patients, who demonstrated a willingness to pay an additional CNY151.37 per month for a medication with a rapid onset of action. Rural patients with multiple chronic diseases preferred medications with rapid onset, rare adverse, Western medications, domestic medication, and health insurance-covered medication. Medical staff can effectively combine the Health Belief Model (HBM) to help patients with multiple chronic diseases improve their confidence and understanding of medication selection, to improve their health management.

6411 Ozempic - Oh no! Acute Renal Failure Associated with Initiation of Semaglutide

Abstract Disclosure: K. Barney: None. D. Tahir: None. A. Pannu: None. R. Saeed: None. Background: Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist which has been proven to reduce weight in those with obesity and improve glycemic control in patients with type II diabetes mellitus. The effect of semaglutide on kidney function has not been well established. The phase 3b SUSTAIN trials revealed that when compared with other GLP-1 agonists, semaglutide exhibited more frequent acute kidney injuries [1-3]. The SUSTAIN 6 trial reported two instances of acute renal failure (ARF) in patients with chronic kidney disease, and one case of ARF in a patient with normal kidney function who was treated with semaglutide [3]. Despite these reports, the SUSTAIN 1-9 trials report no significant decline in kidney function associated with semaglutide [3-6]. Case: We present the case of a 58-year-old male with a past medical history of human immunodeficiency virus (HIV), type II diabetes mellitus, and hypertension who presented to the hospital with ARF after initiation of Ozempic (semaglutide) two months prior to presentation. On admission, vitals were stable and physical examination was benign. His pertinent labs were blood urea nitrogen (BUN) 55 mg/dL, creatinine 5.94 mg/dL (baseline 1.2 mg/dL), and urinalysis with 2+ protein. To determine the cause of his renal failure, urine sodium and creatinine were obtained to calculate his fractional excretion of sodium, which was found to be consistent with intrinsic renal disease. Further workup, including renal ultrasound, urine protein, urine eosinophils, complement and free light chain levels, and creatinine kinase, were unrevealing for cause of intrinsic renal injury. He was managed with intravenous fluids and his creatinine improved to 2.03 mg/dL. Given the acute onset of the patient’s renal failure and recent initiation of Ozempic, it was determined that this medication was the cause of his renal failure, and it was discontinued on discharge. He has since followed up with nephrology and endocrinology. He remains off Ozempic and is doing well. Conclusions: Our case highlights a rare but significant adverse effect of semaglutide on renal function. As the use of semaglutide has increased due to its rising popularity for weight loss and glycemic control in type II diabetes mellitus, the potential for renal injury should be considered and discussed with patients. Furthermore, it is imperative that semaglutide associated renal injury be considered as a cause for ARF in patients taking this medication. This case demonstrates that instances of ARF associated with semaglutide treatment are a cause for concern and further exploration. Presentation: 6/1/2024

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.

S4910 Gastroenterologist's Recognition of Rare Adverse Drug Effect Prevents Further Harm in a Patient with Small Bowel Obstruction Due to Lisinopril: A Case Report and Literature Review

S4910 Gastroenterologist's Recognition of Rare Adverse Drug Effect Prevents Further Harm in a Patient with Small Bowel Obstruction Due to Lisinopril: A Case Report and Literature Review

Alopecia as an uncommon side effect of single postoperative instillation of gemcitabine in patients with non-muscle-invasive urothelial carcinoma of the bladder.

274 Background: Single-dose administration of intravesical gemcitabine is a common part of clinical practice following transurethral resection (TURBT) of non-muscle invasive bladder cancer (NMIBC). Although the side effect profile for gemcitabine is well characterized in systemic and local therapy, rare side effects continue to be identified with ongoing use. Here we identify several cases of treatment-related alopecia with adjuvant single dose intravesical administration for NMIBC after TURBT. Methods: Using our single-institutional IRB-approved Cysview registry database, we identified patients who underwent TURBT for NMIBC and received a single dose of intravesical gemcitabine post-TURBT between January 2020 and June 2023 at Keck Hospital of USC. Patients with a history of low grade NMIBC or those undergoing their first TURBT received 2g of gemcitabine dissolved in 100 cc of saline 1h after tumor resection. We reviewed patient-reported adverse events and included patients who reported alopecia following gemcitabine instillation. Patients were questioned on the degree and length of hair loss and information was collected from patient charts. Results: Overall, 9 patients (2 male, 7 female) reported hair loss following single dose intravesical gemcitabine after the TURBT. One patient had an autoimmune disease. The hair loss started within a few days of gemcitabine instillation and resolved spontaneously. The table shows the clinicopathologic characteristics of this cohort in detail. Three patients experienced severe hair loss. The resection extent during TURBT was classified as small (&lt;2 cm), medium (2-5 cm), or large (&gt;5 cm). Three patients had a large resection, 2 patients a medium one and 3 patients a small resection. None of the patients had previous intravesical gemcitabine; however, 2 patients had a history of intravesical BCG and 1 had intravesical mitomycin before. Conclusions: This study demonstrates that hair loss is a rare but possible adverse effect of intravesical gemcitabine after TURBT. Prior to surgery, patients should be counseled regarding this potential side-effect. Additional research and multicenter studies are required to describe the occurrence and cause of this adverse event. Demographic, clinical, and pathologic characteristics of patients. Patient ID Age Sex History of other IVT Pathology of TURBT Number of prior TURBT Resection extent Severity of hair loss Prior UBC 1 73 M None LGTa 1 large moderate LGTa 2 88 M MMC LGTa multiple large severe LGTa 3 76 F BCG CIS multiple small moderate HGT1 in upper tract,HGTa &amp; LGTa in bladder 4 56 F BCG HGTa multiple large severe LG+HGTa 5 66 F None HGTa none small moderate None 6 84 F None LGTa none small severe None 7 62 F None LGTa 1 medium moderate LGTa 8 68 F None HGTa multiple medium mild LGTa 9 64 F None LGTa none medium severe None LG= Low Grade, HG = High Grade.

Optic Atrophy Occurring with Anti‐Tumor Necrosis Factor Alpha Therapy: A Case Report

Ocular involvement related to treatment with tumor necrosis factor alpha inhibitors is a rare adverse effect that may lead to irreversible outcomes. We illustrate through this report a case of optic atrophy under Etanercept in a patient with spondyloarthritis. The diagnosis was suspected due to visual acuity impairment, and was confirmed by ophthalmological examination. Although the TNF-blockers were discontinued and corticosteroids were administered, the follow-up examination did not reveal any improvement in visual acuity. This is a potential serious complication of TNF inhibitors that rheumatologists should recognize when monitoring patients with rheumatic diseases.

5-Fluorouracil-Induced Leukoencephalopathy: Report of Two Cases and Review of Literature

Abstract5-fluorouracil (5FU) forms an important component of chemotherapy regimens used in various gastrointestinal (GI) adenocarcinomas and head and neck squamous cell carcinomas. Leukoencephalopathy is a rare adverse effect of 5FU, mediated by hyperammonemia and hyperlactatemia. We report cases of two patients with GI adenocarcinomas who developed neurological symptoms while on 5FU infusion. The neuroimaging and biochemical parameters were suggestive of toxic leukoencephalopathy. They were managed with cessation of the drug and short-term antiepileptic therapy. We also discuss the pathophysiology of this adverse effect and its management.

Delirium Incidence and Predictors in SARS-CoV-2 Vaccinated Residents in Long-Term Care Facilities (LTCF): Insights from the GeroCovid Vax Study

ObjectiveSARS-CoV-2 vaccination can bring an important benefit for older people in terms of reduction of mortality and hospitalization; however, reports of rare adverse effects like altered consciousness and delirium among this demographic have raised concerns. This study aimed to assess delirium incidence post-SARS-CoV-2 vaccination and its predictors in older residents across 60 Italian long-term care facilities (LTCFs). DesignThis is a prospective cohort study considering data from GeroCovid Vax, a multicenter cohort study jointly performed by the Italian Society of Gerontology and Geriatrics (SIGG) (Florence, Italy) and the Italian National Institute of Health (Istituto Superiore di Sanità—ISS, Rome, Italy), and sponsored by the Italian Medicines Agency (Agenzia Italiana del Farmaco—AIFA). Setting and ParticipantsGeroCovid Vax enrolled LTCFs residents aged ≥60 who received at least 1 anti–SARS-CoV-2 vaccine dose. MethodsBaseline data covered sociodemographic details, chronic diseases, medications, nutritional status, cognitive and functional assessments, mobility, and frailty. Delirium was assessed post-first, second, and booster vaccine doses using DSM-5 criteria. Data analysis involved descriptive statistics, multivariate logistic regression, and network analysis. ResultsA total of 2521 participants (mean age 83.10 ± 9.21 years, 70.7% female) were analyzed. Delirium incidence post-first, second, and booster doses was 3.5%, 1.6%, and 1.5%, respectively. Age, preexisting cognitive disorders, and frailty were significant predictors of delirium, with odds ratios (ORs) of 1.70 (95% CI, 1.08–2.77), 2.05 (95% CI, 1.40–2.97), and 1.77 (95% CI, 1.25–2.52), respectively. Prior use of antipsychotics (OR, 1.75; 95% CI, 1.22–2.51) and antidepressants (OR, 1.77; 95% CI, 1.25–2.52) correlated significantly with delirium. Network analysis indicated a strong association between anorexia and delirium. Conclusion and ImplicationsPost-vaccination delirium is infrequent and decreases with subsequent doses. Timely assessments for frailty and cognitive impairment could aid in stratifying delirium risk among LTCF residents, facilitating enhanced prevention measures and close monitoring for delirium indicators.

The annoyance of singultus: a case report of a rare adverse effect after epidural steroid injection

ObjectiveCervical epidural steroid injections (ESIs) can provide effective pain management for patients suffering from chronic neck pain due to various pathological changes of the cervical spine. There are several rare adverse effects reported from interventional pain procedures, including persistent hiccups (“singultus”). Based on a limited number of cases, we propose a modified treatment algorithm for this adverse outcome (Fig. 3).Case reportSingultus has been documented as an adverse effect of interventional pain procedures, including epidural steroid, facet joint, and sacroiliac joint injections. We describe the case of a general contractor who presented to our clinic with chronic neck pain and central canal stenosis. The patient received an uncomplicated lumbar ESI in the past and was recommended for a cervical interlaminar ESI. After an uneventful C6-C7 interlaminar ESI with dexamethasone, 1% lidocaine, and normal saline the patient developed singultus. Baclofen was sent to his pharmacy, but this was unsuccessful at alleviating his hiccups. The patient was subsequently started on chlorpromazine and found relief from his symptomatology.ConclusionPersistent hiccups after ESI or interventional pain procedures can be treated with conservative measures and non-pharmacologic methods, with escalation to therapy with baclofen, gabapentin, pregabalin, metoclopramide, chlorpromazine, other antipsychotic or antidopaminergic agents, and possible dual or triple therapy if further indicated.