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The advent of anaplastic lymphoma kinase (ALK) inhibitors has revolutionized the treatment of ALK-rearranged malignancies, establishing these agents as vital components of precision oncology. Despite their proven efficacy in prolonging progression-free and overall survival, ALK inhibitors are associated with notable adverse events, particularly cardiopulmonary complications such as pleural and pericardial effusions. This study investigates the real-world prevalence and risk of these effusions associated with five ALK inhibitors, crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib, through disproportionality analysis using the FAERS pharmacovigilance database. The data revealed elevated reporting odds ratios (RORs) for pleural and pericardial effusions, with notable variability among the agents. Crizotinib exhibited RORs of 7.76 (95% CI: 6.60-9.12) and 9.00 (95% CI: 7.10-11.41) for pleural and pericardial effusions, respectively. Ceritinib demonstrated RORs of 7.36 (95% CI: 5.16-10.50) and 10.80 (95% CI: 6.79-17.19), respectively. Alectinib showed lower RORs of 4.76 (95% CI: 3.80-5.97) and 6.67 (95% CI: 4.92-9.04). Brigatinib displayed elevated RORs of 8.70 (95% CI: 6.58-11.52) and 7.87 (95% CI: 4.95-12.51). Lorlatinib presented the highest risk, with RORs of 8.61 (95% CI: 6.72-11.02) and 12.57 (95% CI: 9.08-17.38). This study highlights the critical need for vigilant pharmacovigilance and a multidisciplinary approach to balance the oncologic benefits of ALK inhibitors against their cardiopulmonary risks. By enhancing awareness and fostering proactive management, these findings aim to support the safe and effective use of ALK inhibitors in treating ALK-rearranged malignancies.

Background Low‐dose oral minoxidil (LDOM) is used to treat hair loss, but the literature on its safety profile is relatively sparse. Aims Using the FDA Adverse Event Reporting System (FAERS) database, we determined signals for adverse events (AEs) with LDOM use. Methods Four sets of case/noncase study disproportionality analyses were conducted to determine reporting odds ratio (ROR) for 10 AEs including pericardial effusion (PE). The oral minoxidil dose ranges were: (i) ≤1.25 mg (i.e., 0–1.25 mg), (ii) ≤2.5 mg (i.e., 0–2.5 mg), (iii) ≤5 mg (i.e., 0–5 mg), and (iv) ≤10 mg (i.e., 0–10 mg). Results For ≤1.25 mg, we detected a signal for PE (ROR = 16.41, 95% CI: 2.29, 117.37, p < 0.05). For ≤2.5 mg, the analyses detected a signal for PE (ROR = 13.30, 95% CI: 5.96, 29.68, p < 0.05); the ROR in the absence of cardiac impairment was 5.34 (95% CI: 1.33, 21.37, p < 0.05); in the presence of cardiac impairment, the ROR was 49.42 (95% CI: 18.27, 133.66, p < 0.05). A signal for PE was also detected at ≤5 and ≤10 mg. For PE, there was a significant (p < 0.05) association with a patient outcome of “life threatening” only at the ≤10 mg dose range. Conclusions Our study, the first FAERS‐based signal detection study for LDOM, found significant associations between LDOM use and several AEs. In the absence of causal evidence, these correlations warrant more attention regarding safe use of LDOM. Until more safety data are available, we recommend using LDOM at the lowest effective dose (≤5 mg/day).

BackgroundNivolumab, a programmed death-1 (PD-1) inhibitor, is an immune checkpoint inhibitor particularly used in the treatment of malignant melanoma, non-small cell lung cancer and renal cell carcinoma. Immune-related adverse events are frequent under immunotherapies. Cardiotoxic side effects, initially thought to be rare, are more often encountered paralleling the expanding use of immune checkpoint blockade. Among them, pericardial effusion and tamponade deserve attention as they may present with unusual symptomatology.Case presentationWe report three cases of pericardial effusion under nivolumab for lung adenocarcinoma. Two cases of early and late-onset pericardial effusion were symptomatic with tamponade and one case occurred without any symptoms. Pericardiocentesis with pericardial biopsy was performed in symptomatic pericardial effusion followed by the administration of a corticotherapy. Pericardial biopsies showed infiltration of T-lymphocytes, mostly CD4+. Nivolumab was stopped in two cases and resumed for one patient. Pericardial effusion evolved positively in all cases with or without treatment.ConclusionsWe review the literature on pericardial effusion under nivolumab to further discuss the hallmarks of pericardial effusion under nivolumab and the management of nivolumab therapy in this situation. In conclusion, pericardial effusion as an immune-related adverse event under nivolumab appears less rare than initially thought and may require particular attention.

Minoxidil is an antihypertensive that works by directly dilating peripheral vessels. This medication is typically reserved for patients with resistant hypertension, whose blood pressure remains above goal despite being on multiple agents. A rare but potentially dangerous side effect of Minoxidil is drug-induced pericardial effusion. Here we report a case of a patient who was taking Minoxidil and subsequently developed a large pericardial effusion, with concerns for impending cardiac tamponade. •Pericardial effusion and tamponade are rare side effects with minoxidil use and can potentially be fatal if not recognized.•Minoxidil induced pericardial effusion is a diagnosis of exclusion and workup should be done to rule out other etiologies.•Treatment of pericardial effusion includes either pericardiocentesis if hemodynamically unstable or pericardial window.

Objective By using the FAERS database, we aim to identify and assess risk signals of adverse drug events (ADEs) potentially causing pericardial effusion, to inform clinical drug management and promote rational drug use. Methods We obtained reports of pericardial effusion events from the FAERS database spanning from the first quarter of 2004 to the second quarter of 2024, and identified the top 50 drugs ranked by report frequency or signal strength. Four algorithms, namely the reported odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS), were employed for signal detection of these drugs. Furthermore, for drugs with positive signals, we conducted sensitivity analyses and employed the Weibull shape parameter test to perform a time to onset (TTO) analysis. Results We identified 20,057 ADEs related to pericardial effusion, involving 19,693 patients for analysis. The patient population comprised 10,187 males (51.7%) and 7,939 females (40.3%). Adults aged 18–65 years were the largest group (7,798 cases, 39.6%). Regarding clinical outcomes, 9,924 patients (50.4%) experienced hospitalization, and 2,770 cases (14.1%) resulted in death. Ranked by the ROR risk signal strength, the top 3 drugs were hydralazine [ROR (95% CI): 27.11 (22.28–33)], dasatinib [ROR (95% CI): 15.62 (14.07–17.33)], and mesalazine [ROR (95% CI): 8.99 (6.84–11.8)]. We conducted a TTO analysis for the 26 drugs with positive signals. The median TTO and interquartile range (IQR) for the top 3 drugs causing the earliest pericardial effusion were: cytarabine 14 (7.5,38), selexipag 14.5 (4.25, 157.75), dabigatran etexilate 29 (9, 229). Most drugs exhibited an early failure type. Conclusion This study systematically compiled a list of drugs with potential risks of causing pericardial effusion. There is a significant association between pericardial effusion and the use of hydralazine, dasatinib, and mesalazine. Moreover, pericardial effusion is more common in patient groups receiving treatments with antineoplastic and immunomodulating agents.

Background While oral minoxidil (OM) has been associated with pericardial effusion (PE), its etiology is presently inconclusive. Aims We characterized patient‐ and drug‐related factors across reports from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) for PE and OM. Methods Our observation period spanned 18.5 years. Parametric and non‐parametric analyses were used; we stratified our findings according to two groups of adverse events (AEs), namely, PE and all other AEs. Results Across reports of OM (n = 2747), positive dechallenge (complete resolution or subsiding of AE upon discontinuation of OM) was significantly more likely to occur for PE than for all other AEs (p < 0.05). Furthermore, OM was significantly more likely to play a primary role in PE compared to all other AEs (p < 0.05). The proportion of men was significantly higher in OM reports of PE than in OM reports of all other AEs (p < 0.05). We also identified six reports of PE and topical minoxidil. Conclusions Though findings from spontaneously reported data never prove causality, our findings on dechallenge and purported role may suggest one. There were no reports of PE at a dose < 2.5 mg/day, 2/35 reports at 2.5 mg/day, and 8/35 reports at 5 mg/day. Overall, the results of statistical analyses support that the relationship between OM and PE is dose independent. Caution should also be taken when applying minoxidil topically because of reports of PE associated with this route of administration.

Introduction: Insulin induced edema (IIE) is a rare condition, usually found in newly diagnosed diabetes patients, either after insulin treatment initiation or after dose increment. It is a self-limited process, rarely associated with serosal effusions. Teenage girls with type 1 diabetes (T1DM) are most commonly affected.Patient and Methods: A 12-year-old girl was diagnosed with ketoacidosis (DKA). Seven days after initiation of the insulin treatment, at a stable total daily dose of insulin (TDDI) of 0.55 IU/kg, she came with two kilograms weight gain in only two days and edema of the feet and calves. Ultrasound of the heart found a 7 mm pericardial effusion. The diagnostic workout included clinical examination, biochemical, hormonal, allergen analyses and imaging which excluded other known causes of swelling. Conclusions: We describe an adolescent girl with newly diagnosed T1DM and a rare association of peripheral insulin-induced edema and pericardial effusion. Short-term diuretic treatment and salt restriction resolved this rare complication of insulin treatment.

Background Nivolumab has been used for the treatment of various types of cancers and has achieved improvements in overall survival. However, nivolumab can cause a variety of adverse events (AEs). Among these, cardiac-specific AEs have received little attention in clinical trials, despite their life-threatening potential. Objective The present study aimed to determine the risk of nivolumab-induced cardiac AEs, time to onset, incidence rates, and post hoc outcomes using the Japanese Adverse Drug Event Report database. Methods We analyzed data for the period between April 2004 and March 2021. Data on cardiac AEs were extracted and relative risk of AEs was estimated using the reporting odds ratio (ROR). Results We analyzed 1,772,494 reports and identified 18,721 reports of AEs caused by nivolumab. Of these, 409 reports involved cardiac AEs. Signals were detected for four cardiac AEs: myocarditis; pericardial effusion; pericarditis; and immune-mediated myocarditis. Among these, myocarditis was the most frequently reported (35.0%) and included fatal cases. A histogram of times to onset showed nivolumab-associated AEs occurring 41–127 days after starting administration, with outlier cases of myocarditis or pericardial effusion occurring after more than one year, both with catastrophic consequences. Conclusion This study focused on cardiac AEs caused by nivolumab as post-marketing AEs. Myocarditis and pericardial effusion have been associated with some fatal cases after administration of nivolumab. Patients should be monitored for signs of onset for these AEs, not only at the start of administration, but also over an extended period after nivolumab administration.

Advanced thymic carcinomas have limited treatment options. Recently, lenvatinib was approved for advanced thymic carcinoma treatment. However, the clinical benefit of lenvatinib re‐administration in patients with advanced thymic carcinoma who developed prior lenvatinib treatment resistance (lenvatinib rechallenge) remains unclear. Here, we present a case treated with lenvatinib rechallenge for advanced thymic carcinoma who was previously treated with lenvatinib as the second‐line treatment followed by multiple cytotoxic agents. Disease control rapidly deteriorated after the eighth line of treatment because of uncontrollable right pleural and pericardial effusion, which required repeated thoracic and pericardial drainage. Shortly after lenvatinib re‐administration, rapid pleural and pericardial effusion reduction was observed. Thereafter, the patient achieved sustained clinical response with good pleural and pericardial effusion control for approximately 7 months. Our case might suggest lenvatinib rechallenge as a treatment option for patients with advanced thymic carcinoma, especially those with poor pleural and pericardial effusion control. We present a case treated with “lenvatinib rechallenge” for advanced thymic carcinoma who was previously treated with lenvatinib followed by multiple cytotoxic agents. Shortly after lenvatinib rechallenge, rapid pleural and pericardial effusion reduction was observed. Our case might suggest lenvatinib rechallenge as a treatment option for patients with advanced thymic carcinoma.

•Patients on Tyrosine Kinase Inhibtors (TKI) may develop pleural and pericardial effusions•Imaging to assess for pleural and pericardial effusions closer to date of surgery may be helpful•Pleural and pericardial effusions are most likely to present in the first 4months of TKI initiation