Expert Opinion On Drug Safety[JOURNAL]
Sun
200 papers
Could anticholinergics accelerate ALS progression? A critical perspective on drug safety and disease vulnerability.
Price TR, Chang CY, Skinner K … +6 more , Dinneny M, Nafezi P, Kuramoto L, De Vera MA, Cashman NR, Cragg JJ
Expert Opin Drug Saf · 2026 Jun · PMID 42377311 · Publisher ↗
INTRODUCTION: Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder with limited treatment options and diverse symptoms necessitating active management. Anticholinergic medications are frequentl...
INTRODUCTION: Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder with limited treatment options and diverse symptoms necessitating active management. Anticholinergic medications are frequently used in ALS care, particularly for sialorrhea and mood disturbances. Their cumulative effects, termed anticholinergic burden, may pose underrecognized risks in this neurologically vulnerable population. This review highlights a plausible safety signal and outlines priorities for future research. AREAS COVERED: This narrative review synthesizes evidence from non-ALS populations reporting associations between higher anticholinergic burden and cognitive decline, respiratory complications, functional deterioration, and mortality. Evidence was identified through targeted PubMed/MEDLINE and Embase searches with reference chaining, emphasizing recent and seminal studies. Mechanistic overlap with ALS pathophysiology, including neuromuscular junction disruption, impaired cholinergic signaling, and neuroinflammation, supports biological plausibility for harm. Current ALS guidelines do not address cumulative anticholinergic exposure, leaving clinicians without a framework for evaluating risk or deprescribing. EXPERT OPINION: This article proposes a testable hypothesis that anticholinergic burden may represent a clinically relevant yet unmeasured risk factor in ALS. Emerging pharmacoepidemiologic methods and validated burden tools offer approaches to quantify exposure and evaluate relationships with ALS outcomes, supporting safer symptomatic management. Prioritizing longitudinal studies and integrating burden assessment into multidisciplinary care may help clarify risk.
Safety profile of teprotumumab-trbw, the first and only FDA-approved treatment for thyroid-associated ophthalmopathy.
Smith TJ
Expert Opin Drug Saf · 2026 Jun · PMID 42295149 · Publisher ↗
INTRODUCTION: Teprotumumab (Tepezza), a monoclonal antibody targeting the insulin-like growth factor 1 receptor (IGF-IR), was approved in January 2020 by the US Food and Drug Administration for treatment of thyroid-assoc...
INTRODUCTION: Teprotumumab (Tepezza), a monoclonal antibody targeting the insulin-like growth factor 1 receptor (IGF-IR), was approved in January 2020 by the US Food and Drug Administration for treatment of thyroid-associated ophthalmopathy (TAO). The drug was found to be effective and generally well-tolerated in two registered clinical trials and subsequent post-marketing trials. AREAS COVERED: A search of PubMed and other databases of medical and scientific literature was conducted. Key search terms included 'teprotumumab,' 'Tepezza,' 'thyroid-associated ophthalmopathy treatment,' and 'Graves' disease treatment.' Two adverse events (AEs), auditory abnormalities and hyperglycemia, were the focus of this review. As of 7 December 2025, 392 citations were identified in PubMed using teprotumumab as the search term. Of these, 29 publications primarily reported AEs or safety concerns associated with teprotumumab. The two most consequential AEs, hearing dysfunction and hyperglycemia, were identified in phase 2 and phase 3 clinical trials. EXPERT OPINION: Teprotumumab, the only FDA-approved therapy for TAO, is generally effective. It has been associated with several side effects; the most concerning are hearing dysfunction and hyperglycemia. Due diligence in pretreatment, intra-treatment and post-treatment monitoring is essential. Detailed benefit-risk analysis should be shared with all patients for whom use of the drug is being considered.
A systematic review and meta-analysis of safety and efficacy parameters of sotatercept in the therapy of pulmonary arterial hypertension.
Dutta S, Shah R, Singhal S … +4 more , Singh M, Dholariya S, Chawla S, Katoch C
Expert Opin Drug Saf · 2026 Jun · PMID 42246435 · Publisher ↗
INTRODUCTION: Pulmonary arterial hypertension (PAH) has responded favorably to the new fusion protein named sotatercept. This study aimed to evaluate the safety and efficacy of sotatercept in PAH. METHODS: The online dat...
INTRODUCTION: Pulmonary arterial hypertension (PAH) has responded favorably to the new fusion protein named sotatercept. This study aimed to evaluate the safety and efficacy of sotatercept in PAH. METHODS: The online databases like PubMed/Medline, Cochrane Library, and ClinicalTrials.gov were searched until 15 September 2024 for studies comparing sotatercept to placebo using keywords such as "sotatercept, pulmonary arterial hypertension, and 'fusion protein.' RESULTS: Of the 213 titles searched, after removing duplicates, 142 studies were evaluated for eligibility. Two RCTs were finally included. Subgroup analysis was conducted for the two doses (0.7 mg/kg and 0.3 mg/kg). In the safety analysis, there were no significant differences in total adverse events [RR = 1.03 (0.95, 1.12), I = 0, = 0.50], serious adverse events [RR = 0.96 (0.38, 2.42), I = 56, = 0.93], and mortality [RR = 0.39 (0.01, 11.81), I = 61%, = 0.59]. However, a significant difference was observed with non-serious adverse events [RR = 1.15 (1.03-1.30), I = 0%, = 0.02], telangiectasia [RR = 3.34 (1.26-8.83), = 0.02], thrombocytopenia [RR = 3.69 (1.23-11.0), I = 0%, = 0.02] and epistaxis [RR = 5.58 (2.20-14.13), = 0.0003]. No significant difference was observed with headache, nasopharyngitis, hypotension, neutropenia, nausea, diarrhea, rash, anemia, and dizziness. A significant change was observed with the majority of efficacy parameters, like Pro BNP [MD = -1150.38 (-1846.44, -454.32), I = 79, = 0.001], pulmonary vascular resistance [MD = -234.40 (-325.30, -143.51), I = 72, < 0.00001], pulmonary arterial wedge pressure ( = 0.007) and improvement in WHO functional class [OR = 3.23 (1.25, 8.34), I = 61, = 0.02]. CONCLUSION: This study demonstrates that sotatercept is more effective than placebo in treating PAH and has a fair safety profile. CLINICALTRIAL.GOV: Identifier numbers: NCT04576988 and NCT03496207 PROSPERO: CRD42024534695.
Tirzepatide data: safety first is safety always!
Janić M, Rabbani SA, El-Tanani M … +4 more , Rangraze I, Janež A, Maggio V, Rizzo M
Expert Opin Drug Saf · 2026 Jun · PMID 42201797 · Publisher ↗
INTRODUCTION: Tirzepatide, a dual GIP and GLP-1 receptor agonist, offers unprecedented efficacy for type 2 diabetes and obesity. Due to its rapid global adoption, understanding its complete safety spectrum is urgently ne...
INTRODUCTION: Tirzepatide, a dual GIP and GLP-1 receptor agonist, offers unprecedented efficacy for type 2 diabetes and obesity. Due to its rapid global adoption, understanding its complete safety spectrum is urgently needed to guide responsible prescribing and mitigate public health risks. AREAS COVERED: A literature search was conducted using PubMed and other public databases available to evaluate current evidence on the efficacy, safety, and metabolic impact of tirzepatide. The research discussed encompasses clinical trials and real-world data detailing the glycemic and weight reduction benefits of the drug. We examine its overall tolerability, covering common gastrointestinal events, including its high comparative risk for severe gastrointestinal events and treatment discontinuation, rare risks such as gallbladder and thyroid disorders, and the complex impact of the drug on skeletal muscle mass. EXPERT OPINION: While tirzepatide represents a paradigm shift in metabolic therapy, clinical management must evolve toward precision phenotyping to individualize patient risk-benefit trajectories. Future research must prioritize long-term functional outcomes to ensure that disease-modifying benefits are not offset by treatment-induced sarcopenia.
An update on the safety of biologics for the treatment of psoriasis.
McGuirt V, Patel H, Davis M … +1 more , Feldman S
Expert Opin Drug Saf · 2026 May · PMID 42149685 · Publisher ↗
INTRODUCTION: Biologic therapies have changed the management of moderate-to-severe psoriasis by targeting key immunologic pathways. With increasing real-world use, long-term safety profiles are important for clinical dec...
INTRODUCTION: Biologic therapies have changed the management of moderate-to-severe psoriasis by targeting key immunologic pathways. With increasing real-world use, long-term safety profiles are important for clinical decision-making. AREAS COVERED: The objective of this research is to provide an update on the safety of biologics over the past five years in psoriasis, including infection risk, malignancy, immunogenicity, and long-term outcomes. An informal literature review through PubMed was done using key search terms from 2020 to 2025. EXPERT OPINION: Biologic therapies are safe compared to older systemic drugs. Despite the minor risk for more common colds, which may be due to greater social interactions, the benefits far outweigh the risks. Biologics have facilitated improving psoriasis care, providing greater clearance with less risk of severe side effects.
Recent advances in trastuzumab and its antibody-drug conjugates-related liver injury.
Chen L, Li GH, Li CY
Expert Opin Drug Saf · 2026 May · PMID 42118005 · Publisher ↗
INTRODUCTION: Trastuzumab and its antibody-drug conjugates (ADCs) are pivotal in treating human epidermal growth factor receptor 2(HER2)-positive cancers. With the growing scope of clinical use, an increasing body of evi...
INTRODUCTION: Trastuzumab and its antibody-drug conjugates (ADCs) are pivotal in treating human epidermal growth factor receptor 2(HER2)-positive cancers. With the growing scope of clinical use, an increasing body of evidence from studies and case reports suggests that these agents can induce hepatotoxicity of varying severity. AREAS COVERED: This review synthesizes evidence from published clinical trials, preclinical studies, pharmacovigilance data, drug labeling information, meta-analyses and clinical guidelines to comprehensively evaluate the potential mechanisms, risk factors, potential predictive methods, and preventive strategies associated with liver injury induced by trastuzumab and its ADCs. EXPERT OPINION: Trastuzumab-related liver injury is uncommon but occurs more frequently with its antibody-drug conjugates, particularly trastuzumab emtansine (T-DM1), which can cause hepatopulmonary syndrome (HPS), nodular regenerative hyperplasia (NRH), and sinusoidal obstruction syndrome (SOS). Risk factors include dosage, treatment duration, and drug interactions. T-DM1 shows dose-dependent hepatotoxicity, while cytochrome P450 3A4 (CYP3A4) inhibitors may increase hepatic accumulation of trastuzumab deruxtecan (T-DXd). Trastuzumab mainly induces hepatocellular and cholestatic injury, whereas T-DM1 involves both HER2-dependent and independent pathways. Diagnosis relies on causality assessment, and most cases are reversible with liver function monitoring and timely dose adjustment.
Safety of anti-IL-5 compounds for the treatment of eosinophilic asthma with a focus on special populations.
Caminati M, Gagliani C, Bondi B … +5 more , Bagnasco D, Vijverberg SJH, Zurlo M, Maule M, Principe S
Expert Opin Drug Saf · 2026 May · PMID 42109084 · Publisher ↗
INTRODUCTION: Asthma treatment has undergone a substantial change since monoclonal antibodies have been approved as treatment. IL-5 is a crucial player within the immunological pathways underlying asthma pathobiology. Se...
INTRODUCTION: Asthma treatment has undergone a substantial change since monoclonal antibodies have been approved as treatment. IL-5 is a crucial player within the immunological pathways underlying asthma pathobiology. Selectively targeting IL-5 and its receptor demonstrated on long-term observations an optimal safety and efficacy profile in asthma patients. However, in some special populations, the evidence related to the safety data is still limited. AREAS COVERED: The present review summarizes the currently available literature on the overall safety of anti-IL-5 compounds, including a focus on partial vs complete blood eosinophil depletion in response to the different therapies. Furthermore, data on anti-IL-5 antibodies in children, pregnant patients and old people in terms of safety profile have been critically reviewed. EXPERT OPINION: Limited data are available in children, pregnant women and elderly. The last two categories are usually excluded by the clinical trials enrollment, and a few randomized studies are available for children. However, the real-world evidence, aligned with the highly selective mechanism of action, supports the implementation of the anti-IL-5 therapies in the three subgroups mentioned above. Of course, an individualized approach carefully evaluating the risk-benefit balance and a close monitoring are highly recommended in those patients.
Long-term cardiotoxicity outcomes of trastuzumab and cardiac safety of novel HER2-targeted therapies.
Esen SA, Uncu D, Sendur MAN
Expert Opin Drug Saf · 2026 May · PMID 42080343 · Publisher ↗
INTRODUCTION: Cardiotoxicity associated with HER2-targeted therapies represents an important clinical concern in the management of HER2-positive breast cancer, particularly as survival improves and patients are exposed t...
INTRODUCTION: Cardiotoxicity associated with HER2-targeted therapies represents an important clinical concern in the management of HER2-positive breast cancer, particularly as survival improves and patients are exposed to prolonged or sequential treatments. Trastuzumab has significantly enhanced outcomes but is associated with cardiac dysfunction, which may limit its use in patients with preexisting cardiovascular risk factors. With the expanding use of newer HER2-targeted agents, a clear understanding of their cardiac safety profiles is essential for optimizing long-term patient care. AREAS COVERED: This review evaluates the incidence, mechanisms, and clinical relevance of cardiotoxicity associated with trastuzumab and novel HER2-targeted therapies, including monoclonal antibodies, antibody - drug conjugates, and tyrosine kinase inhibitors. A literature search was conducted using PubMed and major oncology meeting proceedings, including the American Society of Clinical Oncology (ASCO) Annual Meeting and the San Antonio Breast Cancer Symposium. Randomized clinical trials, pooled analyses, long-term follow-up studies, and selected real-world observational studies reporting cardiac outcomes were reviewed. EXPERT OPINION: Available evidence suggests that trastuzumab-related cardiotoxicity remains clinically relevant, whereas newer HER2-targeted agents generally demonstrate favorable cardiac safety profiles with mostly asymptomatic and reversible events. These findings support individualized, risk-adapted cardiac monitoring strategies to balance oncologic efficacy with cardiovascular safety.
Safety of SGLT2 inhibitors for patients with type 2 diabetes: where are we now?
Scheen AJ
Expert Opin Drug Saf · 2026 Apr · PMID 42033800 · Publisher ↗
INTRODUCTION: Sodium-glucose cotransporter 2 inhibitors (SGLT2is) remain underused in clinical practice, one of the reasons may be the fear of adverse events which have been emphasized during the first years of use. This...
INTRODUCTION: Sodium-glucose cotransporter 2 inhibitors (SGLT2is) remain underused in clinical practice, one of the reasons may be the fear of adverse events which have been emphasized during the first years of use. This comprehensive review aims to give an update on the safety and tolerability profile of SGLT2is. AREAS COVERED: An extensive literature search identified randomized controlled trials, observational cohort studies and pharmacovigilance reports that investigated the safety of SGLT2is in patients with type 2 diabetes (T2D), with or without comorbidities or presenting at-risk conditions. EXPERT OPINION: Some adverse events pointed out initially have been confirmed, especially a higher risk of genital infections, though not the initial fear of urinary tract infections. A euglycemic diabetic ketoacidosis remains exceptional in patients with T2D. Volume depletion is a rare event that may be anticipated. Of note, several severe adverse events that led to warnings by regulatory agencies have not been confirmed in further studies: bone fractures, lower-limb amputations, severe perineal infections, acute renal injury. The safety profile of SGLT2is appears globally reassuring even in special at-risk populations. However, data remain rather scarce in patients with severe comorbidities and in very old or frail people, so that caution use is classically recommended.
Bridging evidence gaps in dravet syndrome: real-world safety insights from under-reported antiseizure therapies.
Ferretti A, Riva A, Perilli L … +2 more , Parisi P, Striano P
Expert Opin Drug Saf · 2026 Apr · PMID 42033134 · Publisher ↗
INTRODUCTION: Dravet syndrome is an early-onset developmental and epileptic encephalopathy in which management must extend beyond seizure control to include the monitoring and treatment of neurodevelopmental and systemic...
INTRODUCTION: Dravet syndrome is an early-onset developmental and epileptic encephalopathy in which management must extend beyond seizure control to include the monitoring and treatment of neurodevelopmental and systemic comorbidities. AREAS COVERED: Well-established treatments, together with recently approved agents, are discussed alongside under-reported therapies. Safety profiles, clinically relevant pharmacokinetic interactions, and practical aspects of dose titration and monitoring are reviewed. Emerging targeted pharmacological and genetic strategies are also briefly considered as potential disease-modifying approaches. EXPERT OPINION: In clinical practice, valproate-based regimens remain central to seizure management, with adjunctive therapies tailored to seizure type, comorbidities, tolerability, and drug interactions. While stiripentol, clobazam, fenfluramine, and cannabidiol are supported by the strongest evidence, less frequently reported therapies, including perampanel, topiramate, levetiracetam, cenobamate, and ketogenic dietary therapies, may benefit selected patients but require cautious use due to heterogeneous efficacy and safety data. The complexity of available options highlights the need for individualized, dynamic treatment strategies. Although emerging targeted and genetic therapies may represent a future paradigm shift beyond symptomatic seizure control, their clinical impact remains to be established, warranting careful implementation and long-term safety evaluation.
The efficacy and safety of antithrombotic drug options in acute ischemic stroke.
Laudisi M, Ferri C, Pugliatti M … +1 more , Paciaroni M
Expert Opin Drug Saf · 2026 Apr · PMID 42011767 · Publisher ↗
INTRODUCTION: Acute ischemic stroke (AIS) is currently the leading cause of morbidity and mortality globally, and despite progress that has been made in treatment and prevention over the last 30 years, its burden is expe...
INTRODUCTION: Acute ischemic stroke (AIS) is currently the leading cause of morbidity and mortality globally, and despite progress that has been made in treatment and prevention over the last 30 years, its burden is expected to increase in future decades, due to the growth and aging of the populations. Therein, a greater access and delivery of safe and effective better drugs will be needed to improve AIS management. AREAS COVERED: This review highlights the current AIS care strategies, focusing on the efficacy and safety of antithrombotic drugs. EXPERT OPINION: Regarding AIS, reperfusion through IV thrombolysis remains the cornerstone of treatment, alongside mechanical thrombectomy in eligible patients. International guidelines recommend Alteplase within 4.5 hours of symptom onset; however, advanced neuroimaging may allow for the extension of this treatment window in selected patients. Tenecteplase, with its favorable pharmacokinetics and simplified administration, is emerging as an alternative. Early secondary prevention is strictly dependent on stroke etiology and consists of antiplatelets, oral anticoagulants, and aggressive risk factor control. Cardioembolic strokes require timely oral anticoagulation, while noncardioembolic minor ischemic strokes or high-risk transient ischemic attacks benefit from short-term dual antiplatelet therapy.
A novel, widespread impurity in mass-compounded tirzepatide/B12 products: potential patient safety implications.
Jordan B, Arbogast L, Clemens M … +2 more , Huang L, Snyder M
Expert Opin Drug Saf · 2026 May · PMID 42010938 · Publisher ↗
BACKGROUND: Compounded versions of tirzepatide are widely available in the U.S. in the form of fixed‑dose combinations of tirzepatide and various analogs of vitamin B12. These combinations are mass marketed in the U.S. a...
BACKGROUND: Compounded versions of tirzepatide are widely available in the U.S. in the form of fixed‑dose combinations of tirzepatide and various analogs of vitamin B12. These combinations are mass marketed in the U.S. and other countries as comparable to FDA‑approved tirzepatide products even though they undergo no evaluation of their potency or impurity profiles. RESEARCH DESIGN AND METHODS: Samples of compounded tirzepatide combined with B12 obtained from various sources in the U.S. market were tested using various analytical methods. Samples were assessed for unacceptable levels of peptide-related impurities. RESULTS: Our testing identified a widespread and previously unidentified impurity in compounded tirzepatide-B12 products resulting from a chemical reaction between tirzepatide and certain analogs of B12. CONCLUSION: Despite the presence of this impurity, these products continue to be mass marketed as 'personalized' treatments. Our findings underscore the importance of testing and FDA approval before new drugs are marketed and highlight potential risks for patients associated with untested combinations. A novel impurity, present at substantial levels in compounded tirzepatide/B12 products, highlights risks inherent in marketing complex therapies outside the drug‑approval framework. Although clinical effects of this impurity are unknown, the identification of a widespread impurity adds to the existing quality concerns presented by compounded tirzepatide.
Refractory immune-related adverse events (irAEs) associated with immune checkpoint inhibitor therapy: a multiorgan management review.
Moura MJ, Chatterjee A, Wali S … +20 more , Garza DR, Salim H, Rong J, Menon R, Jafri F, Urias Rivera A, Mortan R, Palaskas NL, Reynolds KL, Leaf RK, Kikani N, Thomas A, Zhang HC, Wang LS, Tummala S, Al-Zubidi N, Sheshadri A, Abudayyeh A, Jeff YL, Wang Y
Expert Opin Drug Saf · 2026 Apr · PMID 41995025 · Publisher ↗
INTRODUCTION: Immune checkpoint inhibitors (ICIs) have transformed the treatment of multiple malignancies and significantly increased survival; however, by enhancing antitumor immunity, they can also cause off-target imm...
INTRODUCTION: Immune checkpoint inhibitors (ICIs) have transformed the treatment of multiple malignancies and significantly increased survival; however, by enhancing antitumor immunity, they can also cause off-target immune-related adverse events (irAEs), some of which become refractory to standard first-line corticosteroids. Refractory irAEs (r-irAEs) require timely recognition and personalized, organ-specific escalation strategies based on toxicity severity and mechanistic insights. AREAS COVERED: In this narrative review, we synthesize current evidence across organ systems on the epidemiology, clinical features, diagnostic evaluation, and management of r-irAEs, with a particular focus on second- and third-line immunosuppressive options. We summarize findings from retrospective cohorts, prospective studies, guideline statements, and high-quality case series relevant to steroid-refractory irAEs and highlight practical considerations for escalation. The literature search was performed in PubMed and Embase for publications from January 2010 through August 2025. EXPERT OPINION: Tailored treatment strategies and structured escalation algorithms are needed to optimize outcomes for patients with r-irAEs. Integration of emerging biomarkers, endoscopic and histologic findings, and tumor microenvironment features may facilitate earlier recognition of steroid-refractory disease and more individualized escalation of immunosuppression.
Long-term safety and effectiveness of vonoprazan as maintenance therapy for reflux esophagitis in Japan: a 12-month post-marketing surveillance study.
Manabe N, Matsuo M, Suzuki C
Expert Opin Drug Saf · 2026 Apr · PMID 41982134 · Publisher ↗
BACKGROUND: This study aimed to assess the safety and effectiveness of vonoprazan, a potassium-competitive acid blocker, as long-term maintenance therapy in patients with healed reflux esophagitis (RE) in real-world sett...
BACKGROUND: This study aimed to assess the safety and effectiveness of vonoprazan, a potassium-competitive acid blocker, as long-term maintenance therapy in patients with healed reflux esophagitis (RE) in real-world settings. RESEARCH DESIGN AND METHODS: This prospective, observational study enrolled patients with healed RE from 122 sites in Japan. Patients received daily oral vonoprazan 10 mg as maintenance treatment for 12 months. Safety was assessed by monitoring adverse events (AEs) and adverse drug reactions (ADRs), and effectiveness was evaluated by endoscopic RE recurrence and symptom severity. RESULTS: Of the 1237 enrolled patients, 1174 were included in the safety analysis. ADRs were reported in 2.3% of patients. ADRs included diarrhea, constipation, and abnormal hepatic function. The severity of symptoms improved over time, and of those with endoscopic findings, the RE recurrence was 4.0% (17/425). A total of four serious ADRs were reported in two patients, which led to death, comprising pneumonia, acute leukemia, myelodysplastic syndrome, and decreased platelet count. CONCLUSIONS: This study demonstrates the effectiveness of vonoprazan in preventing RE recurrence during maintenance treatment in clinical practice. The incidence of ADRs was low, and no new safety signals were identified, supporting the established safety profile of vonoprazan. NCT03214081; jRCT1080223147.
Safety and efficacy of currently used drug therapies for treatment of lymphomas in patients with Sjögren's disease, a scoping review.
Suludere MA, Alberga JM, Verstappen G … +5 more , van der Vegt B, Nijland M, Vissink A, Bootsma H, Delli K
Expert Opin Drug Saf · 2026 Apr · PMID 41954210 · Publisher ↗
INTRODUCTION: Sjögren's disease (SjD) carries an increased risk of B-cell lymphoma, yet drug treatment strategies are largely extrapolated from general lymphoma care. This study summarizes available evidence on the effic...
INTRODUCTION: Sjögren's disease (SjD) carries an increased risk of B-cell lymphoma, yet drug treatment strategies are largely extrapolated from general lymphoma care. This study summarizes available evidence on the efficacy and safety of drug therapies in SjD-associated lymphomas. AREAS COVERED: A PubMed and Embase search (January 1995-August 2025) identified studies evaluating the efficacy and safety of pharmacologic treatment for SjD-associated non-Hodgkin B-cell lymphomas (English language, ≥5 patients). Rituximab (anti-CD20) monotherapy achieved reliable early disease control in localized, low-burden lymphoma with limited toxicity. In more disseminated or aggressive lymphoma types, particularly diffuse large B-cell lymphoma, immunochemotherapy (rituximab plus chemotherapy) remains standard. In indolent disease, immunochemotherapy combination regimens can improve lymphoma control. However, regimen-specific safety data are limited and inconsistently reported. EXPERT OPINION: Current evidence supports a pragmatic, individualized approach. Rituximab remains the foundation of SjD-associated lymphoma therapy, typically combined with chemotherapy. However, current evidence is limited by small, heterogeneous cohorts, with pooled reporting across lymphoma types/regimens and limited safety reporting. Prospective SjD-specific studies, with regimen-level reporting of efficacy and safety are needed. Uniform endpoints that capture both hematologic and autoimmune activity, and lymphoma-type stratification should be applied.
Safety concerns associated with various types of statins: a disproportionality analysis of the FAERS database.
Zeng Y, Tian X, Jiang J … +7 more , Pan W, Liu B, Dai D, Zhou L, Zeng W, Chen Y, Liu J
Expert Opin Drug Saf · 2026 Apr · PMID 41931115 · Publisher ↗
INTRODUCTION: Statins' widespread use in cardiovascular disease management raises concerns about adverse drug reactions (ADRs). Comparative ADR profiles across different statin types remain lacking, necessitating further...
INTRODUCTION: Statins' widespread use in cardiovascular disease management raises concerns about adverse drug reactions (ADRs). Comparative ADR profiles across different statin types remain lacking, necessitating further investigation to refine patient management. AREAS COVERED: The FDA Adverse Event Reporting System (FAERS) database (2004Q1-2024Q2) was leveraged to extract healthcare professional reports where statins were the 'principal suspected' causative agent. A systematic analysis of ADRs for statins (Atorvastatin, Simvastatin, Rosuvastatin, Pravastatin, Lovastatin, Fluvastatin, Pitavastatin) was performed using Ratio of Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). Intersection analysis delineated similarities and differences in ADR profiles across various statin types. EXPERT OPINION: This study identified common ADRs across all statin types, including elevated Blood Creatine Phosphokinase, Chromaturia, and elevated Hepatic Enzymes. Furthermore, a shared ADR of elevated Blood Urea was observed across all statins except Pitavastatin. Specific ADRs, potentially attributable to their distinct pharmacokinetic properties and chemical structures, including hearing loss associated with Atorvastatin, skeletal-related ADRs with Rosuvastatin, and premature labor with Pravastatin. This pharmacovigilance study utilizing spontaneous reporting data revealed previously underrecognized statins safety signals. Findings suggest distinct reporting patterns among statins, warranting dedicated investigations into their clinical considerations.
Safe prescribing of antihypertensive drugs in the elderly and managing the risk of adverse events.
Passey S, Erum M, Patel N … +8 more , Chopra S, Jain H, Jha J, Kingma T, Kholoki O, Pillai A, Venkataramanan SVA, Aronow W
Expert Opin Drug Saf · 2026 Apr · PMID 41915803 · Publisher ↗
INTRODUCTION: Older patients with hypertension have unique clinical challenges based on age-related physiological changes, multimorbidity, and vulnerability to drug side effects. The 2017 American College of Cardiology/A...
INTRODUCTION: Older patients with hypertension have unique clinical challenges based on age-related physiological changes, multimorbidity, and vulnerability to drug side effects. The 2017 American College of Cardiology/American Heart Association guidelines propose initiating antihypertensive therapy at a systolic blood pressure threshold of 130 mm Hg for non-institutionalized ambulatory adults over the age of 65. They also recommended individualized treatment for adults with advanced frailty or high risk of adverse events. AREAS COVERED: This article reviews evolving paradigms and strategies in blood pressure therapy in elderly individuals, based on shifting the approach from stringent treatment targets toward individualized management. Step-care management is one such strategy that involves prudent introduction of low doses of antihypertensives with regular follow-up to avoid side effects. Deprescribing is increasingly being promoted as a key intervention in reducing polypharmacy and maximizing safety in at-risk groups of patients. EXPERT OPINION: There is an increased need to incorporate frailty and functional assessments into routine practice and clinical trials. Despite growing evidence, there are still implementation challenges such as insufficient robust long-term data for frail populations. Pragmatic trials, adoption of digital solutions, and implementation of individualized goals must be the targets of future research.
Insights gained from drug utilization research to improve safe clinical practice for children and adolescents in Denmark.
Kildegaard H, Pottegård A
Expert Opin Drug Saf · 2026 Apr · PMID 41910965 · Publisher ↗
INTRODUCTION: Drug utilization studies (DUS) provide important insights on how medications are used in routine clinical practice and can identify gaps between real-world use and existing evidence and guidance. While DUS...
INTRODUCTION: Drug utilization studies (DUS) provide important insights on how medications are used in routine clinical practice and can identify gaps between real-world use and existing evidence and guidance. While DUS are relevant across all therapeutic areas, they are particularly valuable in pediatrics as a substantial proportion of prescribing occurs off-label or with limited trial data. AREAS COVERED: This paper describes five domains where pediatric DUS can contribute to improving safe and rational use of medications: (i) setting research priorities, (ii) supporting drug surveillance and stewardship, (iii) identifying and reducing unwarranted variation, (iv) assessing prescriber behavior, and (v) evaluating the impact of regulatory actions and clinical guidelines. The five domains are illustrated using examples of Danish register-based pediatric DUS. EXPERT OPINION: Despite their value, pediatric DUS remain underused in clinical and regulatory decision-making. DUS should be systematically integrated into the development and revision of clinical guidelines on medication use and used routinely to evaluate the effects of major regulatory initiatives. Establishing near-real-time monitoring systems and extending DUS to inpatient settings would further strengthen their ability to impact clinical practice and support safer and more evidence-based prescribing for children and adolescents.
Cardiorenometabolic medicine as a new subspecialty in the light of novel pharmaceuticals with dual or triple benefits.
Medenica S, Prelević V, Zanković N … +2 more , Maggio V, Rizzo M
Expert Opin Drug Saf · 2026 Apr · PMID 41860010 · Publisher ↗
INTRODUCTION: There is a lack of clinical models which include comprehensive and holistic care of patients with cardiorenometabolic diseases and isolated care of those patients usually leads to poor clinical outcomes. Ca...
INTRODUCTION: There is a lack of clinical models which include comprehensive and holistic care of patients with cardiorenometabolic diseases and isolated care of those patients usually leads to poor clinical outcomes. Cardiometabolic diseases, encompassing conditions like type 2 diabetes, obesity, and atherosclerotic cardiovascular disease, represent a major global health burden. Their frequent coexistence due to shared mechanisms necessitates an integrated care approach, reflecting a critical paradigm shift. Therefore, necessity for a new integrated clinical model which include all those specialties should be the focus of a new, modern interdisciplinary approach. AREAS COVERED: This review synthesizes mechanistic insights, safety data, and emerging interventions for cardiorenometabolic disease management. It examines cornerstone therapies like SGLT2 inhibitors and GLP-1 receptor agonists, highlighting their profound cardiovascular, renal, and metabolic benefits. Newer dual/triple incretin therapies are also discussed for their potential in weight loss and cardioprotection. Safety considerations, including genitourinary infections and gastrointestinal intolerance, are addressed. Additionally, emerging research on gut microbiota-derived metabolites and sleep optimization as modifiable risk pathways is explored. The literature search included papers published as of July 2025, identified using PubMed. EXPERT OPINION: We advocate a holistic, risk-adapted approach integrating pharmacologic, behavioral, and metabolic dimensions to optimize patient outcomes and truly transform cardiometabolic care.
GLP-1-derived therapies and risk of sarcopenia: myth or reality?
Scheen AJ
Expert Opin Drug Saf · 2026 Mar · PMID 41851969 · Publisher ↗
INTRODUCTION: Glucagon-like peptide-1 (GLP-1)-based therapies elicit a clinically significant reduction in body weight, an effect that correlates with improved clinical outcomes in individuals with type 2 diabetes and/or...
INTRODUCTION: Glucagon-like peptide-1 (GLP-1)-based therapies elicit a clinically significant reduction in body weight, an effect that correlates with improved clinical outcomes in individuals with type 2 diabetes and/or obesity. However, a risk of excessive reduction in skeletal muscle mass (SMM), potentially leading to sarcopenia, could minimize the benefit/risk balance of this pharmacological class. AREAS COVERED: Human studies that investigated the effects of GLP-1-based therapies on changes in SMM, muscle strength/function and muscle structure/quality. EXPERT OPINION: Mixed results were reported, some studies emphasizing an excessive SMM loss while others not but arguing for a protective effect against sarcopenia through improved muscle quality (less myosteatosis). This controversy may stem from the misinterpretation of changes in body composition, as well as from the scarcity of studies that rigorously assess SMM, muscle function, and structure in humans. At present, no definitive conclusion can be drawn regarding the potential detrimental or beneficial effects of GLP-1-based therapies on skeletal muscle. Even if most available results are reassuring, further investigations are warranted, especially among individuals at higher risk of sarcopenia as older patients. In any case, the overall benefit/risk ratio of GLP-1-based therapies appears positive in most patients living with type 2 diabetes and/or clinical obesity.
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