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    Expert opinion on drug safety

    Expert opinion on drug safety

    JournalISSN 1474-0338eISSN 1744-764X中科院 医学 3区

    年发文量

    研究主题

    论文(3156)

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    1Safety of Treatments for Children with Functional Constipation.
    Tirza M van Os,Megan A Read,Richard J Wood,Carlo Di Lorenzo,Marc A Benninga,Peter L Lu

    INTRODUCTION:Functional constipation (FC) in children is a common diagnosis that can be challenging to treat effectively. Internet and social media are shaping parental knowledge and beliefs has become of great importance. AREAS COVERED:A literature review was conducted by searching electronic databases (inception-April 2026) for studies on safety of current management options for FC in children. Our main goal was to describe safety and patients' and parents' satisfaction regarding pharmacological, neuromodulation and surgical therapies. We also addressed myths commonly shared by the lay public. Current evidence supports osmotic and stimulant laxatives as safe first-line treatments for pediatric FC. More novel therapies such as secretagogues and noninvasive neuromodulation may shift management in the future, but long-term safety data regarding these treatments need to be collected. Surgical options are reserved for refractory cases due to complication risks. EXPERT OPINION:Emphasizing safety and addressing misconceptions are essential in order to improve treatment adherence. The availability of more therapeutic options highlights the need for patient stratification to maximize benefit and minimize adverse effects. The growing influence of social media on caregivers underscores the importance of evidence-based communication and shared decision-making in clinical practice.

    2026
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    2Lesser-known Medication Safety Considerations in Sickle Cell Disease.
    Najbah Galadanci,Julie Kanter

    INTRODUCTION:Sickle cell disease (SCD) is a clinically heterogeneous condition in which individuals experience markedly different disease trajectories. As more people with SCD now survive to adulthood, their disease becomes more complicated due to comorbidities, both related and unrelated to SCD. Thus, a precision-oriented approach is essential when initiating new treatments to ensure the delivery of meaningful and sustained benefits for people with SCD. AREAS COVERED:This expert review examines selected, underrecognized safety concerns related to disease-modifying therapies for SCD as well as for other medications often used in this population. We discuss examples of safety issues involving SCD-modifying therapies, cardiovascular and renal medications, antibiotics, and corticosteroids, highlighting how the unique pathophysiology of SCD may influence drug safety, tolerability, and organ injury. The review is based on a narrative assessment of published clinical trials, observational studies, post-marketing safety reports, registry data, and expert clinical experience. EXPERT OPINION:Although SCD is recognized as a highly heterogeneous condition, this issue is not consistently considered in clinical trial design or when using non-SCD therapies in this population. The recent emergence of new drugs emphasizes the importance of longitudinal monitoring, real-world safety assessment, and multidisciplinary specialist care.

    2026
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    3Myositis in Cancer Patients Receiving Immune Checkpoint Inhibitors: the ARON-MOUSEION-017 Systematic Review and Meta-Analysis
    Elsa Vitale,Gerardo Cazzato,Lorenza Maistrello,Mario Della Mura, Mauro Francesco Pio Maiorano, Francesco Ciccimarra,Oronzo Brunetti, Concetta Calabrò, Brigida Anna Maiorano, Fernando Sabino Marques Monteiro, Enes Erul,Francesco Massari,

    BACKGROUND:Myositis may present as a treatment-related adverse event (TRAE) during immune checkpoint inhibitor (ICI) therapy. In the ARON-MOUSEION-017 meta-analysis, we aimed to assess the frequency of myositis among cancer patients treated with ICIs. RESEARCH DESIGN AND METHODS:The present systematic review and meta-analysis was registered in PROSPERO with ID no. CRD420261278193. Embase, PubMed, Scopus and Web of Science databases were consulted, using Boolean terms and keywords 'Immunotherapy,' 'Myositis' and 'Neoplasms.' RESULTS:For myositis of any grade, 13 studies were included, suggesting that heterogeneity across studies was high and statistically significant (p < 0.001; τ2 = 3.78; I2 = 95.3%, 95% CI [93.1%; 96.7%]), and the pooled proportion of patients affected by any-grade myositis treatment-related adverse events (TRAEs) was 4.2% (95% CI = [1.1%; 14.6%]). CONCLUSIONS:ICI-myositis often appears in concomitance with other immune-mediated conditions, such as myocarditis and myasthenia gravis. These events are clinically relevant, since they are often associated with more severe disease courses and unfavorable outcomes, increasing morbidity and mortality.

    2026
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    4Long-term Efficacy and Safety of Intra-Articular Corticosteroid Injections in Patients with Knee Osteoarthritis.
    Aricia J Thirumaran, David J Hunter

    INTRODUCTION:Knee osteoarthritis (KOA) is a highly prevalent condition worldwide, resulting in a significant symptom burden and diminished quality of life. Mainstays of KOA management include weight loss, exercise, physical activity, and simple analgesia, with joint replacement as a last resort. Intra-articular injections, especially corticosteroids, have been increasingly used to provide symptomatic relief when simple analgesia fails. However, the efficacy and safety of intra-articular corticosteroid injections (IACS) remain poorly established. AREAS COVERED:This narrative literature review will evaluate the current available literature, outlining evidence on the use of IACS in KOA as well as its clinical efficacy, safety, adverse effects and potential alternative injections. Articles included were sourced from the University of Sydney Library database, Medline via Ovid, and Scopus, between 2000 and 2026. EXPERT OPINION:Overall, while IACS may only provide short-term pain relief, evidence suggests that long-term use should be avoided to prevent chondrotoxicity and further progression of osteoarthritis.

    2026
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    5Safety of Janus Kinase Inhibitors in Patients with Moderate-to-severe Atopic Dermatitis: a Systematic Review and Meta-Analysis of Observational Studies.
    Mei Li, Jianing Ni,Lian Zhang,Can Chen, Jingjing Ye,Ninggang Chen

    INTRODUCTION:We conducted a systematic review and meta-analysis to evaluate real-world safety outcomes associated with Janus kinase (JAK) inhibitors in patients with moderate-to-severe atopic dermatitis (AD). METHODS:PubMed, Embase, Cochrane Library, and CINAHL were searched through April 2025. Two independent reviewers screened studies and extracted data according to predefined criteria. Risk of bias was assessed using Agency for Healthcare Research and Quality tools. RESULTS:The pooled incidence rates of adverse events (AEs) and serious adverse events (SAEs) with JAK inhibitors were 0.42 (95% CI: 0.35-0.50) and 0.03 (95% CI: 0.01-0.05), respectively. The most common AEs included acne (effect size [ES] = 0.14, 95% CI: 0.12-0.16), skin and subcutaneous tissue infections (ES = 0.17, 95% CI: 0.09-0.26), and herpes virus infections (ES = 0.07, 95% CI: 0.06-0.09). Compared with anti - interleukin-4/interleukin-13 inhibitors, JAK inhibitors were associated with higher risks of acne, anemia, and creatine kinase elevations. CONCLUSIONS:AEs were common but predominantly mild to moderate. Infections, particularly skin and subcutaneous tissue and herpes virus infections, were among the most frequently reported events. The pooled incidence of SAEs, including cardiovascular events, was low within reported follow-up periods. However, heterogeneity and relatively short follow-up limit conclusions regarding long-term risk. PROTOCOL REGISTRATION:CRD42025634423.

    2026
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    高被引作者

    作者引用发文
    Joseph T. Hanlon16241
    Emily Hajjar16241
    Robert Maher16241
    Dimitri P. Mikhailidis8357
    Roger McIntyre72126
    Wilbert S. Aronow69411
    Michael Davidson6943
    Giuseppe Murdaca68713
    Francesco Puppo68612
    Manfredi Rizzo67514

    高产作者

    作者引用发文
    Roger McIntyre72126
    Icilio Cavero43324
    Peter Giannoudis40418
    Annalisa Capuano39317
    Maurizio Sessa27915
    Scavone Cristina23114
    Jessurun Naomi6414
    Rafaniello Concetta38114
    Manfredi Rizzo67514
    Sportiello Liberata38314

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