Expert Opinion on Drug Safety最新文献

Introduction: Medical therapy is crucial in the long-term management of endometriosis, and its clinical efficacy must be balanced with a favorable safety profile.

Areas covered: This review aims to provide a comprehensive overview of available drugs for the treatment of endometriosis, with an emphasis on their safety. A literature search was conducted using MEDLINE. EMBASE. and the Cochrane Library. Reference lists of relevant articles and recent book chapters were also examined.

Expert opinion: First-line therapies include combined contraceptives and progestins, both effective in reducing pain. Combined contraceptives commonly cause breakthrough bleeding, nausea, headaches, breast tenderness, and libido changes. Progestins may lead to depression, decreased libido, weight gain, breast tenderness, and lipid alterations. Gonadotropin-releasing hormone agonists are second-line options but are limited by hypoestrogenic side effects, including vasomotor symptoms, urogenital atrophy, and bone mineral density (BMD) loss. Add-back therapy with norethindrone acetate or low-dose combined contraceptives mitigates these effects. GnRH antagonists provide immediate suppression without flare-up and may improve adherence; however, hot flushes and BMD loss remain concerns. While all hormonal therapies are suppressive rather than curative, optimizing safety and tolerability is essential for sustained use and symptom control.

Objective: By analyzing the signal mining of vandetanib AEs, it provides a reference for the rational clinical use of the drug.

Methods: This study provides signal detection and analysis of AEs associated with vandetanib using the FAERS from Q2 2011 to Q1 2023.

Results: Disproportionality analyses were conducted using the ROR and the MHRA method, with AEs categorized and described based on SOC and PT from the MedDRA. A total of 1,721 AEs reports identified vandetanib as the primary suspect. The analyses yielded 187 AEs signals across 20 SOCs categories, with 47 signals not previously reported in the vandetanib labeling. Additionally, the study analyzes factors influencing AEs. The results are as follows: There are significant differences in Investigations based on gender and nationality (p < 0.05); skin and subcutaneous tissue disorders and gastrointestinal disorders exhibit differences based on gender, age, and nationality (p < 0.05).

Conclusion: Common AEs signals identified align with those documented in the drug labeling. However, AEs such as tumor lysis syndrome, skin discoloration, and pigmentary disorders, which are not listed in the labeling, warrant special attention. It is essential that abnormalities in patients' skin and laboratory indicators are closely monitored and addressed promptly to safeguard medication safety.

Background: The primary objective of this research is to conduct an exhaustive evaluation of rimegepant with the Food and Drug Administration Adverse Event Reporting System (FAERS) repository.

Research design and methods: This study downloaded the reporting files related to rimegepant from the second quarter of 2020 to the first quarter of 2024. Disproportionality analysis was utilized to explore the relationship between rimegepant and adverse drug events (ADEs).

Results: This study analyzed 6659 ADE reports associated with rimegepant as the primary suspected (PS) drug. In the disproportionate analysis of system organ classes (SOCs), the significant signal for rimegepant was general disorders and administration site conditions.On the preferred terms level, 35 ADEs were identified following the exclusion. The top five ADEs with high signal strengths were medication overuse headache, nasal edema, tension headache, performance status decreased, and motion sickness. The most frequent ADEs were nausea, feeling abnormal, abdominal pain upper, somnolence, and hypersensitivity. In addition, we need to pay attention to the ADEs not mentioned in the instruction and clinically significant: vertigo, hyperacusis, somnolence, Raynaud's phenomenon, motion sickness, panic attack, and fear.

Conclusions: This study highlights previously unrecognized safety concerns associated with the use of rimegepant. These novel safety aspects suggest that while these treatments can be effective, additional risks may need further exploration.

Introduction: The integration of artificial intelligence (AI) into pharmacovigilance (PV) has advanced rapidly in recent years. AI tools have the potential to transform signal management by enabling faster and more accurate signal management and decision-making. However, the regulatory landscape governing these technologies remains complex.

Areas covered: This article presents available AI tools for signal management, provides an overview of the regulatory landscape of these tools, and explores stakeholder perspectives on the challenges and opportunities posed by AI regulations. On 23 July 2024, we conducted a Google search of the top 2,000 results using the query 'AI pharmacovigilance service provider.' Two searches were performed in Ovid MEDLINE to identify articles published between 1 January 2022, and 23 July 2024, using ad hoc queries.

Expert opinion: AI tools are now available to support all critical activities in signal management. However, regulatory discrepancies and variations persist across different regions. The findings underscore the urgent need for ongoing international collaboration to harmonize regulatory frameworks and ensure the safe and ethical implementation of AI in PV. As AI technologies continue to evolve, addressing these regulatory and operational challenges will be essential to fully realize their potential in enhancing drug safety and improving healthcare outcomes worldwide.

Background: Panitumumab has been extensively applied in antitumor therapy, and the regulation of its adverse drug reactions (ADRs) has become extremely important. This study utilized the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database to extract real-world panitumumab ADR signals and provide relevant information for drug safety.

Research design and methods: ROR, PRR, BCPNN, and MGPS were used to identify real-world ADR signals associated with panitumumab.

Results: Analysis of 9,033 patients identified 263 ADR signals across 20 MedDRA System Organ Classifications. New signals including peripheral sensory neuropathy, gene mutation, decreased neutrophil count, polyneuropathy, ileus, neutropenia, and febrile neutropenia. Age and sex subgroup analyses revealed specific risks, such as polyneuropathy and gene mutation in those under 65 years of age, decreased neutrophil count and peripheral sensory neuropathy in those over 65 years of age, and febrile neutropenia in men. Ileus was highlighted as a novel ADR in gastrointestinal disorders, with no significant age or sex differences.

Conclusion: This study identified new signals of ADR associated with panitumumab, providing valuable information for the clinical use of panitumumab.

Background: The increasing prevalence of statin use for cardiovascular disease management has raised concerns regarding their safety profile, particularly regarding the potential risk of diabetes. Our study aims to analyze diabetic adverse event reports related to statins using a large pharmacovigilance database to provide timely insights into this significant issue.

Methods: We analyzed data from the FDA Adverse Event Reporting System (FAERS) database from 2004 to 2023. Disproportionality analyses were performed to detect signals of diabetic adverse events associated with the three most commonly prescribed statins: atorvastatin, rosuvastatin, and simvastatin.

Results: We identified 11,364 cases of statin-related diabetic adverse events across the three statins. Disproportionality analyses revealed a significant association between these statins and four specific diabetic adverse events: type 2 diabetes mellitus, impaired glucose tolerance, diabetic neuropathy, and diabetic retinal edema. Notable sex differences emerged, with females exhibiting an overall significantly higher propensity for diabetes-related adverse events.

Conclusions: Our study is timely and relevant as it addresses growing concerns about the safety of widely prescribed statins and their association with diabetes. By highlighting these critical issues, the study seeks to contribute valuable insights to practitioners, ultimately guiding better clinical practices and enhancing pharmacovigilance efforts.

Introduction: Bimekizumab is the latest biologics approved for the management of moderate-to-severe plaque psoriasis. Its unique mechanism of action simultaneously inhibition of interleukin (IL)17A and IL17F] offers a potentially deeper suppression of cutaneous immune activation compared to selective IL17A inhibition alone. While clinical trials demonstrated excellent results in terms of efficacy and safety, real-world data are mandatory to assess its performance in broader patient populations, including those excluded from trials.

Areas covered: This narrative review summarizes findings from real-life studies on bimekizumab in moderate-to-severe plaque psoriasis. Extensive literature research was conducted on the main databases, including PubMed, Embase, Ovid, Scopus, Google Scholar and the Cochrane Library, until April 2025.

Expert opinion: Bimekizumab has rapidly gained relevance as a highly effective and fast-acting option in psoriasis management, with durable outcomes across heterogeneous patient profiles. The emerging number of real-world evidence reinforces its value in routine practice and supports its positioning as a valuable weapon among the armamentarium of biological therapies.

Background and aims: Data related to clinical characteristics and potential mechanisms of proton pump inhibitors (PPIs)-related liver injury are sparse, thus the purpose of this study is to summarize the clinical features and molecular mechanisms of PPIs-induced liver injury.

Methods: We collected case report on liver injury induced by PPIs in English and Chinese for retrospective analysis. Clinical and pathological data and outcomes were obtained and analyzed. Network pharmacology and molecular docking techniques were employed to examine the mechanism.

Result: Twenty-three patients with PPIs-induced liver injury were enrolled. PPIs-induced liver injury is a rare adverse reaction, ranging from asymptomatic elevated transaminases to fulminant liver failure. Omeprazole was the drug with the highest number of associated reports. The most common symptom was fatigue. The most common liver injury pattern was hepatocellular injury. A total of 13 intersection targets of PPIs and liver injury were screened, and the top 10 targets were included, and the PI3K-Akt signaling pathway was significantly enriched. The results of molecular docking implied that the PPIs could combine well with key targets.

Conclusion: Patients receiving long-term treatment with PPIs should consider monitoring liver function. PPIs exhibit considerable capacity in liver injury via especially the PI3K-Akt signaling pathway.

Background: Tezepelumab is the first asthma biologic approved by the FDA that is not restricted by biomarker phenotypes. To date, there have been no studies reporting adverse events (AEs) associated with the real-world use of tezepelumab.

Research design and methods: This study included a comprehensive evaluation of AE reports related to tezepelumab since its approval (4th quarter of 2021 to 1st quarter of 2024) using the FAERS database, and compared with the currently reported clinical trial results (ClinicalTrials.gov).

Results: A total of 2153 reports of tezepelumab-related AEs were extracted. 256 preferred terms (PTs) of adverse reactions involving 27 system organ classes were identified. Significant AEs that were not reported on the drug label, such as 'dyspnea,' 'body temperature,' and 'tongue pruritus,' were reported. The median time to onset (TTO) of tezepelumab-related AEs was 35 days.The most frequent AEs in different sexes were 'arthralgia' and 'dyspnea,' with differences in signal strength ranking between the sexes.

Conclusions: This study represents the largest report to date on tezepelumab-related AEs, providing valuable insights into the potential side effects of tezepelumab. This work is crucial for the broader clinical application of this novel biologic and improving outcomes for patients with severe asthma.

Introduction: Atorvastatin, one of the most widely used drugs, has attracted controversy regarding its potential adverse reactions to acute kidney injury(AKI). This study aims to provide evidence in support of the safe use of atorvastatin.

Areas covered: Reports with atorvastatin as the primary suspect drug were extracted from the FDA Adverse Event Reporting System (FAERS) and categorized into five groups: general population, acute myocardial infarction (AMI), ischemic stroke (IS), type 2 diabetes mellitus (T2DM), and hyperlipidemia (HLD). We conducted subgroup analyses by gender and age, using four standards-ROR, PRR, BCPNN, and EGBM-to perform disproportionality analysis and assess positive signals. Statistical analysis evaluated differences between the occurrence and non-occurrence of adverse drug reactions (ADRs), as well as differences between high and low induction time groups.

Expert opinion: In the general population, evidence for a positive AKI signal was insufficient. However, subgroup analysis showed risk in males and older individuals in AMI and IS populations, while younger age groups in T2DM showed positive signals. In the HLD population, evidence was insufficient across genders and ages. Atorvastatin is generally safe, but clinical vigilance for AKI is needed in T2DM, AMI, and IS populations, especially in those 65 and older.