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Hashimoto’s encephalopathy presenting as Wernekinck commissure syndrome: A case report

Xiaojia Tang, Xiaojie Liu, Jian Jing, Li Jiang, Peipei Liu, and Yingzhu Chen

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Volume 41 (2022) p. 128 - 134

Abstract

Clinical Neuropathology, Vol. 41 – No. 3/2022 (128-134)

Hashimoto’s encephalopathy presenting as Wernekinck commissure syndrome: A case report

Xiaojia Tang¹*, Xiaojie Liu²*, Jian Jing², Li Jiang², Peipei Liu², and Yingzhu Chen²

¹Department of Rehabilitation Medicine, Northern Jiangsu People’s Hospital Affiliated to Yangzhou University, and ²Department of Neurology, Clinical Medical College, Yangzhou University, Yangzhou, Jiangsu, China
The Wernekinck commissure syndrome is extremely rare in a clinical setting. This condition has been previously reported in association with midbrain infarction, midbrain hemorrhage, demyelinating pseudotumor, and optic neuromyelitis spectrum disease, but not with Hashimoto’s encephalopathy. Herein, we report the case of a 44-year-old hypertensive man who developed cerebellar ataxia, internuclear ophthalmoplegia, and cognitive decline. Magnetic resonance imaging (MRI) of the brain revealed brain stem damage involving Wernekinck commissure. Initially, this patient was diagnosed with acute midbrain infarction in another hospital. However, his symptoms did not improve after the administration of anti-platelet aggregation drugs, statin, and free radicals scavenging treatment. Re-examination of cranial MRI revealed abnormal signals in the left parietal lobe. After a series of investigations that excluded cerebral infarction and neurodegenerative diseases, Hashimoto’s encephalopathy was finally diagnosed. The patient’s symptoms improved remarkably after treatment with methylprednisolone and γ-globulin. To the best of our knowledge, there are no other reports on the onset of Wernekinck commissure syndrome in the clinical manifestations of Hashimoto’s encephalopathy.

*Equal contribution and co-first authors.Correspondence to:
Yingzhu Chen, PhD
or
Peipei Liu, PhD
Department of Neurology
Clinical Medical College, Yangzhou University
Yangzhou, Jiangsu 225001, China
Email: [email protected]; [email protected]

Original

Phase IV safety evaluation of voclosporin in lupus nephritis patients using the FAERS database for a 42-month period (2021 – 2024) 

Bo Gu, Bing Lv, and Jia Tang

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Volume 63 (2025) p. 518 - 529

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 63 – No. 11/2025 (518-529)

Phase IV safety evaluation of voclosporin in lupus nephritis patients using the FAERS database for a 42-month period (2021 – 2024) 

Bo Gu¹, Bing Lv², and Jia Tang³

¹Department of Anesthesiology, The Central People’s Hospital of Siping City, Siping, ²Department of Emergency, The First Hospital of Jilin University, Changchun, Jilin Province, and ³Department of Dermatology, Suining Central Hospital, Chuanshan District, Suining, Sichuan Province, China
Objective: Voclosporin, a novel calcineurin inhibitor (CNI), was FDA-approved in 2021 for treating lupus nephritis (LN). However, post-marketing studies and reports on adverse events (AEs) associated with voclosporin remain limited. This study analyzes voclosporin-associated AEs using FDA Adverse Event Reporting System (FAERS) data.
Materials and methods: AEs with voclosporin as the primary suspected (PS) drug were extracted from the FAERS database, covering the period from the first quarter of 2021 to the second quarter of 2024. Disproportionality analysis, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS), was used to analyze AE signals.
Results: We identified 3,785 reports of AEs associated with voclosporin as PS, encompassing a total of 10,795 AEs. After applying 4 disproportionality algorithms, 6 system organ classes (SOCs) and 88 preferred terms (PTs) were detected, respectively. AEs with the strongest signal intensities included: glomerular filtration rate decreased, urine protein/creatinine ratio increased, hypertension, diarrhea, headache, and blood potassium increased. The median onset time for AEs was 56 days (interquartile range 4 – 208 days), with ~ 43% of AEs occurring within the first month of commencing voclosporin therapy.
Conclusion: Our findings are consistent with AEs reported in previous clinical trials and outlined in the drug’s labeling. The study results further confirm the reliability of the adverse reactions listed in the prescribing information.Correspondence to:
Jia Tang, Master of Dermatology, Resident Physician
Department of Dermatology, Suining Central Hospital
No. 127 West Desheng Road
Chuanshan District, Suining 629000, Sichuan Province, China
Email: [email protected]

Original

The guanylate cyclase stimulator vericiguat: Insights and adverse events from a FAERS-based pharmacovigilance study 

Jia Tang, Bing Lv, Jingchun Han, Kehan Li, Qianying Li, and Yuan Hu

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Volume 64 (2026) p. 144 - 153

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 64 – No. 3/2026 (144-153)

The guanylate cyclase stimulator vericiguat: Insights and adverse events from a FAERS-based pharmacovigilance study 

Jia Tang¹, Bing Lv², Jingchun Han², Kehan Li¹, Qianying Li¹, and Yuan Hu¹

¹Department of Dermatology, Suining Central Hospital, Suining, Sichuan Province, and ²Department of Emergency, The First Hospital of Jilin University, Changchun, Jilin Province, China 
Background: Since its approval by the U.S. Food and Drug Administration in January 2021, vericiguat, a novel soluble guanylate cyclase stimulator, has been increasingly utilized in the treatment of heart failure with reduced ejection fraction. However, comprehensive long-term safety data on vericiguat in large populations are lacking.
Objective: This study analyzed the adverse events reported to the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to assess the safety profile of vericiguat.
Materials and methods: We selected four algorithms to evaluate the signals of adverse events related to vericiguat: Multi-item Gamma Poisson Shrinker, Bayesian Confidence Propagation Neural Network, Proportional Reporting Ratio, and Reporting Odds Ratio.
Results: We conducted a retrospective analysis of the FAERS database from January 19, 2021, to December 31, 2024, encompassing 6, 981, 085 reports. Among these, 1,863 adverse events from 886 reports were identified with vericiguat as the primary suspect. After applying all four algorithms at the preferred term level, 64 preferred terms were recognized, encompassing 853 signals. The most common adverse events, such as hypotension, dizziness, dyspepsia, and anemia, were consistent with findings of clinical trials. Additionally, we identified new adverse events, including gastrointestinal hemorrhage and renal impairment.
Conclusion: Our analysis provides a comprehensive safety assessment of vericiguat. Most of these results align with findings from previous studies. In addition, our data revealed several new adverse events. This study provides valuable insights that can inform future research and clinical practice.Correspondence to:
Yuan Hu
Master of Dermatology, Resident Physician
Department of Dermatology
Suining Central Hospital
No. 127 West Desheng Road,
Chuanshan District, Suining 629000,
Sichuan Province, China
Email: [email protected]

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