{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T14:27:15Z","timestamp":1788532035030,"version":"build-2803163510"},"reference-count":29,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"20","license":[{"start":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T00:00:00Z","timestamp":1778803200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2026,5,15]]},"abstract":"<jats:p>Foscarbidopa\/foslevodopa, a 24-hour subcutaneous infusion of levodopa\/carbidopa prodrugs, is approved for advanced Parkinson disease with motor fluctuations. Due to limited post-marketing data, the association between this novel formulation and related adverse events (AEs), particularly infusion-related or neurological complications, remains underexplored. This study aims to identify potential safety signals of foscarbidopa\/foslevodopa-associated AEs using data mining of the FDA Adverse Event Reporting System (FAERS). To quantify safety risk signals of foscarbidopa\/foslevodopa, disproportionality analyzes were conducted using the reporting odds ratio and Bayesian Confidence Propagation Neural Network methods, based on FAERS data from the last quarter of 2024 (2024Q4) to the second quarter of 2025 (2025Q2). Signal thresholds were strictly defined, and sensitivity analyses were performed to verify the robustness of results; subgroup analyses were conducted to explore sex differences and severity-related characteristics of AEs. The FAERS recorded 7527 foscarbidopa\/foslevodopa-related AEs affecting 1914 patients. A total of 1616 patients experienced serious AEs, including 265 deaths. The most frequently reported AEs were on and off phenomenon (n\u2005=\u2005223), fall (n\u2005=\u2005195), hallucination (n\u2005=\u2005156), and dyskinesia (n\u2005=\u2005132). Potential safety signals were detected, such as on and off phenomenon, hallucination, and infusion site infection. Notably, FAERS data are subject to spontaneous reporting bias, missing information, and lack of denominator exposure data, so the above results only reflect statistical associations rather than definite causal relationships. FAERS data identify potential clinically significant associative AEs with foscarbidopa\/foslevodopa, such as infusion site reactions and infections and hallucination. These findings support the need for enhanced monitoring of high-risk patients (e.g., mental and behavioral disorders, skin disorders) and reinforce the importance of real-world surveillance for novel Parkinson disease therapies. All findings are hypothesis-generating and require further clinical validation to confirm causal relationships.<\/jats:p>","DOI":"10.1097\/md.0000000000048874","type":"journal-article","created":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T02:01:42Z","timestamp":1778896902000},"page":"e48874","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":2,"title":["Post-marketing safety concerns with foscarbidopa\/foslevodopa: A pharmacovigilance study with disproportionality analysis based on FAERS"],"prefix":"10.1097","volume":"105","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-5621-0349","authenticated-orcid":false,"given":"Yuchen","family":"Peng","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Central Hospital of Dalian University of Technology, Dalian, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aili","family":"Ding","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Central Hospital of Dalian University of Technology, Dalian, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shihong","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Central Hospital of Dalian University of Technology, Dalian, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fanli","family":"Kong","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Central Hospital of Dalian University of Technology, Dalian, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ling","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Central Hospital of Dalian University of Technology, Dalian, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weijia","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Central Hospital of Dalian University of Technology, Dalian, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhengwu","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Central Hospital of Dalian University of Technology, Dalian, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinkuo","family":"Zheng","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Central Hospital of Dalian University of Technology, Dalian, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yalin","family":"Xi","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Central Hospital of Dalian University of Technology, Dalian, China."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"R1-20260904","doi-asserted-by":"crossref","first-page":"621","DOI":"10.1007\/s40263-025-01179-3","article-title":"Foslevodopa\/foscarbidopa: a review in advanced parkinson\u2019s disease.","volume":"39","author":"Blair","year":"2025","journal-title":"CNS Drugs"},{"key":"R2-20260904","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1002\/ana.26073","article-title":"Foslevodopa\/foscarbidopa: a new subcutaneous treatment for parkinson\u2019s disease.","volume":"90","author":"Rosebraugh","year":"2021","journal-title":"Ann Neurol"},{"key":"R3-20260904","doi-asserted-by":"crossref","first-page":"1349","DOI":"10.1007\/s00702-023-02693-8","article-title":"Current and novel infusion therapies for patients with Parkinson\u2019s disease.","volume":"130","author":"Antonini","year":"2023","journal-title":"J Neural Transm (Vienna)"},{"key":"R4-20260904","doi-asserted-by":"crossref","first-page":"1099","DOI":"10.1016\/S1474-4422(22)00400-8","article-title":"Safety and efficacy of continuous subcutaneous foslevodopa-foscarbidopa in patients with advanced Parkinson\u2019s disease: a randomised, double-blind, active-controlled, phase 3 trial.","volume":"21","author":"Soileau","year":"2022","journal-title":"Lancet Neurol"},{"key":"R5-20260904","doi-asserted-by":"crossref","first-page":"1695","DOI":"10.3233\/JPD-212813","article-title":"Foslevodopa\/foscarbidopa is well tolerated and maintains stable levodopa and carbidopa exposure following subcutaneous infusion.","volume":"11","author":"Rosebraugh","year":"2021","journal-title":"J Parkinsons Dis"},{"key":"R6-20260904","doi-asserted-by":"crossref","first-page":"107905","DOI":"10.1016\/j.parkreldis.2025.107905","article-title":"Continuous subcutaneous infusion therapies in Parkinson\u2019s disease: evidence of efficacy and safety.","volume":"139","author":"Katzenschlager","year":"2025","journal-title":"Parkinsonism Relat Disord"},{"key":"R8-20260904","doi-asserted-by":"crossref","first-page":"2705","DOI":"10.1111\/cns.14215","article-title":"Cardiac adverse events associated with quetiapine: disproportionality analysis of FDA adverse event reporting system.","volume":"29","author":"Shu","year":"2023","journal-title":"CNS Neurosci Ther"},{"key":"R9-20260904","doi-asserted-by":"crossref","first-page":"789","DOI":"10.2147\/CLEP.S365513","article-title":"A real-world disproportionality analysis of olaparib: data mining of the public version of FDA adverse event reporting system.","volume":"14","author":"Shu","year":"2022","journal-title":"Clin Epidemiol"},{"key":"R11-20260904","doi-asserted-by":"crossref","first-page":"427","DOI":"10.1002\/pds.1742","article-title":"Quantitative signal detection using spontaneous ADR reporting.","volume":"18","author":"Bate","year":"2009","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"R12-20260904","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1002\/pds.668","article-title":"A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions.","volume":"11","author":"van Puijenbroek","year":"2002","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"R13-20260904","doi-asserted-by":"crossref","first-page":"315","DOI":"10.1007\/s002280050466","article-title":"A bayesian neural network method for adverse drug reaction signal generation.","volume":"54","author":"Bate","year":"1998","journal-title":"Eur J Clin Pharmacol"},{"key":"R14-20260904","doi-asserted-by":"crossref","first-page":"396","DOI":"10.1002\/pds.4970","article-title":"Adverse drug reaction or innocent bystander? A systematic comparison of statistical discovery methods for spontaneous reporting systems.","volume":"29","author":"Dijkstra","year":"2020","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"R15-20260904","doi-asserted-by":"crossref","first-page":"123202","DOI":"10.1016\/j.jns.2024.123202","article-title":"Effect of concomitant use of esomeprazole on levodopa pharmacokinetics and clinical symptoms in patients with Parkinson\u2019s disease.","volume":"465","author":"Miyaue","year":"2024","journal-title":"J Neurol Sci"},{"key":"R16-20260904","doi-asserted-by":"crossref","first-page":"1454","DOI":"10.3390\/medicina59081454","article-title":"Pharmacological and Non-Pharmacological treatments for depression in Parkinson\u2019s disease: an updated review.","volume":"59","author":"Angelopoulou","year":"2023","journal-title":"Medicina (Kaunas)"},{"key":"R17-20260904","doi-asserted-by":"crossref","first-page":"581","DOI":"10.1111\/j.1464-410X.1988.tb04430.x","article-title":"Comparative study of the clinical usefulness of prostate specific antigen and prostatic acid phosphatase in prostatic disease.","volume":"62","author":"Buamah","year":"1988","journal-title":"Br J Urol"},{"key":"R18-20260904","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1186\/s13195-024-01669-4","article-title":"Post-marketing safety concerns with lecanemab: a pharmacovigilance study based on the FDA adverse event reporting system database.","volume":"17","author":"Xing","year":"2025","journal-title":"Alzheimers Res Ther"},{"key":"R19-20260904","doi-asserted-by":"crossref","first-page":"1599","DOI":"10.1080\/17425247.2025.2539962","article-title":"Navigating the therapeutic landscape in advanced Parkinson\u2019s disease: a comprehensive review from infusion therapies to stem cells.","volume":"22","author":"Fogliano","year":"2025","journal-title":"Expert Opin Drug Deliv"},{"key":"R20-20260904","doi-asserted-by":"crossref","first-page":"378","DOI":"10.1002\/mds.30069","article-title":"Skin inflammatory reactions in patients with continuous subcutaneous injection of foslevodopa-foscarbidopa hydrate: histopathology.","volume":"40","author":"Yoshihara","year":"2025","journal-title":"Mov Disord"},{"key":"R21-20260904","doi-asserted-by":"crossref","first-page":"2538","DOI":"10.1002\/mds.30297","article-title":"Subacute painful axonal polyneuropathy associated with foslevodopa\/foscarbidopa subcutaneous infusion in advanced Parkinson\u2019s disease.","volume":"40","author":"Valli","year":"2025","journal-title":"Mov Disord"},{"key":"R22-20260904","first-page":"412","article-title":"The treatment of older patients with Parkinson\u2019s disease.","volume":"122","author":"Djukic","year":"2025","journal-title":"Dtsch Arztebl Int"},{"key":"R23-20260904","doi-asserted-by":"crossref","first-page":"1937","DOI":"10.1007\/s40120-023-00533-1","article-title":"Continuous subcutaneous foslevodopa\/foscarbidopa in Parkinson\u2019s disease: safety and efficacy results from a 12-month, single-arm, open-label, phase 3 study.","volume":"12","author":"Aldred","year":"2023","journal-title":"Neurol Ther"},{"key":"R24-20260904","doi-asserted-by":"crossref","first-page":"389","DOI":"10.1002\/mds.30121","article-title":"Neutrophil-rich infusion site reactions after continuous subcutaneous application of foslevodopa\/foscarbidopa.","volume":"40","author":"Weise","year":"2025","journal-title":"Mov Disord"},{"key":"R25-20260904","doi-asserted-by":"crossref","first-page":"81","DOI":"10.1007\/s00198-022-06562-0","article-title":"Fracture risk in Parkinson\u2019s disease according to its severity and duration.","volume":"34","author":"Koo","year":"2023","journal-title":"Osteoporos Int"},{"key":"R26-20260904","doi-asserted-by":"crossref","first-page":"602","DOI":"10.1007\/s00774-022-01322-w","article-title":"Fracture risk and impact of osteoporosis in patients with Parkinson\u2019s disease: a nationwide database study.","volume":"40","author":"Kim","year":"2022","journal-title":"J Bone Miner Metab"},{"key":"R27-20260904","doi-asserted-by":"crossref","first-page":"104700","DOI":"10.1016\/j.nbd.2019.104700","article-title":"Autonomic dysfunction in Parkinson\u2019s disease: implications for pathophysiology, diagnosis, and treatment.","volume":"134","author":"Chen","year":"2020","journal-title":"Neurobiol Dis"},{"key":"R28-20260904","doi-asserted-by":"crossref","first-page":"1329","DOI":"10.3390\/jcm12041329","article-title":"Sex differences in motor and non-motor symptoms among spanish patients with Parkinson\u2019s disease.","volume":"12","author":"Santos-Garcia","year":"2023","journal-title":"J Clin Med"},{"key":"R29-20260904","doi-asserted-by":"crossref","first-page":"909936","DOI":"10.3389\/fmed.2022.909936","article-title":"Gender differences in levodopa pharmacokinetics in levodopa-naive patients with Parkinson\u2019s disease.","volume":"9","author":"Conti","year":"2022","journal-title":"Front Med (Lausanne)"},{"key":"R30-20260904","doi-asserted-by":"crossref","first-page":"1081","DOI":"10.1159\/000521214","article-title":"Polypharmacy and hyperpolypharmacy in older individuals with Parkinson\u2019s disease: a systematic review and meta-analysis.","volume":"68","author":"Bhagavathula","year":"2022","journal-title":"Gerontology"},{"key":"R31-20260904","doi-asserted-by":"crossref","first-page":"215","DOI":"10.3109\/03009747809095658","article-title":"Rheumatoid arthritis contributing to lumbar spinal stenosis. Neurogenic intermittent claudication.","volume":"7","author":"Magnaes","year":"1978","journal-title":"Scand J Rheumatol"}],"container-title":["Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.1097\/MD.0000000000048874","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T14:01:40Z","timestamp":1788530500000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.1097\/MD.0000000000048874"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,15]]},"references-count":29,"journal-issue":{"issue":"20","published-print":{"date-parts":[[2026]]}},"URL":"https:\/\/doi.org\/10.1097\/md.0000000000048874","relation":{},"ISSN":["0025-7974","1536-5964"],"issn-type":[{"value":"0025-7974","type":"print"},{"value":"1536-5964","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,15]]},"assertion":[{"value":"2025-12-23","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-29","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}}]}}