{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T23:26:08Z","timestamp":1789687568180,"version":"4.0.1"},"reference-count":11,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"unspecified","delay-in-days":92,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Open Heart"],"accepted":{"date-parts":[[2025,9,6]]},"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Sotatercept, an activin signalling inhibitor approved in March 2024 for pulmonary arterial hypertension (PAH), demonstrated efficacy in clinical trials. This pharmacovigilance study evaluated its real-world safety profile using the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to identify postmarketing risks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>FAERS reports from 2024 were analysed, focusing on cases where sotatercept was designated as the primary suspect. Duplicate entries were removed using standardised FDA protocols. Adverse events (AEs) were categorised using the Medical Dictionary for Regulatory Activities (MedDRA V.28.0). Disproportionality signals were assessed via reporting ORs (RORs; 95% CI lower limit &gt;1 with \u22653 cases). Severity was classified using the EudraVigilance Important Medical Events (IMEs) list.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 1\u2009484\u2009350 deduplicated reports, 613 sotatercept-associated AEs (1717 occurrences, 395 MedDRA terms) were identified. Disproportionality analysis revealed 48 safety signals: 30 aligned with labelled risks (eg, haemoglobin elevation (ROR=272.2), telangiectasia (ROR=334.1)) and 18 novel signals. The most frequent AEs included headache (n=78), epistaxis (n=57) and diarrhoea (n=53). Two unlabelled events\u2014cerebral haemorrhage and ascites\u2014met criteria for critical IMEs. Most reports originated from the USA (98.5%) and involved females (73.6%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study confirms sotatercept\u2019s labelled risks (haematological and vascular effects) and identifies novel safety concerns, including cerebral haemorrhage and ascites, highlighting the need for vigilant monitoring in PAH management. Real-world data underscore the value of postmarketing surveillance for detecting rare or unanticipated AEs. Clinicians should prioritise monitoring for haematological abnormalities and bleeding risks. Longitudinal studies are warranted to clarify long-term safety outcomes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/openhrt-2025-003636","type":"journal-article","created":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T06:15:36Z","timestamp":1759299336000},"page":"e003636","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Postmarketing analysis of sotatercept: identifying serious unlabelled events"],"prefix":"10.1136","volume":"12","author":[{"given":"Zhiyu","family":"Cao","sequence":"first","affiliation":[{"name":"The First Clinical Medical School, Guangzhou Medical University, Guangzhou, Guangdong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qifang","family":"Xiao","sequence":"additional","affiliation":[{"name":"School of Health Management, Guangzhou Medical University, Guangzhou, Guangdong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuemei","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, Guangzhou Medical University, Guangzhou, Guangdong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huan","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, Guangzhou Medical University, Guangzhou, Guangdong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4983-4343","authenticated-orcid":false,"given":"Mei","family":"Zhang","sequence":"additional","affiliation":[{"name":"Guangzhou Medical University, Guangzhou, Guangdong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,9,30]]},"reference":[{"key":"2026010701112773000_12.2.e003636.1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2024277"},{"key":"2026010701112773000_12.2.e003636.2","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa2213558"},{"key":"2026010701112773000_12.2.e003636.3","doi-asserted-by":"crossref","DOI":"10.1183\/13993003.01347-2022","article-title":"Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension","volume":"61","author":"Humbert","year":"2023","journal-title":"Eur Respir J"},{"key":"2026010701112773000_12.2.e003636.4","doi-asserted-by":"crossref","DOI":"10.1183\/13993003.01107-2023","article-title":"Effects of sotatercept on haemodynamics and right heart function: analysis of the STELLAR trial","volume":"62","author":"Souza","year":"2023","journal-title":"Eur Respir J"},{"key":"2026010701112773000_12.2.e003636.5","first-page":"857","article-title":"Sotatercept: First Approval","volume":"84","author":"Kang","year":"2024","journal-title":"Drugs (Abingdon Engl)"},{"key":"2026010701112773000_12.2.e003636.6","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2415160"},{"key":"2026010701112773000_12.2.e003636.7","doi-asserted-by":"crossref","first-page":"111509","DOI":"10.1016\/j.jclinane.2024.111509","article-title":"A pharmacovigilance study of FDA adverse events for sugammadex","volume":"97","author":"Mao","year":"2024","journal-title":"J Clin Anesth"},{"key":"2026010701112773000_12.2.e003636.8","doi-asserted-by":"crossref","first-page":"1486","DOI":"10.1016\/j.bja.2024.10.013","article-title":"Glucagon-like peptide-1 receptor agonists and impaired gastric emptying: a pharmacovigilance analysis of the US Food and Drug Administration adverse event reporting system","volume":"134","author":"Huang","year":"2025","journal-title":"Br J Anaesth"},{"key":"2026010701112773000_12.2.e003636.9","doi-asserted-by":"crossref","DOI":"10.1183\/13993003.01424-2024","article-title":"Efficacy and safety of the activin signalling inhibitor, sotatercept, in a pooled analysis of PULSAR and STELLAR studies","volume":"65","author":"Hoeper","year":"2025","journal-title":"Eur Respir J"},{"key":"2026010701112773000_12.2.e003636.10","doi-asserted-by":"crossref","first-page":"102385","DOI":"10.1016\/j.jchf.2024.12.005","article-title":"Global Burden of Pulmonary Arterial Hypertension and Associated Heart Failure: Global Burden of Disease 2021 Analysis","volume":"2025","author":"Huang","year":"2025","journal-title":"JACC Heart Fail"},{"key":"2026010701112773000_12.2.e003636.11","doi-asserted-by":"crossref","first-page":"105","DOI":"10.1038\/s41569-024-01064-4","article-title":"Mechanisms and treatment of pulmonary arterial hypertension","volume":"22","author":"Ghofrani","year":"2025","journal-title":"Nat Rev Cardiol"}],"container-title":["Open Heart"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/openhrt-2025-003636","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,7]],"date-time":"2026-01-07T09:11:37Z","timestamp":1767777097000},"score":1,"resource":{"primary":{"URL":"https:\/\/openheart.bmj.com\/lookup\/doi\/10.1136\/openhrt-2025-003636"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7]]},"references-count":11,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2025,9,30]]},"published-print":{"date-parts":[[2025,7]]}},"alternative-id":["10.1136\/openhrt-2025-003636"],"URL":"https:\/\/doi.org\/10.1136\/openhrt-2025-003636","relation":{},"ISSN":["2053-3624"],"issn-type":[{"value":"2053-3624","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,7]]}}}