| アブストラクト | BACKGROUND: Lanthanum carbonate is widely used to manage serum phosphate and calcium levels in end-stage kidney disease (ESKD) patients, yet comprehensive long-term safety data are lacking. This study leverages the FDA Adverse Event Reporting System (FAERS) to assess the extended safety profile of lanthanum carbonate. RESEARCH DESIGN AND METHODS: We analyzed FAERS data (2004-2022) to study the association between lanthanum carbonate and adverse events (AEs). Using MedDRA v25.0, we identified risk signals through System Organ Classes (SOCs) and Preferred Terms (PTs). Disproportionality analyzes quantified lanthanum carbonate-associated AE signals. RESULTS: Among 3,284 reports, 2,466 were primary suspected AEs linked to lanthanum carbonate. Males reported AEs more frequently than females. Patients aged over 64 represented the majority. Median onset time for lanthanum carbonate-related AEs was 146 days. Gastrointestinal disorders were prevalent. We identified 16 new signals, including stress, abnormal hepatic function, cholelithiasis, bile duct stone, gastric cancer, and adenocarcinoma gastric. Stress was notable, particularly in male patients over 65 and those with lower weight. CONCLUSIONS: This study affirms lanthanum carbonate's long-term safety for reducing elevated blood phosphorus levels. While gastrointestinal disorders were common, attention must focus on emerging AEs, particularly stress, especially in elderly patients. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2024/4/11 |
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| 投稿者 | Ying, Mengjia; Shi, Jian; Ling, Yahao; Shi, Tao; Liao, Lele; Cao, Linhui |
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| 組織名 | Department of Pharmacy, People's Hospital of Longhua, Shenzhen, Guangdong, China.;Department of Cardiology, The Eighth Affiliated Hospital, Sun Yat-sen University,;Shenzhen, Guangdong, China.;Department of Traditional Chinese Medicine, Sun Yat-sen Memorial Hospital, Sun;Yat-sen University, Guangzhou, Guangdong, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38602862/ |
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