美国食品和药物管理局警告,与Ocaliva使用相关的PBC患者的严重肝损伤,敦促密切监测. FDA warns of severe liver injuries linked to Ocaliva use in PBC patients, urging close monitoring.

美国食品和药物管理局强调,对于没有肝硬化的初级胆道胆炎 (PBC) 患者,Ocaliva (奥贝蒂霍尔酸) 有严重的肝损伤风险. The FDA has highlighted serious liver injury risks associated with Ocaliva (obeticholic acid) for patients with primary biliary cholangitis (PBC) without cirrhosis. 后期市场数据显示,与安慰剂相比,肝脏严重受伤(包括肝移植和死亡)的风险更高。 Postmarket data shows a higher risk of severe liver injury, including liver transplants and deaths, compared to placebo. 林业发展局正在敦促密切监测肝功能,并建议如果有肝病发展或缺乏功效的迹象,停止使用该药物。 The FDA is urging close monitoring of liver function and has advised discontinuing the drug if there are signs of liver disease progression or lack of efficacy. 在发出这一警告之前,曾对肝硬化晚期病人使用奥卡利瓦的情况实行限制。 This warning follows previous restrictions on Ocaliva use in patients with advanced cirrhosis.