双氯芬酸钠凝胶的肝脏损害警告

收藏分享 2009-12-14 18:41| 发布者: tianniao| 查看数: 86| 评论数: 0

【发布时间：2009年12月4日】Endo制药公司、诺华公司和FDA联合告知医护人员已对1%双氯芬酸钠局部用凝胶（diclofenac sodium topical gel）的处方信息中涉及肝脏影响的部分进行了修订，以增加新的有关在接受所有含双氯芬酸钠的药品治疗期间肝功能检验值可能升高的警告和注意事项。

在上市后报告中，已有在接受双氯芬酸治疗期间的最初一个月内的任意时间发生药源性肝中毒事件。在上市后监督中已报告的严重肝脏不良反应事件包括肝坏死、黄疸、伴有或不伴有黄疸的暴发性肝炎、肝衰竭。这些已报告的事件中部分已导致死亡或肝移植。

医生应对接受双氯芬酸长期治疗的患者定期检测转氨酶。进行首次和随后转氨酶检测的最佳时间尚不明确。根据临床试验数据和上市后体验，在开始双氯芬酸治疗后的4~8周内应监测转氨酶。(丁香)

Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes
Audience: Rheumatological healthcare professionals, pharmacists

[Posted 12/04/2009] Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the prescribing information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac.

source:www.fda.gov

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