GMP,药品,药学,制药,新药,色谱,药品生产,中药,药材,原料药,医药,中间体,药用辅料

英国药监局关于雷尼酸锶的相关信息

时间: 2008-09-18 02:47:07 作者: 来源: 字号:
16 November 2007
雷尼酸锶为一种用于治疗绝经后妇女骨质疏松症的非激素类治疗药物。
在其使用过程中已有严重不良反应出现。这些反作用已经包括皮疹伴有嗜酸细胞增多全身的症状(DRESS)。DRESS是一类严重的具有生命危险的药物过敏反应。它出现皮疹,继而发热,水肿,血液中白细胞增多,影响肝脏,肾脏和肺功能。停止治疗同时,应用皮质甾醇类疗法((减少免疫系统活动)通常可以改善症状,但是恢复缓慢,且有复发可能。欧洲代理机构已发表声明,在处方及患者信息中加入这一风险提示是非常紧迫的。
对规定者和病人的忠告:
妇女服用,如出现皮疹应警惕严重过敏反应的发生。应立即停药并快速就医。被迫停止服用就不能再继续服用。
该信息具有真实性吗??
本人一直在关注该品种,能否发原文来看看啊
没问题,我也是在关注这个品种过程中发现的
16 November 2007

Strontium ranelate (brand name Protelos▼ in the UK and Osseor in some other European countries) is a non-hormonal medicine used in the treatment of postmenopausal osteoporosis in women.

Concerns have arisen about the risk of severe allergic reactions in association with its use. These reactions have included drug rash with eosinophilia systemic symptoms (DRESS). DRESS is a serious and life-threatening type of allergic reaction to some medicines. It starts with a skin rash, accompanied by a fever, swollen glands, increased numbers of white cells in the blood and can effect the liver, kidneys and lung. Stopping treatment together with corticosteroid therapy (medicines that reduce the activity of the immune system) usually results in the symptoms improving, but recovery can be slow and there is a risk of symptoms returning during the recovery period.

The European Medicines Agency has issued a statement advising that the prescribing and patient information for Protelos▼ is being updated as an urgent measure to include warnings about this risk.

Advice to prescribers and patients
Women taking Protelos▼ should be alert to the risk of severe allergic reactions and if they develop a rash, they should stop taking the medicine and consult their doctor immediately. Once Protelos▼ treatment has been stopped it should not be re-introduced.

原文地址:http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON2033058
发表评论 共有条评论
验证码: 看不清楚,点击刷新 匿名发表