Early Communication Issued Regarding Atrial Fibrillation With Oral and Intravenous Bisphosphonates

　　2007年10月2日美国FDA在马里兰的BETHESDA公布了正在进行的关于房颤与二磷酸盐关系的安全性的汇总资料。二磷酸盐主要用于治疗增加骨质疏松患者的骨密度，降低发生骨折的危险；减慢乳腺癌患者的骨转换，治疗骨转移，降低癌症患者升高的血钙水平。

　　FDA回顾其上市后口服或静脉应用二磷酸盐与房颤关系的报道，并未发现应用二磷酸盐的患者增加发生房颤的危险。

　　此外该回顾性分析还包括仅仅上市一年用于治疗绝经后妇女骨质疏松的Reclast（唑来磷酸）的资料，FDA评估了房颤与Reclast可能的关系。多数房颤病例发生于应用药物1个月后。而且，在应用药物后监测心电图11天的患者亚组分析中，房颤的发生率在应用Reclast和安慰剂的患者见没有明显差异。

　　鉴于目前的研究，严重房颤的资料如何解释仍然不清楚。因此，目前FDA认为医生和患者仍可继续应用二磷酸盐。

　　（摘译自 www.docguide.com）

Early Communication Issued Regarding Atrial Fibrillation With Oral and Intravenous Bisphosphonates

BETHESDA, MD -- October 2, 1007 -- U.S. Food and Drug Administration issued an early communication about the ongoing review of new safety data regarding the association of atrial fibrillation with the use of bisphosphonates.

Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, treat bone metastases, and lower elevated levels of blood calcium in patients with cancer.

FDA reviewed spontaneous postmarketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation.

In addition, as part of the data review for the recent approval of once-yearly Reclast (zoledronic acid) for the treatment of postmenopausal osteoporosis, FDA evaluated the possible association between atrial fibrillation and the use of Reclast. Most cases of atrial fibrillation occurred more than 1 month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo.

Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time.