ST LOUIS (MD Consult) - On July 1, 2009, the US Food and Drug Administration (FDA) issued an early communication concerning the safety of Lantus (insulin glargine). The decision to publish this alert was made after the FDA became aware of 4 recently published observational studies that investigated the use of Lantus and the possible risk for cancer in patients with diabetes. Results from 3 of these studies suggest that an increased risk for cancer exists with the use of Lantus.

 

In all the referenced observational studies, information derived from large patient databases showed some level of association between the use of insulin glargine—and other insulin products—and various types of cancer. However, limitations to the studies deserve some consideration, according to the FDA. The duration of patient follow-up in all the studies was shorter than what is generally considered necessary to evaluate for cancer risk from drug exposure. Furthermore, inconsistencies in findings within and across individual studies raise concerns as to whether an association between the use of insulin glargine and cancer truly exists. Additionally, differences in patient characteristics across the treatment groups may have contributed to a finding of increased cancer risk.

 

The FDA is currently reviewing many sources of safety data for Lantus, including that from these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials. Discussions are also ongoing between the FDA and the manufacturer of Lantus as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed.

 

The FDA communication states that the posting of this information does not mean that the agency has concluded that a causal relationship exists between the drug product and the emerging safety issue, nor does it mean that the FDA is advising physicians to discontinue prescribing this product. The agency has not yet reached a conclusion about whether this information warrants any regulatory action.

 

Similar to human insulin, insulin glargine is used to control blood glucose in persons with type 1 and type 2 diabetes. Insulin glargine is an insulin analogue that allows for the control of blood glucose over an extended period of time, and the drug is approved for once-daily dosing by subcutaneous injection.

 

Health care professionals and consumers are encouraged to report adverse events occurring with the use of insulin glargine to the FDA's MedWatch Adverse Event Reporting Program online, by telephone (1-800-FDA-1088), or by sending the postage-paid FDA form 3500 by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or by fax to 1-800-FDA-0178.

圣路易斯(MD Consult)——2009年7月1日，美国食品药品管理局(FDA)发布应用Lantus(甘精胰岛素)的安全性警示。在探讨糖尿病患者应用Lantus与潜在癌症风险的关系方面，近期共发表4项观察性研究，其中3项研究的结果表明，应用Lantus可使癌症发生风险增加。获知此信息后，FDA作出了发布该警示的决定。

在所提到的各项观察性研究中，大型患者数据库的分析结果均表明，应用甘精胰岛素——以及其他胰岛素产品——与多种类型的癌症之间存在某种程度的相关性。然而FDA认为，鉴于研究中存在某些局限性，分析结果有待斟酌。相对于常规认为的评价药物致癌风险所必需的随访时程而言，上述各项研究中的患者随访时程较短。此外，各项研究间及各项研究内部的结果亦不一致，这使人们对应用甘精胰岛素与癌症之间是否确实存着相关性产生顾虑。另外，不同试验组之间的患者特点存在差异，可能与癌症风险增加这一结果有关。

FDA目前着眼于对多个Lantus安全性资料的来源进行审查，其中包括这些新近发表的观察研究数据，所有完成的对照临床试验数据，以及进行之中的对照临床试验资料等。同时，FDA也在与Lantus生产商讨论是否需要做进一步的研究，对该药的安全性和有效性做出评价。

FDA的这条警示表明，发布此信息并非意味着当局已断定应用该药与出现安全隐患之间存在因果关系，亦非意味着FDA在推荐医生停用该药品。至于此信息是否支持做任何相关的调整，FDA尚未得出定论。

甘精胰岛素与人胰岛素相近，用于控制1型和2型糖尿病患者的血糖水平。作为一种胰岛素类似物，该药品能够在较长时间内控制血糖水平，现已获准1日1次皮下注射给药。

鼓励卫生专业人士和用药者对使用甘精胰岛素时发生的不良事件在线报告至FDA MedWatch不良事件报告系统，亦可致电(1-800-FDA-1088)报告，或者将邮资已付的FDA 3500表格邮寄至MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787，或发传真至1-800-FDA-0178。