乐鱼体育leyu-美国FDA警告！千万不要使用二手和未经批准的诊断试纸！

美国FDA正告！万万不要利用二手和未经核准的诊断试纸！2019-4-12 9:28:20 来历：RAPS 浏览数：

来历：RAPS

4月8日，美国食物药品监视治理局（FDA）正告患者不要利用二手或未核准上市的诊断试纸来监测血糖或华法林程度。

凡是，糖尿病患者天天需要利用血糖监测仪和试纸屡次测试血糖程度，以节制病情。服用血液稀释剂华法林的患者经由过程试纸丈量其国际尺度化比值（INR），该比值用在肯定华法林用药剂量。

“数百万美国人会在家里利用试纸来监测严重的疾病或病症。我们熟悉到，有些人可能会选择采办二手或未经核准的试纸，由于他们认为如许可以节俭本钱。但是，如许做可能会使他们处在严重受伤乃至灭亡的危险地步，”FDA器械和放射健康中间（CDRH）体外诊断和放射健康办公室主任Tim Stenzel说。

FDA暗示，他们已发现有人在Amazon、EBAY和Craigslist等网站上采办二手和未经核准的试纸，也有人直接从其他卖家处采办。

固然美国FDA暗示，今朝还没有收到与此类试纸相干的严重危险或灭亡陈述，但其正告说，试纸所显示的成果可能其实不正确，进而可能致使患者服药过量或服药过少。

FDA还暗示，二手试纸可能存在过时、贮存不妥或被上任利用者的血液污染等问题，这些身分都可能致使读数禁绝确或激发传染。

是以，FDA建议查抄包装是不是已打开或更改，并查抄其试纸包装上显示的有用期，并警戒任何注解试纸未经核准的唆使信息，如非英文申明。FDA正告说，不核实患者试纸处方的卖家可能出售的就是二手或未经核准的产物，由于假如用户可以或许在不��������leyu供给处方的环境下采办**处方的试纸，则注解其试纸在美国不被授权发卖。

FDA还要求患者向其MedWatch数据库上报利用试纸所酿成的危险或问题，并举报任何涉嫌在网上发卖的不法医疗产物。

对那些买不起试纸的患者，FDA鼓动勉励他们与大夫或配药师扳谈，看看是不是有任何患者支援打算或优惠券，帮忙他们下降本钱。

英文原文

FDA Warns Patients Against Using Pre-Owned and Unauthorized Diagnostic Test Strips

The US Food and Drug Administration (FDA) on Monday warned patients against using pre-owned or unauthorized diagnostic test strips used to monitor glucose or warfarin levels.

Patients with diabetes are typically required to test their blood sugar using a glucose monitor and test strips multiple times per day to manage their condition. For patients taking the blood thinner warfarin, test strips are used to measure their international normalized ratio (INR), which is used to determine dosing.

“Millions of Americans use test strips at home to monitor serios diseases or conditions. We recognize that some people may be choosing to purchase pre-owned or unauthorized test strips because they believe there is a cost savings. However, by doing so they may be putting themselves at risk for serious injury or even death,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health at the Center for Devices and Radiological Health (CDRH).

FDA says it has found preowned and unauthorized test strips for sale on online marketplaces including Amazon, EBAY and Craigslist, as well as directly from other sellers.

While the agency says it has not received reports of serious injuries or deaths associated with such test strips, it warns that inaccurate results could lead patients to take too much or too little medicine.

FDA says that pre-owned test strips could potentially be expired, improperly stored or contaminated with the previous owner’s blood, which could result in inaccurate readings or cause infection.

As such, FDA is advising patients to check the expiration dates on the packaging of their test strips and to be wary of signs that the test strips are unauthorized, such as instructions that are not in English. FDA warns that sellers who do not verify a patient’s prescr1ption for test strips may be selling pre-owned or unauthorized products.

FDA is also asking patients to report an injury or problem they have with test strips to its MedWatch database and to report any suspected unlawful medical products being sold online.

For patients who may be having difficulty affording their test strips, FDA encourages them to speak with their physician or pharmacist to see whether there are any patient assistance programs or coupons that could reduce their costs.