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

Posted 08 April 2019 | By Michael Mezher 

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 prescription 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.
 
FDA, Safety Communication, Consumer Update

Categories: Regulatory News

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