Yesterday morning, the Food and Drug Administration warned against using home-use test strips – including those for glucose and warfarin – that have been used from a previous owner or products not authorized for sale in the U.S. The agency says they could lead to infection, false test results and serious illness and death for some.
“Millions of Americans use test strips at home to monitor serious 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,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
Test strips for use at home are common and help patients with blood sugar imbalances, for example, manage their condition and determine if they are maintaining good levels of blood glucose. It’s not uncommon for people to find these non-authorized strips through online merchants such as eBay, Amazon, or direct from a seller’s website.
FDA said it does not have any record of death or serious outcomes from people using the strips but feels a warning is needed as the potential for harm is real if, for example, the products have expired or been improperly stored. Such circumstances could lead to false results and poor treatment decisions (e.g., taking too little or too much medication). Infection is also a concern if people are purchasing pre-owned strips inadvertently contaminated with tiny amounts of the previous owner’s blood.
The FDA recommends:
· inspecting the package to check whether it has been opened or altered and to check expiration dates
· noting that if you can purchase prescription-only test strips without a prescription then they may not be unauthorized for sale in the U.S.
· purchasing only from a trusted source, such as a local pharmacy or through the test strip manufacturer
