FDA Issues New Warning About Warfarin Test Strips

The FDA is warning patients and doctors that certain test strips used to monitor levels of the blood thinner warfarin may provide inaccurate results and should not be relied upon to adjust the drug dosage.¹

Medical product distributor Terrific Care/Medex Supply LLC issued a voluntary recall of certain Roche Diagnostics test strip lots used with CoaguChek test meter devices last month. Today, the FDA classified this action as a Class I recall, the most serious type of recall, indicating that the use of these devices may cause serious injuries or death.¹

Patients and health care providers who are using CoaguChek meters should immediately stop using test strips purchased from Terrific Care/Medex Supply and use an alternative test method.¹

According to the FDA, all lot numbers of these test strips sold by Terrific Care LLC. or Medex Supply with manufacturing dates of October 2017 to May 2018, and distributed December 27, 2017 to December 15, 2018, are involved in the recall.² These test strips are used with the CoaguChek XS Plus, CoaguChek XS Pro, CoaguChek XS Professional, CoaguChek XS PST, and CoaguChek Vantus test meter devices.¹

This recall is related to the November 2018 recall of test strips manufactured by Roche Diagnostics, which is still in effect. The recall conducted by Roche involved more than 1.1 million packages of CoaguChek XS PT Test Strips that were distributed nationwide from January 12, 2018 to October 29, 2018. The CoaguChek XS PT Test Strips announced in today’s recall were manufactured by Roche, but distributed by Terrific Care/Medex Supply and include catalog numbers that were not included in the Roche recall.¹

These strips were not labeled or authorized for sale in the United States and were only distributed by Roche Diagnostics outside the country. Terrific Care/Medex Supply purchased the Roche test strips from an unknown source, imported these products, and sold them in the United States.¹

“Monitoring warfarin dosing is a critical part of using the drug properly to prevent and treat blood clots. Using faulty strips can lead to errors in medication dosage that could cause serious harm or death in some patients. That’s why it’s so concerning that this distributor continued to sell these test strips in the US even though domestic sales had been stopped due to safety concerns. To reduce risks to patients, we’re warning health care providers and the public about the dangers associated with this product,” said FDA Commissioner Scott Gottlieb, MD, in a prepared statement.¹ “Distributing products that are not labeled or authorized for sale in the United States raises significant concerns for us in view of the serious safety issues with these test strip devices, and our work on this matter is not finished. Our top priority is the immediate safety of patients, and we’re taking steps to ensure the products that this company distributed are removed from the market.”

As with the previous recall, the FDA is warning patients and health care professionals that they should not rely on these test meter devices to monitor warfarin levels if they’re using test strips affected by the recall. Instead, they should have blood drawn from a vein and have their levels measured by a laboratory test or use an alternative meter device.¹

Achieving the correct warfarin dosage is crucial, and patients need regular monitoring to test how long it takes their blood to clot. The response is measured by a blood test to check the International Normalized Ratio, or INR. This test can be performed by an accredited laboratory on blood drawn from a vein or with a fingerstick blood draw using an INR test meter at home or in a doctor’s office.¹

The FDA’s previous warning concerning the CoaguChek XS PT Test Strips was based on medical device reports submitted by Roche Diagnostics to the agency indicating that the test strips may provide results that are higher than the actual INR. As a result of incorrect INR results, some patients may be prescribed an insufficient warfarin dose or instructed to interrupt warfarin use, which may increase the risk for dangerous blood clots.¹

Incorrect INR results are of particular concern for individuals at an increased risk of blood clots including those with mechanical heart valves, with atrial fibrillation (irregular heartbeat) who are at a high risk of stroke, or those who had a recent blood clot. It is important to note that problems with the CoaguChek XS PT test strips are not likely to be evident to the patient.¹

References

• FDA warns patients and doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S. [news release]. Silver Spring, MD; February 1, 2019. FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630408.htm. Accessed February 1, 2019.
• Medical Devices—Terrific Care, LLC. / Medex Supply Recalls CoaguChek XS PT Test Strips Used to Monitor Blood Thinner Warfarin Due to Inaccurate Test Results. FDA website. http://www.pharmacytimes.com/link/253. Updated February 1, 2019. Accessed February 1, 2019.