Alere INRatio Withdrawal Announced
July 11, 2016 – Alere, Inc. announced that it is withdrawing all of its INRatio® and INRatio®2 PT/INR monitoring systems from the U.S. market. INR (international normalized ratio) and PT (prothrombin time) measure how long blood takes to clot. In December 2014, Alere advised that some systems under reported INR by up to 12.2 INR units when compared to plasma INR testing done by a laboratory. Alere has since been working with the U.S. FDA to make changes that prevent the errors. However, no solution has been found and Alere has decided to discontinue the devices. Target INR values for patients taking anticoagulant medications are between 2.0 and 3.0 INR units. Values above 4.5 units increase the risk of excessive bleeding. Readings for patients with several conditions, including anemia, cancer, end-stage kidney disease, acute or chronic infections and inflammatory disorders, were particularly likely to be incorrect. Nine serious adverse events related to using the systems prompted the initial recall.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.