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DEERFIELD, Ill., January 15, 2009 — To reduce the risk of error regarding improper insulin dosing that occurs mostly in the hospital setting, Baxter International Inc. is collaborating with MedicAlert Foundation International to encourage patients on peritoneal dialysis using EXTRANEAL (icodextrin) Peritoneal Dialysis Solution to add a warning for potential for glucose monitor interference to their MedicAlert bracelet. MedicAlert provides critical medical information for its members to clinicians, payers and first responders 24-hours-a-day, anywhere in the world.
EXTRANEAL is a non-dextrose solution used in Peritoneal Dialysis (PD). Use of EXTRANEAL allows for enhanced ultrafiltration and optimized fluid balance in certain PD patients, which may lead to improved clinical outcomes. The corporation has been aware of an association of EXTRANEAL with falsely elevated blood glucose monitor readings when healthcare providers or patients test using non-specific glucose monitoring systems. Icodextrin, the active ingredient in EXTRANEAL, is metabolized to maltose, which is read as glucose by non-glucose specific glucose monitors. Falsely elevated glucose readings can lead to improper dosing of insulin and erroneous diagnosis of hyperglycemia and hypoglycemia, both of which are potentially life threatening. Baxter first began warning healthcare providers and patients in 1997 in Europe of improper glucose monitor usage in hospitals and addressed concerns through the 2002 FDA approval of EXTRANEAL in the United States. Baxter decided to work with MedicAlert because, despite an expansive communication and training effort, hospitals, healthcare providers and patients continue to use incompatible monitoring test strips and devices.
“It is important that we continue to work with hospitals, healthcare workers and patients to raise greater awareness about using the appropriate glucose monitor with patients on EXTRANEAL,” says Sarah Prichard, MD, vice president of global clinical affairs for Baxter’s Renal business. “This advanced dialysis solution is critical in many patients’ peritoneal dialysis home therapy, and we all need to ensure glucose monitoring is occurring accurately. We believe that this alert mechanism will help create an important link between the patient and the care giver. These patients and their regular providers in dialysis units have a good understanding of the need to use glucose-specific monitors, but healthcare workers in other settings, most importantly in hospitals, may not be as familiar with peritoneal dialysis, EXTRANEAL and the interaction with non-specific glucose monitors.”
Accordingly, Baxter has worked with MedicAlert to add the warning about the EXTRANEAL-glucose monitoring system interference to the MedicAlert database. The warning can also be added directly to the patient’s MedicAlert bracelet and will help alert hospital staff about the need to use glucose-specific monitors and test strips with the patient. In the event that a patient requires medical attention and is not responsive, a MedicAlert bracelet communicates critical information about the patient. Baxter is now strongly recommending patients using EXTRANEAL wear a MedicAlert bracelet or necklace that communicates the potential for glucose monitoring system interference.
Because approximately 50 percent of peritoneal dialysis patients are diabetic, MedicAlert can provide a benefit not only for the potential for glucose monitor interference but also for the patient’s diabetic condition.
“MedicAlert has been working for more than 50 years now with diabetic patients and we applaud Baxter’s willingness to make certain that both patients and providers are alert to all the glucose monitor issues related to patients on EXTRANEAL. Partnerships between MedicAlert and companies like Baxter lead the way in promoting patient safety in a time when innovative life-saving drugs and treatments are becoming increasingly available,” said N.Visveshwara M.D, medical affairs advisor to MedicAlert Foundation.
Over the years, Baxter has implemented a number of measures to alert patients and healthcare providers to differences between glucose monitoring systems and the need to use glucose-specific monitors and test strips with patients on EXTRANEAL (icodextrin) PD Solution. Baxter has implemented numerous mitigations in recent years, which includes the distribution of an enhanced patient communication toolkit to patients when EXTRANEAL is added to their prescription. The toolkit includes:
Baxter reminds physicians, providers and patients to only use glucose-specific monitors and test strips, common in clinical laboratories. “Glucose-specific” applies to monitors and test strips that can distinguish between glucose and other sugars (e.g., maltose). More information, including recommended monitors and test strips, indications, and the full prescribing guidelines for EXTRANEAL (icodextrin) PD Solution, can be found at www.glucosesafety.com.
About MedicAlert
MedicAlert Foundation International pioneered the first medical identification service in 1956 as a way to provide people with a simple but effective method for communicating their medical conditions. Since the organization’s founding, MedicAlert has provided services and products that protect and save lives of its four million members. For more than 50 years, the organization has relayed vital medical information on behalf of its members to emergency responders so they receive faster and safer treatment. MedicAlert bracelets or pendants alert emergency personnel to a member’s primary health conditions. In addition to its 24-hour emergency response service, MedicAlert provides family notification so that members can be reunited with their families. More information is available at www.medicalert.org.
About Baxter
Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
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