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Important Medical Alerts

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  • May 9, 2008
    Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS). Affected heparin products have been found in medical care facilities in one state since the recall announcement. Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used. There have been many reports of deaths associated with allergic or hypotensive symptoms after heparin administration (see FDA link at http://www.fda.gov/cder/drug/infopage/heparin/adverse_events.htm). We ask that health professionals and facilities please review and examine all drug/device storage areas, including emergency kits, dialysis units and automated drug storage cabinets to ensure that all of the recalled heparin products have been removed and are no longer available for patient use. In addition, FDA would like to inform health professionals about other types of medical devices that contain, or are coated with, heparin. To read this update, and to learn how to report these problems to FDA, please go to: http://www.fda.gov/cdrh/safety/heparin-healthcare-update.html. Please report to FDA adverse reactions associated with these devices, as well as any reactions associated with heparin or heparin flush solutions. If you have questions or would like more information about this request, please contact the Division of Drug Information at 301-796-3400.
  • March 12, 2008
    Amgen and FDA Announce Changes to Erythropoiesis Stimulating Agents Boxed Warnings
    Information now describes the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs (Aranesp and EPOGEN/PROCRIT).
  • January 18, 2008
    AM2 PAT, Inc. Issues Nationwide Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flushes
    Full details can be found on the FDA Web site.
  • January 17, 2008
    Baxter Announces Recall of Heparin
    Full details, including the specific lots recalled, can be found on the FDA Web site. Get the free Acrobat Reader
  • July 20, 2007
    Update to March 12, 2007, posting: Medicare to Modify its Claims Monitoring Policy for Use of ESAs for Anemia Treatment in Dialysis
    The Centers for Medicare & Medicaid Services (CMS) has announced that it is strengthening its erythropoiesis stimulating agent (ESA) Monitoring Policy (EMP) for claims for ESAs used to treat anemia in Medicare beneficiaries who are receiving dialysis treatment for end stage renal disease (ESRD).
  • March 12, 2007
    FDA Revises Recommendations Regarding ESAs
    The U.S. Food and Drug Administration (FDA) has revised the labeling information for Erythropoiesis Stimulating Agents (ESAs) and issued revised recommendations for dosing and monitoring patients using ESAs. Full details can be found on the FDA Web site. The Renal Physicians Association (RPA), the National Kidney Foundation (NKF), the American Association of Kidney Patients (AAKP), and the Centers for Medicare and Medicaid Services (CMS) have responded publicly to the FDA's recommendations. Patients who are concerned about their use of ESAs should consult their own health care team.
  • December 22, 2006
    Contrast Agents Containing Gadolinium and Nephrogenic Fibrosing Dermopathy
    The FDA has posted a Public Health Advisory concerning the relationship between certain contrast agents used during Magnetic Resonance Imaging (MRI) scans and the development of Nephrogenic Fiborsing Dermopathy in kidney disease patients.
  • October 31, 2006
    Immunization Guidlines
    The National Immunization Program at CDC has assembled all the recommendations for vaccinating patients with chronic kidney disease into one document, Guidelines for Vaccinating Kidney Dialysis Patients and Patients with Chronic Kidney Disease. The guidelines can be found on our Immunization Coalition page.
  • October 23, 2006
    Counterfeit Blood Glucose Test Strips
    The FDA has alerted the public to counterfeit blood glucose test strips being sold in the United States for use with various models of LifeScan, Inc., One Touch® Brand Blood Glucose Monitors. Details can be found on the FDA Web site.
  • May 19, 2006
    Spectrum Laboratory Products Tacrolimus Active Pharmaceutical Ingredient [API] Recalled
    Full details, including a link to Spectrum's announcement of the recall, can be found on the FDA Web site.
  • December 22, 2005
    Pandemic Flu Information
    Network 11 would like to keep you and your facility informed regarding a potential Pandemic Flu. All states have been required by the Centers for Medicare and Medicaid Services (CMS) to develop state-wide Pandemic Flu Plans. The Network 11 Pandemic Flu page contains links to each state's Pandemic Flu Plan and a variety of other resources.