FDA Alert

The Food and Drug Administration (FDA) is asking the assistance of nurses and other healthcare providers to end the continued use of contaminated heparin products, and to report adverse events which may be heparin-related. 
 
Since mid-January, several manufacturers and distributors have recalled injectable heparin products and heparin flush solutions, including Baxter International, Inc., Covidien, B. Braun Medical Inc., and AHP/American Health Packaging.  Specific recall information is available here.

Unfortunately, affected products have been found in medical facilities in one state, since the recall announcements. 
 
The FDA has identified one contaminant, oversulfated chondroitin sulfate, or OSCS, not recognized in initial testing.  OSCS can activate the kinin-kallikrein pathway in human plasma, generating bradykinin (a potent vasoactive mediator) and C3a and C5a (potent anaphylatoxins), leading to anaphylaxis.  From January 2007 to mid-April 2008, the FDA received reports of 131 deaths associated with heparin administration, due to allergic or hypotensive symptoms. 
 
The FDA is asking all health professionals and facilities to 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, the FDA wants to inform health professionals about other types of medical devices which may contain, or be coated with, heparin.  These can include intravascular catheters, oxygenators, pumps, filters, and blood reservoirs used during cardiac procedures, vascular stents/grafts, and blood collection tubes.  This list is updated frequently, and can be found here.
 
Nurses and other healthcare providers should report any adverse events related to the use of heparin products - or devices that may contain heparin -- to the FDA's MedWatch program or 1-800-332-1088.   Voluntary Report Form FDA 3500 can be obtained at www.fda.gov/medwatch/getforms.htm.  If your facility participates in FDA's Medical Product Safety Network (MedSun) program, reports should be submitted to the MedSun website.  Include detailed information about the product in question, the patient, and the nature of the adverse event.  (See:   http://www.fda.gov/cdrh/safety/heparin-healthcare-update.html.)
 
For more information, please contact the FDA's Division of Drug Information, at 301/796-3400.