Providers Asked to Report Adverse Heparin Reactions
Health care providers have been asked to report adverse patient reactions to injectable heparin, heparin lock flush solutions, or any medical products that contain or are coated with heparin to the Food and Drug Administration (FDA).
Contaminated injectable heparin and heparin flushes were recalled in early 2008. FDA scientists identified a contaminant—an oversulfated chondroitin sulfate—that mimics heparin activity so closely that it was not recognized by routine testing. The contaminated heparin has caused allergic reactions and hypotension, resulting in 131 deaths.
Providers should report:
- Events with signs or symptoms consistent with allergic reactions, acute hypotension, or acute gastrointestinal distress
- Other serious reactions that may be attributed to the heparin such as unexplained thrombocytopenia; excessive anticoagulation or hemorrhage; inadequate anticoagulation; unexplained or premature thrombosis of a heparin-coated device; and invalid results of in-vitro diagnostic tests that use heparin as part of the assay or specimen collection.
Providers can report an event by going online to the FDA’s MedWatch program website; downloading a PDF form and mailing it to 5600 Fishers Lane, Rockville, MD 20852-9787 or faxing it to (800) FDA-0178; or calling (800) 332-1088.
Visit the FDA website for more information, including a list of medical devices containing heparin; information on the adverse events; and information on recalls.
Last Updated: 8/1/2008