Tainted Doses of Heparin Linked to Death

Heparin, an anticoagulant primarily used during major surgical procedures and dialysis, has been linked to violent allergic reactions, leading to life-threatening shock and death.  Baxter Healthcare, the maker of the drug, was at one point forced to halt the manufacture of heparin sodium and recall existing lots after reports of deaths and hundreds of reactions linked to the drug. 

In early 2008, the U.S. Food and Drug Administration found that the deaths and injuries caused by heparin were due to a tainted supply of the medication manufactured in China for Baxter Healthcare.  Over one million multiple-dose vials of heparin are sold per month in the United States; half of the vials are manufactured by Baxter. The FDA did not find contamination with other heparin manufacturers.

Heparin is given intravenously or subcutaneously, primarily used after a heart attack, during hemodialysis treatment, or after other major surgical procedures, to thin blood and avoid the development of deep vein thrombosis, also known as blood clots.  Most of the reactions occurred in patients at hemodialysis centers, almost exclusively involving patients receiving a bolus dose – which is a high dose administered over a short time.  
In April 2010, the FDA issued a safety alert indicating that heparin, made under the new United States Pharmacopeia (USP) Monograph ("new heparin") has approximately 10 percent less blood-thinning activity compared to heparin prepared using the previous ("old") USP Monograph. The FDA first alerted the public to changes in the potency of heparin in a Public Health Alert in October 2009.
The communication states that a 10 percent decrease in heparin activity is not likely to have clinical significance, but physicians should carefully monitor certain situations, such as cardiac surgery or use in pediatric patients to achieve optimal therapeutic response. The FDA suggests that dosage adjustments and more frequent monitoring may be needed where aggressive anticoagulation is essential to the treatment of the patient.  The labeling for heparin, including the recommended doses, has not changed.
The FDA cautions that both old and new heparin may be available for some time, and the agency suggests that pharmacies and hospitals separate the supplies of old and new heparin, not using the products interchangeably, and exhausting the supplies of "old" heparin before transitioning to the "new" product.  

You should talk to your healthcare professional about any concerns you may have with heparin.  You can also report any serious adverse events associated with the use of this drug directly to the FDA on MedWatch.

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