Overview of the Heparin Recall and the Contaminant

On or about January 17, 2008, Baxter issued a press release regarding the voluntary recall of nine lots of Heparin Sodium Injection multiple-dose vials in 1000 units/mL concentrations of 10mL and 30mL vials, 5000 units/mL concentration of 10mL vials, and 10,000 units/mL for 4mL vials. (See “Baxter Urgent Product Recall.”) See also FDA 1/25/08 Press Release: “Baxter Issues Urgent Nationwide Voluntary Recall of Hepain 1,000 Units/ml 10 and 30ml Multi-Dose Vials.”) This voluntary recall was the result of an abnormal increase in the reports of potentially fatal adverse patient reactions associated with the use of heparin. These adverse patient reactions as identified by the FDA include the following: 

allergic or hypersensitivity-type reactions, with symptoms of oral swelling, abdominal pain, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia [painful, difficult, or disturbed digestion], dyspnea [unpleasant or uncomfortable breathing], erythema [redness of the skin], flushing, headache, hyperhidrosis [excessive sweating], hypoesthesia [reduced sense of touch or sensation], increased lacrimation [production, secretion, and shedding of tears], loss of consciousness, malaise [general discomfort or uneasiness], nausea, pallor, palpitations, paresthesia [tingling, pricking, or numbness of a person's skin], pharyngeal edema [swelling in throat], restlessness, vomiting/retching, shortness of breath, stomach discomfort, sweating, tachycardia [rapid beating of the heart], thirst, trismus [Inability to open the mouth fully], unresponsiveness to stimuli, and/or severe hypotension [abnormally low blood pressure]. 

[Explanations added by Zoll, Kranz & Borgess, LLC.]

The initial recall identified the following heparin products: 

• Heparin 1000 units/mL, 10 mL vial, expiration date 10/2009, Lot #107054

• Heparin 1000 units/mL, 10 mL vial, expiration date 11/2009, Lot #117085

• Heparin 1000 units/mL, 30 mL vial, expiration date 10/2008, Lot #047056

• Heparin 1000 units/mL, 30 mL vial, expiration date 9/2009, Lot #097081

• Heparin 1000 units/mL, 30 mL vial, expiration date 10/2009, Lot #107024

• Heparin 1000 units/mL, 30 mL vial, expiration date 10/2009, Lot #107064

• Heparin 1000 units/mL, 30 mL vial, expiration date 10/2009, Lot #107066

• Heparin 1000 units/mL, 30 mL vial, expiration date 10/2009, Lot #107074

• Heparin 1000 units/mL, 30 mL vial, expiration date 10/2009, Lot #107111

On February 11, 2008, Baxter temporarily stopped manufacturing multiple-dose vials of injectable heparin due to the potentially life-threatening adverse and allergic reactions and incidents of hypotension that were reported. (See FDA 2/11/08 Press Release: “Baxter’s Multiple-dose Vial Heparin Linked to Severe Allergic Reactions.”) 

In light of continuing reports of comparable adverse events associated with the use of multiple-dose heparin vials not within the initial recall, Baxter and the FDA issued additional press releases recalling all remaining lots and doses of its multiple-dose vials, single dose vials, and HEP-LOCK heparin flush products on February 28, 2008. (See FDA 2/28/08 Press Release: “Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products.”  See also Baxter 2/28/08 News Release.)

On March 19, 2008, the FDA announced that it had identified the contaminant as over-sulfated chondroitin sulfate. (See FDA Media Briefing on Heparin. ) Over-sulfated chondroitin sulfate is a chemical compound and is not an approved drug in the United States. Chondroitin, which most often comes from animal cartilage, must be chemically modified to create over-sulfated chondroitin sulfate. When so treated, chondroitin appears to be heparin when subjected to standard tests. The FDA reports there is no known intravenous use for this chemical compound. The link between this contaminant and the reported adverse reactions was confirmed in an article published online by the New England Journal of Medicine on April 23, 2008, entitled, “Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System.” 

On April 15, 2008, Andrew von Eschenbach, the head of the U.S. Food and Drug Administration, stated at a Senate Hearing that the contamination of the heparin was, ``we suspect, done by virtue of economic fraud.” (See Transcript of 4/15/08 Senate Appropriations Subcommittee Hearing.) 

According to the FDA, as of April 21, 2008, there have been 131 reports of death in patients receiving heparin since January 1, 2007, with 123 of said deaths reported to the FDA on or after January 1, 2008. (See FDA 4/21/08 Updated “Information on Adverse Event Reports and Heparin.”) Out of the 131 reported deaths, 81 of the reports of death included one or more allergic symptom(s) or symptoms of hypotension, with 78 of said deaths reported to the FDA on or after January 1, 2008.


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