On January 25, 2008, Baxter Healthcare Corporation announced the voluntary recall of nine lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials.
The company began recalling the lots on January 17, 2008 as a precautionary measure due to an increase in the number of reports of adverse patient reactions that may be associated with the product. These adverse patient reactions included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, feeling your heart beat strong or fast, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst and difficulty opening the mouth. Baxter noted that some of these reactions may be severe or life threatening.
To see more specifics on the Baxter Recall of Heparin you may visit www.baxter.com or click here: Baxter Issues Urgent Nationwide Voluntary Recall of Heparin. See also FDA 1/25/08 Press Release: “Baxter Issues Recall of Heparin Multi Dose Vials.” At http://www.fda.gov/oc/po/firmrecalls/baxter01_08.html or click here: FDA Baxter Heparin Recall Notice.
On February 11, 2008, Baxter temporarily stopped the manufacture of multiple-dose vials of injectable heparin due to the potentially life-threatening adverse and allergic reactions and incidents of hypotension low blood pressure that were being reported. Other serious reactions to the drug included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that could lead to life-threatening shock. Four people died after receiving heparin, although the relationship to the drug was not clear. For more from the FDA go to http://www.fda.gov/bbs/topics/NEWS/2008/NEW01797.html or click here: FDA Baxter Press Release 2-11-08.
On February 28, 2008, Baxter announced that the company was proceeding with the voluntary recall of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products due to continuing adverse event reports. The company reported that nearly all reported adverse reactions have occurred in three specific areas of product use – renal dialysis, invasive cardiovascular procedures and aphaeresis procedures. For more information about the recall go to http://www.baxter.com/about_baxter/news_room/news_releases/2008/2-28-08-heparin.html or click here for the: Baxter Press Release; or click here for the: FDA Press Release.
On March 19, 2008, the FDA announced in a Media Briefing See FDA Media Briefing that the contaminant in the Heparin was an over-sulfated chondroitin sulfate. The FDA explained that over-sulfated chondroitin sulfate is not ordinarily found in nature and that it is a chemical compound that is not an approved drug in the United States. The over-sulfated chondroitin sulfate was discovered when FDA scientists conducted tests on the Heparin product and this was confirmed in a New England Journal of Medicine Article. See Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System NEJM June 2008. Ultimately, the contaminant was tracked back to a plant in China that supplied Baxter with its Heparin API. When the FDA inspected the plant in China, the agency concluded there were so many problems with the facility that the FDA blocked the plant from exporting to the United States. Baxter had been purchasing Heparin ingredients from the Changzhou SPL plant from 2004 through 2008, but had never inspected the facility until September 2007.
As of April 21, 2008, the FDA stated there had been 131 reports of death in patients receiving heparin since January 1, 2007. See FDA Information on Adverse Event Reports and Heparin. For additional information on the Heparin recall and a situation overview please visit the FDA Website or the Baxter Website. See also Heparin Situation Overview – May 21, 2008.
The law firm of Blizzard, McCarthy & Nabers is accepting cases from individuals or family members who have suffered injury or death as a result of the Heparin contamination. If you or a loved one has experienced any injury or damage due to the use of Heparin, please do not hesitate to contact our office by using the form below or dialing (866) 879-3040.
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