Baxter International issued a heparin recall in February 2008 after the drug was linked to reports of severe and potentially fatal allergic reactions. The Food and Drug Administration has received reports of at least 785 cases of serious injuries and at least 19 deaths which may have been caused by heparin allergic reactions.
Heparin is a blood thinning drug which is manufactured from an enzyme found in pig intestines. The drug can be given to patients before some surgeries, such as a heart bypass, or to kidney patients. Baxter manufactures about half of the heparin which is used in the United States.
Beginning in January 2008, the FDA and the Centers for Disease Control and Prevention began receiving reports of severe allergic reactions in patients who were given heparin. These reactions included breathing problems, increased heart rate, nausea, vomiting and a rapid drop in blood pressure that could lead to fatal shock.
After these cases of heparin allergies were linked to nine lots of the drug manufactured by Baxter, the company issued a heparin recall to remove them from the market. However, when the FDA learned of addition cases of allergic reactions that were not linked to these lots, Baxter was forced to halt production and to issue a complete heparin recall.
The FDA is currently investigating reports that the allergic reaction outbreak may be connected with the Chinese plant where Baxter’s heparin is produced. Studies have shown that as much as 20% of the heparin in these vials is actually an unknown contaminant which closely resembles the drug. Researchers are trying to determine whether the contaminant was deliberately mixed with the drug to increase production, or whether contamination occurred accidentally.
If you were given heparin during surgery or kidney dialysis and have suffered a severe heparin allergic reaction, contact the law office of Sam Levine to ensure that your legal rights are protected. You can reach us by calling toll-free at (888) 404-LAWYER, or by filling out our online contact form.
