On February 29, 2008, Baxter International, Heparin’s manufacturer, recalled all Heparin products after it received reports that linked Heparin to more than 400 life-threatening allergic reactions, including 21 deaths. The allergic reactions were reported by users of Baxter’s Heparin Sodium Injection multi-dose vials. The patients affected are those with kidney failure or undergoing certain heart surgeries because these patients require a large dose of Heparin over a short time.
Baxter and the FDA both conducted studies to determine the source of the allergic reactions. They concluded that the allergic reactions were caused by a contaminant in the Heparin of oversulfated chondroitin sulfate (OSCS), a supplement used to relieve arthritis. The chemical make-up of OSCS is similar to Heparin’s make-up, allowing the switch to remain undetected by Baxter’s routine tests. Scientific Protein Laboratories (SPL), Baxter’s Heparin supplier, provided Baxter with the contaminated Heparin. SPL received the contaminated Heparin from their facility in Changzhou, China.
The FDA recommends that doctors limit Heparin use and dosage and only administer it if there are no medical alternatives. The FDA is currently working with APP Pharmaceuticals, another FDA approved Heparin manufacturer, to insure that there is a safe and adequate Heparin supply for the United States.
Heparin overdose is the most publicized cause of Heparin deaths. In November 2007, actor Dennis Quaid’s twin infants and another infant in Cedars-Sinai Medical Center in Los Angeles, CA received a dosage of heparin that was 1,000 times stronger than the appropriate dosage. In June 2008, hospital officials at the Christus Spohn Hospital South in Corpus Christi, Texas began investigating the death of a newborn who received a Heparin overdose. As part of that investigation, the hospital announced that fourteen infants were mistakenly administrated a Heparin overdose at the hospital. Infant Heparin overdoses occurred often because Baxter produced both adult dosage vials and child dosage vials in extremely similar bottles, which caused hospital staff to mistakenly administer the wrong dosage. Baxter recently changed the color and font of the adult Heparin vial to reduce human error when administrating Heparin.
Heparin is an intravenous drug that thins the blood to prevent clotting. Heparin is most commonly used during heart surgery, dialysis, and to avoid blood clots in bedridden patients. Baxter International manufactures about half the supply of Heparin and 75% of large multi-dose vials. Heparin is the most popular blood thinner medication because it works quickly and swiftly leaves the system.
If you or a loved one suffered or may have suffered an allergic reaction or overdose related to Heparin, please contact one of our Heparin lawyers for a free and confidential case evaluation. You may be entitled to compensation for your injuries.
