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Heparin Identification and Adverse Effects

Colorado, Wyoming, Ohio, and Nationwide

Adulterated Heparin

March 19, 2008: FDA Director of Drug Evaluation and Research, Dr. Janet Woodcock, announces at an FDA Media Briefing on Heparin that FDA has identified the contaminant in Baxter’s Heparin products. The contaminant is oversulfated chondroitin sulfate (OSCS). While chondroitin sulfate is a naturally occurring compound, (commonly available and widely used as a dietary supplement for treatment of osteoarthritis), OSCS does not occur naturally. Instead, FDA considers OSCS to be the result of chemical modification to ordinary chondroitin sulfate.

OSCS mimics Heparin’s activities. Therefore, it was not detected in initial screening tests performed on contaminated Heparin. Dr. Woodcock emphasizes that OSCS is not an approved drug for sale in the United States, and it is not permitted to be found in Heparin.

April 15, 2008: Dr. Andrew von Eschenbach, Commissioner of the FDA, states in Senate testimony regarding Heparin contamination, “we suspect, [it was] done by virtue of economic fraud ....” In other words, the FDA’s working assumption is that the contaminant was intentionally introduced during the manufacturing process in order to increase Heparin supplies or profits.

April 23, 2008: Two major medical articles on contaminated Heparin are released. The first article, “Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events,” 2008 Nature Biotechnology, describes the process used to identify OSCS in Heparin samples associated with adverse events. The second article, “Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System,” 2008 NEJM, replicated in vitro the chemical response that triggers the induction of anaphylatoxins in humans, and replicated in pigs the hypotensive response seen in humans to OSCS.

Adulterated Heparin Adverse Effects

Initially thought to be allergic reactions to Heparin, doctors finally realized that Heparin contained a contaminant, oversulfated chondroitin sulfate, which triggered serious and even deadly adverse reactions among patients exposed to this illegal and unnatural compound.

Adverse reactions include:

  • Abnormal sensation of the lips, mouth, or skin
  • Burning sensation
  • Chest pain and rapid heart rate
  • Decreased blood pressure
  • Decrease sensitivity of the skin
  • Diarrhea
  • Dizziness and fainting
  • Flushing and sweating
  • Shortness of breath
  • Stomach pain, nausea, and vomiting
  • Swelling throat and difficulty opening the mouth
  • Watery Eyes
  • Unresponsiveness

Many deaths have been reported from contaminated Heparin. Anaphylactic shock, even if not fatal, can cause severe and permanent damage to vital organs, such as the kidneys. The FDA reports 81 deaths among persons known to have been exposed to contaminated Heparin. This

If you or a loved one has suffered adverse reactions to contaminated Heparin, please contact the experienced Heparin lawyers at Burg Simpson Eldredge Hersh and Jardine, P.C.