What Does Heparin Do?

Heparin is an anticoagulant (blood thinner) that is used to prevent and treat blood clots in the veins, arteries and lungs. The drug is commonly used before certain types of surgery, including coronary artery bypass graft surgery, and in kidney patients before they undergo dialysis.

If you or a family member became ill because of tainted heparin, please call Skikos Crawford Skikos & Joseph for a free consultation.

FDA Finds Contamination in Certain Heparin Lots

In January 2008, the FDA announced it had learned about an increase in the number of serious allergic-type reactions associated with certain types of intravenous doses of heparin for injection manufactured by Baxter Healthcare Corporation. Patients infected included patients with kidney failure on hemodialysis, patients undergoing photopheresis and plasmapheresis and some patients who have had blood clots in arteries and veins. These findings led to a limited recall of the product on January 17, 2008.

The FDA later identified a previously unknown contaminant in heparin's active ingredient that was manufactured in China. The active ingredient in heparin is made from the internal lining of pig intestines, and can be made under very unsanitary conditions in China. The contaminant was identified by the FDA as oversulfated chondroitin sulfate (OSCS), a substance that mimics the biological activity of heparin. Chondroitin sulfate is a popular dietary supplement derived from shellfish that is often used by arthritis sufferers.

The FDA inspected Baxter's Chinese heparin supplier, and found serious deficiencies at the facility. The incident has sparked a great deal of debate concerning the oversight of Chinese facilities that produce ingredients for pharmaceutical drugs consumed in the United States.

As of June 2008, the FDA did not know how the contaminant got into the product. However, since the contaminant is not naturally occurring it likely was used intentionally in order to reduce the manufacturing cost of the product.

Contaminated Heparin Lots Have Caused Serious Injuries

Serious injuries have been reported as a result of the contaminated heparin, including:

• Low blood pressure
• Abdominal symptoms
• Shortness of breath
• Excessive sweating
• Rapidly falling blood pressure
• Life-threatening shock

Reactions to the contaminated drug generally occur rapidly after use of the drug. By March 2008, the FDA has stated it received 785 reports of serious injuries and 19 deaths associated with the tainted drug. The long term effects of the contaminant are still being investigated by the FDA.

Contact Us If You Suffered Serious Injuries From Contaminated Heparin

If you or someone you know has suffered serious shock or injury as a result of use of contaminated Heparin, please contact us or give us a call at Skikos Crawford Skikos & Joseph for a free consultation.