Contaminated Heparin Found in 11 Countries

The New York Times has reported on a story since April 10th, 2008 that Heparin is suspected as a factor in as many as 62 possible deaths occurring since December 2007.

The FDA has posted information on its websites, containing a chart of reported heparin deaths.

The NY Times published another story today on the front page which states that contaminated heparin has been discovered in 11 countries. Since most of the contaminated heparin was originally manufactured in China, the discovery of contamination cases outside the US indicates that the problems in production were probably not direct result of any US manufacturing process. According to the NY Times article, 12 different Chinese companies supplied contaminated heparin to 11 different countries.

Since the recall, US supplies have been verified to be safe.

Dr. Janet Woodcock, director of the FDA's drug center, mentioned in the NY Times article that the US heparin supply had been fully tested with the most sensitive testing assays and has been found free of contaminants. Patients should speak with their doctors to ensure that any administered Heparin is safe and has been purchased since the recall.

Chinese Suppliers and Baxter Healthcare Recall

Baxter Healthcare Corporation seems to be primarily involved in the distribution of the affected dosages. The NY Times reports that Baxter purchased heparin ingredients from the Chinese company, Scientific Protein Laboratories (Changzhou SPL). According to the FDA, Baxter Healthcare has initiated a voluntary recall of all vials of heparin sodium used for injection including heparin lock flush solutions. Baxter Healthcare's Heparin Recall Information Page.

According to a press release issued by Baxter (in pdf form), Baxter has confirmed that some "adulterated" heparin contained over-sulfated chondrointin sulfate as a contaminant. Their tests show NO adverse reactions with unadulterated heparin. Baxter said that while they have established a causal link between the contaminated samples of heparin and decreased blood pressure and increased clotting; they say that there are many factors that influence a patient's response to the contaminated heparin dosages. In the press release Norbert Riedel, Ph.D, VP and Chief Scientific Officer at Baxter Corporate said,

"A reaction to contaminated heparin could also depend on the patient's particular physiology, underling medical conditions, such as heart disease, different medications being administered to the patient, or the dose and volume of heparin they received."

Baxter disputes the FDA claim that heparin products have been linked to 81 deaths. The pharmaceutical company insists it has only identified 5 deaths in which the company supplied drugs which could have contributed to the deaths.

What is Heparin?

Heparin is a drug giving as an anticoagulant. Typically known as "blood thinners," drugs such as Heparin are used to prevent clotting in the bloodstream after surgery. The body naturally produces Heparin in basophils and mast cells. Heparin was discovered in 1916, and is one of the oldest drugs still in clinical usage.

• Wikipedia article on Heparin
• Other FDA information on Heparin Recall:
• FDA Heparin Advisory
  
• FDA Heparin Public Health Update
  

Healthcare Providers can report suspected Heparin or other drug allergies to the FDA's MedWatch, by fax at 1-800-FDA-0178, by mail, or by telephone at 1-800-FDA-1088.