The final report is now in on the contaminated blood thinner heparin that caused as many as 81 deaths in the U.S.
A man-made chemical was added to batches of the drug, made in China, according to a report issued by the Centers for Disease Control and Prevention (CDC) and published in The New England Journal of Medicine (NEJM).
The contaminant has been identified as oversulfated chondroitin sulfate (OSCS) and is thought to be responsible for 152 adverse reactions as well as the deaths.
The heparin was distributed to at least 10 countries and 13 U.S. states and caused adverse reactions from November 2007 until January 2008.
The NEJM report describes the reactions as occurring within 30 minutes of administering heparin.
Patients experienced a drastic drop in blood pressure, nausea and shortness of breath, according to the Washington Post. Most of the reactions came from people during dialysis.
In January, the FDA issued its first recall of heparin made by Baxter Healthcare. A second recall followed in February. As recently as November 6, the FDA seized 11 lots of heparin from Celsus Labs in Cincinnati that were found to be contaminated, according to Medscape.
Chondroitin sulfate is made from animal cartilage while oversulfation comes from processing. OSCS is chemically similar to a dietary supplement used to treat joint pain.
Heparin’s raw ingredient is manufactured from pig intestines. In the case of the Chinese heparin, imported by Baxter Healthcare of Deerfield, Ill., supplies were derived from small unregulated companies.
The U.S. FDA admitted it hadn’t ever visited the Chinese manufacturing plant before the heparin scandal. The FDA is now opening three offices in China.
“There is a definite link between the contaminant and the patients who had these reactions,” said Dr. Priti R. Patel, an epidemiologist with the CDC.
New tests to screen for OSCS should be effective, researchers say. The report made no attempt to determine how and why the heparin was contaminated. But Reuters reports that co-author Ram Sasisekharian of MIT,says the contamination coincided with the spread of a virus in pigs in China that had created a shortage. #