Heparin Contaminant found in 11 Countries!

China is continuing to deny their part in the contamination of the Heparin supply and the related deaths. They have even gone so far as to imply that the contamination could have occurred in a US plant. There is no denying on their part now, as the countries affected have climbed to 11 including: Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States.

With this latest revelation, China has at least accepted responsibility for the contaminant (oversulfated condroitin sulfate, or OSCS), but denies this resulted in the over 800 adverse reactions and the 81 deaths the FDA has attributed to it in the U.S. alone. FDA has conducted testing which has linked the OSCS to the adverse reactions observed. Additionally, The FDA has traced the lots in question to 12 Chinese companies involved in the heparin’s manufacturing.

Worldwide, the heparin recalls have expanded to include recalls from numerous companies that use heparin in a variety of medicinal products: Baxter (heparin); B.Braun (heparin solutions); Covidien (pre-filled syringes); American Health Packaging (heparin sodium vials); Hospira (heparin syringes, vials, and bags); AstraZeneca (heparinized saline); Sanofi-Aventis (Clexane drug); Rotexmedica (heparin products); Opocrin (heparin API); Sierra Pre-Filled Inc.(heparin lock and normal saline flushes); G. Bichsel AG (heparin products); and Arseus NV -Fagron (heparin).

The FDA has updated their testing to include two screening tests and is currently working with US Pharmacopeia, a non-profit organization dedicated to safety in the pharmaceutical industry on further testing.

Clearly, the magnitude of these recalls echo the need for more encompassing and rapid screening tests in the pharmaceutical arena. As the saga continues, manufacturers and suppliers should ask the question – Am I doing everything possible to ensure my supply is secure?

As the number of deaths stemming from the Heparin tragedy increases, so must our vigilance to make sure this does not happen again.