Heparin Ingredients collected from unregulated farms, FDA claims

April 30, 2008

New York, NY - Heparin is an injectable blood-thinning drug that is mainly given to dialysis patients (about 450,000 in the US alone). It is also administered in heart surgery and occasionally given to patients with blood-clotting problems due to its ability to prevent the formation of clots that can lead to stroke or heart attacks.

Heparin Allergic Reactions in U.S. and Canada

Up until February, 2008 Baxter Healthcare Corporation controlled about half of the heparin supply for the US, which totaled about 100,000 vials a day. After receiving hundreds of reports (including some from 2007) that patients experienced allergic reactions to the drug, Baxter recalled nine lots of its multi-dose heparin, but continued to make single-dose vials. Baxter's rationale was that, if all of its heparin was recalled, it would create a market shortage thereby creating more risk to patients relying on the drug—even though other companies produced the drug.

In the beginning of February, the Federal Drug and Administration Agency (FDA) linked four deaths to heparin but by the end of the month, the death toll rose to 28. Baxter halted production of all its product.

Another heparin company is Braun Medical Inc., a supplier of heparin in Canada. On March 21, in conjunction with Health Canada, the FDA announced that Braun recalled 23 lots (each lot contained 25,000 units) of its tainted heparin products that were distributed to the US, Canada and Australia.

Heparin Ingredients Obtained from Unregulated Farms in China

The FDA has since discovered that heparin companies had its raw ingredient—pig intestines—often collected from small, mostly unregulated farms in China. It has been found that the contaminant, an altered form of chondroitin sulfate, could mimic heparin and was therefore used as a cheaper substitute. Chondroitin sulfate is sold as an over-the-counter dietary supplement. Tainted batches of heparin's active ingredient were produced at a plant in Changzou, China, which is operated by Scientific Protein Laboratories—suppliers to Baxter, Braun and Covidien (below).

FDA officials finally announced that it found evidence linking the contaminant to allergic reactions that had now resulted in at least 81 deaths. SPL concurred that the contaminant was added before crude heparin material reached Baxter's supplier in China and that the contamination appeared deliberate.

Heparin Recalled

On April 2, the health-care company Covidien, formerly Tyco Healthcare, recalled 32 lots of its product after SPL identified a heparin-like contaminant in the syringes. A lawsuit was filed against Covidien in federal district court in Boston, alleging that the company had supplied tainted doses of heparin to a man who died as a result of allergic reactions to the drug. The lawsuit further claims that the company waited weeks to recall the tainted heparin after other suppliers had conducted their own product recalls.

Symptoms of allergic reactions to heparin included anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.

The FDA has said that all heparin now supplied to the US has been tested for the contaminant and is safe. However, the FDA is under fire for not acting sooner—allegedly, it could have prevented countless wrongful deaths.

Contact a Phildelphia Personal Injury Lawyer

When you need a lawyer who will exhaustively investigate your heparin case and make sure that every responsible party is held accountable, contact The Killino Firm, where Keeping America Safe is our primary goal. Contact a Phildadelphia personal injury attorney, or please call us toll free at 800-815-2603 to speak to one of our attorneys. We will respond promptly to your inquiry so that you can experience The Killino Firm Difference.

Reporting personal injury law news.