Heparin is an anticoagulant used to avoid blood clotting during coronary artery bypass graft surgery and dialysis; it has been linked to several deaths and caused hundreds of dangerous side effects in patients.
Heparin is injected in order to block the formation of fibrin, which is responsible for the formation of blood clots. It can also be used to treat abnormal blood clots found in blood cells. Heparin may be administered by an injection, through intravenous tubes or through a subcutaneous injection (given under the skin). The dosage depends on the kind of clot to be prevented.
More than half of the Heparin used in the U.S. is manufactured by Baxter International; most of these are distributed by B. Braun Medical Inc. Baxter announced a recall of several lots of 1000/unit mL Heparin vials after the company began receiving complaints of allergic reactions in patients who had been given Heparin injections. By February, the Food and Drug Administration reported that 4 deaths had occurred as a result of Heparin use. In addition, the FDA reported that there had been approximately 350 allergic reactions in patients who had been given injections.
These reactions included:
- Respiratory difficulties
- A sharp fall in blood pressure
After the first recall, the number of reactions reported increased, these incidents involved Heparin lots that had not been included in the first recall. By the end of February, the number of deaths caused by Heparin injections had risen to a total of 21 and the company announced that it was temporarily halting the manufacturing of Heparin products. In March of 2008, B. Braun Medical Inc. also began recalling Heparin products that were distributed to the U.S, Canada and Australia.
Source of Tainted Heparin
Since then, the FDA has confirmed that the batches of Heparin responsible for the allergic reactions and deaths were contaminated. It has isolated the source of the contamination, concluding it originated in China where the main ingredient used in heparin is manufactured. The contamination resulted from the processing of chondroitin sulfate. This chemical is made from animal products and is widely used as a dietary supplement and as a treatment for arthritic joint pain. When Chondroitin Sulfate is processed, the over sulfated chemical compound that results is very similar to Heparin in the kind of blood thinning properties it has.
The FDA has not confirmed if the processed Chondroitin Sulfate was added to the drug on purpose because it is cheaper to produce than the original raw ingredient in Heparin, or if it was added by accident, but one thing is certain – the addition of doctored chondroitin sulfate was not a natural part of the manufacturing process. Since the tainted Heparin was traced to a Scientific Protein Laboratories plant (SPL) in Changzhou, China, it has been revealed that the FDA had not conduct inspections of the plant since it was approved in 2004.