Baxter Heparin Allergic Reaction

There have been over 750 reported cases of Baxter’s Heparin causing serious side effects, including severe allergic reactions. The allergic reactions range from:

drops in blood pressure
nausea and vomiting
increased heart rate
swelling around the mouth
difficulty breathing
sweating

Scientists determined, after exhaustive testing, that the contaminated Heparin supplied from the Chinese facility to Baxter International caused the allergic reactions. The tests do not definitively link the allergic reaction to the contaminated Heparin; however, a strong causal connection exists.

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The allergic reactions were reported by users of Baxter’s Heparin Sodium Injection multi-dose vials. The multi-dose vials are used for patients that require a large dose of Heparin over a short time. The patients that reported allergic reactions are those with: kidney failure, certain types of heart surgeries, and blood clots in their arteries or veins. The severe allergic reactions generally occur within minutes of the Baxter Heparin dosage, although there have been cases where there is a major drop in blood pressure an hour later. There have been no instances where the allergic reaction has occurred well after the injection of Baxter Heparin or where Baxter Heparin has been administered in small doses.

Tests Determine the Cause of Heparin’s Allergic Reactions

An independent test performed by the FDA and Baxter International concluded that the allergic reactions were caused by a contaminant [oversulfated chondroitin sulfate (OSCS)] in the Baxter Heparin. OSCS is used to treat arthritis patients. The chemical makeup of OSCS is very similar to the make up of Baxter Heparin, allowing the switch to remain undetected by Baxter’s routine tests. The contaminant that caused the allergic reactions can be traced back to Scientific Protein Laboratories, the Baxter Heparin supplier that produces Heparin in Changzhou, China.

Allergic Reactions from Contaminated Heparin Reported in Germany

There have been over 100 reports of severe allergic reactions by Heparin users in Germany. An investigation performed by German authorities determined that the allergic reactions were from Heparin manufactured by a German company, Rotexmedica, which receives its Heparin supply from a Chinese facility. The Rotexmedica supplier is not the same as the Chinese facility that supplies Heparin to Baxter. This shows that the Heparin contamination problem may be widespread and include multiple protein supplier in China. China is the largest Heparin producer in the world, which suggests a significant problem.