Thousands of Americans depend on the popular blood thinner Heparin to help them survive, but over the past few weeks the drug has been linked to 21 deaths and hundreds of adverse reactions likely due to contamination during the manufacturing process. Nearly half of all of the raw ingredients used to make Heparin are produced in China. The main active ingredient, which is derived from pig intestines, is thought to be likely culprit of the contamination and in turn the adverse events associated with the medication.
Until last week, leading manufacturer Changzhou Scientific Protein Laboratories had no operating license and had been completely unregulated, either by Chinese authorities or the Food and Drug Administration, a violation the FDA’s own inspection policy.
The FDA inspection discovered that the factory was used material from what they called an “unacceptable vendor” and had not taken the adequate steps to “identify impurities and deficiencies” associated with manufacturing equipment.
Baxter International, a major manufacturer, has halted sales of the product and issued a voluntary nationwide recall of all lots of Heparin. The investigation to find the source of the problem is still ongoing.
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