The Food and Drug Administration announced on February 28 that “potential deficiencies” at a Chinese plant that produces the active ingredient in Heparin, a blood thinner used to treat blood clots during dialysis and after some surgery, is a possible cause of 21 deaths, as well as hundreds of allergic reactions including vomiting, nausea and difficulty breathing. Baxter International, the company which makes the brand of Heparin that is now considered a potentially dangerous product, has announced an immediate recall of virtually all of its Heparin products, which it buys from a Chinese plant known as Changzhou SPL.
Heparin is made from pig intestines. In China and other developing countries, tracing the source of the animals used to make the product can be very difficult. The FDA also acknowledged that other problems which could have led to the manufacture of the dangerous product include the lack of specific procedures outlining removal of impurities, and no records showing the suppliers’ source of the products.
The Food and Drug Administration estimates that over one million multi-dose vials of Heparin are sold per month in the United States, and half of those are manufactured and distributed by Baxter. However, the FDA has provided assurances that there is an adequate supply in the market to meet the demand for Heparin, which clearly is a necessary and lifesaving drug.