Heparin Recall
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Heparin Contaminated
Heparin is a drug that has been on the market since 1935 for use as an anticoagulant. It is widely used in heart surgery, in kidney dialysis and in other surgical procedures to minimize clotting. Heparin is also used as a coating on a number of medical devices employed during surgery. It is used to coat stents – the devices inserted in arteries during some angioplasties in order to keep the artery open. For most uses, heparin is delivered as an intravenous injection.
On February 11th of 2008 the FDA issued a public advisory about "serious adverse events" associated with heparin injections using products supplied by the Baxter Healthcare Corporation. Baxter recalled certain of their heparin products in response; later in February Baxter expanded its recall to additional products. The FDA at that time had confirmed 81 deaths in this country associated with the use of heparin.
Today, that number has grown to over one hundred. Deaths have been reported in Germany and the heparin recall has expanded to at least ten other countries. Baxter has traced the contamination source of their heparin products to a Chinese manufacturing facility that produced the heparin used in their products.
The heparin recall has continued to take some unusual twists. The FDA has suggested that some of the companies manufacturing medical devices coated with heparin may want to begin utilizing a new testing procedure. At least one, Medtronic, has recalled some of its surgical devices as a result. The extent of the contamination remains unknown; what is known is that Baxter produces half the heparin used in the U.S.
In April an MIT team of researchers identified the potential source of heparin contamination as a molecular change in the proscribed manufacturing technique. Apparently this change allows substantial cost savings to the manufacturer, and also is not picked up in the standard screening techniques that, until recently, were used to check heparin being put into products for sale to the medical market.
On May 10th the FDA put out an appeal to medical practitioners and facilities to once again check to make sure that all recalled heparin products had been pulled off the shelves. Monitoring in California showed several medical facilities still holding stocks of the contaminated heparin, along with at least one pharmacy. Meanwhile, the Congress is pushing the FDA to disclose the Chinese manufacturer(s) of the recalled heparin, which the FDA has thus far refused to do.
