Federal regulators have urged makers of many kinds of medical devices that contain Heparin, a contaminated blood thinner, to test their supplies. The products to be tested cover a wide spectrum of equipment and uses. They include kits that flush out intravenous lines, drug-coated stents for opening clogged arteries, and certain diagnostic tests that use heparin and could deliver inaccurate results if contaminated. The FDA has received two reports of serious allergic reactions linked to medical devices that contained heparin. The reactions to the blood thinner are similar to those seen in some patients who received intravenous heparin that was recalled this year. The FDA has sent letters to 82 medical device manufacturers urging them to test their heparin for contamination.

The FDA also released statistics on deaths linked to intravenous heparin, the form of the drug in which problems were first detected. The numbers showed an increase in fatalities from November 2007 through February 2008. At last count, 81 deaths were associated with the use of heparin. As you may recall, Baxter Healthcare Corp. issued a recall for the product. The particular side effect that investigators are focusing on is a severe allergic reaction that can lead to a sudden and highly dangerous drop in blood pressure. The statistics showed that the number of reported deaths jumped from two in October to eight in November, and reached a peak of 16 in January. It was the sudden increase in such reports that was said to have prompted Baxter to alert the FDA to the problem. The FDA’s statistics showed 62 deaths associated with the severe reaction in the 15 months from January 2007 through last month — an increase from the agency’s previous count. Of these reported deaths, 47 came in the four-month period in which reports of problems suddenly shot up.

As people in the U.S. have learned, China is the world’s leading supplier of heparin, a blood thinner often made from a substance in the intestines of pigs. As we have reported, it is commonly given to prevent blood clots in heart surgery and dialysis patients. Baxter’s heparin was contaminated with a look-alike ingredient that mimicked heparin in standard tests of drug potency and purity. The FDA identified the contaminant as a modified form of a common nutritional supplement. That substance is cheaper to produce than heparin, leading to suspicions that it may have been intentionally added somewhere along a complex and poorly regulated supply chain in China. The look-alike substance was identified using special tests, which the FDA is now asking medical device manufacturers to employ.

The FDA is recommending that doctors and hospitals be alert to any serious side effects in patients using medical devices that contain heparin and to be prepared to deliver emergency treatment. The agency also urged doctors to be on the lookout for any puzzling test results in diagnostic kits that use heparin. It’s also significant that the FDA Commissioner believes the contamination of heparin was most likely done for economic reasons and was fraudulent. The FDA is finally starting to deal with this problem. A good rule of thumb is that any product coming from China – or any component to a product made in the U.S. that came from China – should be suspect!

Source: Los Angeles Times and Reuters

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