Adverse Effects of Contaminated Blood Thinner
On Friday, the FDA said that the medicine heparin and its elements would be checked at the American border for an impurity believed to be connected to nineteen fatalities. This is just the newest development in the inquiry into hundreds of allergic reactions associated with Baxter International’s heparin injections.
20 out of 28 samples of raw heparin from Baxter’s main supplier, a Chinese factory belonging to Scientific Protein Laboratories, were found to be contaminated.
In Germany, another brand of heparin was taken off the market when 80 cases of illness were reported. Apparently a Chinese supplier was the source here, too. China in fact, is the world’s main producer of heparin, which is made from pig intestines. The raw constituents of the drug start from small family-run operations near slaughterhouses, go through middlemen, and end up in factories such as SPL’s. These places have not been examined by the FDA, as this is still being negotiated with the Chinese authorities.
The FDA said that no additional cases had succumbed since the last batch of contaminated heparin had been recalled, and only two allergic responses had been reported.
It is not known as yet just what the impurity is since it is so similar to heparin that it is difficult to identify and isolate. FDA drug chief, Dr. Janet Woodcock says that the contaminant will soon be identified and they will then find out whether the adulteration was deliberate.
Recently, the FDA asked the other American heparin makers to use advanced methods of ensuring purity. Consignments from other countries will be examined by the FDA. Woodcock feels that the control on heparin imports is an added safety measure, and will offer a clear view of the situation and help to locate the origin of the contaminant.
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