FDA health officials have found a contaminant in a blood-thinning drug, Heparin produced by Baxter Healthcare Corp. The drug has been linked to many deaths in the United States.
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FDA health officials have found a contaminant in a blood-thinning drug, Heparin produced by Baxter Healthcare Corp. The drug has been linked to many deaths in the United States.
Heparin is commonly used in dialysis to prevent clotting of the blood when it circulates in a dialysis machine. It makes the blood thinner and thus reduces the loss of the blood during dialysis. Anemic patients can’t afford this blood loss as it could prove fatal for them.
The most common reactions that are developed are difficulty in breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure. All these can prove fatal and thus further analysis was done on the effect of this drug.
Initial reports had found a Chinese plant to be the place from where the problem had originated. FDA conducted a series of tests of the active ingredient produced in China and found a contaminant in 20 of 28 samples.
Scientists don't yet know exactly what the contaminant is, but it has been observed that it mimics heparin so closely that standard drug-purity tests won't catch it.
Though the exact structure of the contaminant has not been identified, "it is similar to heparin glycans." Glycans are polysaccharides, a complex class of carbohydrate.
In January, Baxter had voluntarily recalled nine lots of its injectable heparin sodium injection in 1,000-unit vials, after reports of adverse reactions.
Dr. Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research said that later this week, the agency will release recommendations on how manufacturers and regulators can screen for the contaminant.
It also was not clear whether the contaminant was introduced in the company's plant in Wisconsin or the one in China, Woodcock added.
Baxter supplies about half the heparin used in U.S. Heparin generates about $29 million in annual revenue for Baxter, less than 1 percent of the company's total revenue.
Meanwhile doctors are being recommended to use lesser dosage and alternative drugs in order to ensure that there are lesser cases of allergic reactions due to this drug.
I Just Don't Get It
I just don't get it. How much money do these companies save by purchasing animal based drugs from China? Don't we have enough slaughtered pigs in America regulated by government agencies? We don't have a perfect system but still, it beats rural mom & pop animal chop shops in China where hygiene is the last thing on people’s minds.
WE ALL know that China "knocks off" everything from Prada handbags & Rolex watches to CDs & DVDs. They’re truly masters of illusion when it comes to products. They’ve even to knocked off UL labels and put them on faulty extension cords used extensively during Christmas.
Manufacturing companies in communist China are under tight & complete government approval, from financing & land sales to "ownership" selection. So ultimately it’s the Chinese government that has no qualms about pirating or tainting products so long as they make money. I can understand importing the cheap products we love to buy at Wal-Mart but I am shocked by how many products that are ingested into the human body originate from China. Even sucking candy!
Personally I would NEVER intentionally ingest any of these products and I think until China cleans up it's act, America should ban them from being sold here. The Europeans and Americans have established standards that will take generations for China to achieve. Their first step has to be GENUINE desire and that, again, is the furthest thing fro their minds.