| Submit your comments on this article | |
| -Lurid Crime Tales- | |
| FDA finds contaminant in suspect blood-thinner - Guess who's involved | |
| 2008-03-06 | |
| Perhaps drugs ought to be primarily consumed in the country of origin, and only that in excess of that country's demand can then be shipped abroad. U.S. health officials said Wednesday they have found a contaminant in a blood-thinning drug produced by Baxter Healthcare Corp. that has been linked to more than a dozen deaths in the United States. In early February, the Food and Drug Administration launched an investigation and then a recall of some forms of the product. The scrutiny began after a spike in reports of health problems associated with heparin, a drug made by Baxter from pig intestines at plants in China and Wisconsin. Uh oh . . . . Though the cause of the problems has not been determined, FDA investigators found "a heparin-like compound -- that is not heparin -- present in some of the active pharmaceutical ingredients" in both facilities, said Dr. Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research. You mean someone went out and actively researched what would fool the quality tests on an important drug? Now who on earth would do something like that? Maybe it was accidental. The contaminant, which made up 5 percent to 20 percent of each sample tested, "reacts like heparin in some of the conventional tests used for heparin," which explains why it was not picked up, she told reporters in a conference call. No causal link between the contaminant and the adverse events has been established yet, Woodcock said. She added that it was not clear whether the contaminant was added accidentally, as part of the processing or deliberately. It also was not clear whether the contaminant was introduced in the company's plant in Wisconsin or the one in China, Woodcock said. Let's see. US authorities have no fuc&ing clue what the contaminant is after consulting plant officials I'll bet. Hmm. That leaves one other option, which involves a country with too many businessman who often have less respect for consequences on human life than the almighty Yuan. Though she said the exact structure of the contaminant has not been identified, "it is similar to heparin glycans." Glycans are polysaccharides, a complex class of carbohydrate. She added it was unclear whether other heparin products used outside the United States might also contain the product. Later this week, the agency will release recommendations on how manufacturers and regulators can screen for the contaminant, she said. How 'bout close the China plant. That would screen out lots of stuff. Last year, pet food made in China was found to be tainted with an ingredient that replaced more expensive protein and that initial tests did not identify as a contaminant. Asked if the heparin contamination could be a similar case, Woodcock said, "It's possible." Doctors have used the blood-thinner for 60 years with "no history of any problems whatsoever," said the FDA commissioner, Dr. Andrew C. von Eschenbach. Von Eschenbach said it would be "disingenuous" to expect the agency would be able to inspect "every institution in every case." Yeah, but if you use profiling and common sense, it might help cut the problem down to size. If not eliminate it altogether.
Since the agency issued its report that 19 deaths had been linked to the drug since January 1, 2007, it has received word of another 27 deaths, "but many of those do not fit our definition of this type of event," Woodcock said. In all, the FDA has received 785 heparin-linked reports of adverse events -- including difficulty breathing, nausea, vomiting, excessive sweating and plummeting blood pressure that can lead to life-threatening shock. "They're continuing to come in fairly rapidly because there has been a lot of reporting of this," she said. In a written statement, Baxter said its tests have suggested "that the root cause may be associated with the crude heparin, sourced from China, or from the subsequent processing of that product before it reaches Baxter." Meanwhile, Scientific Protein Laboratories LLC, which supplies the company with the active pharmaceutical ingredients, issued a statement saying it is working with the FDA, Baxter and outside experts to identify the cause of the adverse events. "Thus far, no conclusions have been reached about the root cause," it said. "It is premature to conclude that the heparin active pharmaceutical ingredient sourced from China and provided by SPL to Baxter is responsible for these adverse events." No it isn't. It said that its voluntary recall of suspect product was being made as a precaution. And the alternative to a voluntary recall of this "suspect" product here? Yeah, I thought not. | |
| Posted by:gorb |
| #9 ...a drug made by Baxter from pig intestines... Boy, that'll piss off the muzzies. Why are we still buying shit from China? |
| Posted by: DarthVader 2008-03-06 17:18 |
| #8 Plastic crap and textiles from China are bad enough but food and drugs? What that tells me is that U.S. businessmen and their pet politicians are just as contemptuous of human life as their Chinese counterparts. At the very least these products should be clearly labeled as being from China. Then consumers could ask their doctors or pharmacists for alternatives. |
| Posted by: Abu Uluque (aka Ebbang Uluque6305) 2008-03-06 14:30 |
| #7 #1: investigators found "a heparin-like compound -- that is not heparin -- present in some of the active pharmaceutical ingredients" in both facilities I missed that. Does it mean that the US-side is involved as well? It seems impossible to me that they would tinker with the FDA-approved formula. Is it possible that a supplier is messing with the component ingredients? Who is the supplier - China perhaps? |
| Posted by: gorb 2008-03-06 14:10 |
| #6 I recall vaguely that artificial sweetners such as Sacchrin are Polyglycols (so is antifreeze) So what's the "Contaminant? Antifreeze? it's sweet to the taste. |
| Posted by: Redneck Jim 2008-03-06 14:06 |
| #5 Part of the problem is that there are now plenty of raw materials that are produced only in China. So there are no alternative sources to go to when this kind of issue comes up. A dozen deaths in the U.S. alone? Over what period of time, I wonder. And how many deaths and health problems occurred due to this that were not reported to the FDA as being associated with heparin. |
| Posted by: trailing wife 2008-03-06 12:59 |
| #4 'Way to tarnish the brand equity, there, boys! |
| Posted by: Mike 2008-03-06 12:39 |
| #3 And by "a heparin-like compound -- that is not heparin", we mean lead. |
| Posted by: SteveS 2008-03-06 09:43 |
| #2 Might be wayfarin, which is also a blood thinner and is used to kill rats. |
| Posted by: lotp 2008-03-06 09:27 |
| #1 investigators found "a heparin-like compound -- that is not heparin -- present in some of the active pharmaceutical ingredients" in both facilities, |
| Posted by: Icerigger 2008-03-06 09:24 |