Step one, get FDA inspectors into China to inspect Heparin while it is being processed. Step two, inspect Heparin at the border. Friday, the FDA announced that all shipments of the active ingredients which make up the blood thinner sold by Baxter, would be tested at the border for signs of impurity. See the story on this development from Dow Jones at http://money.cnn.com/news/newsfeeds/articles/djf500/200803141503DOWJONESDJONLINE000954_FORTUNE5.htm
In an interesting example of how much more seriously the FDA is now taking the Heparin issue, at http://fda.gov they explain the current process as follows:
“COLLECT SAMPLES
FDA samples identified lots of heparin Active Pharmaceutical Ingredient (API) and finished heparin for laboratory testing.
“TEST FOR CONTAMINATION
Results from new state-of-the art chemical methods developed by FDA reveal contaminant in heparin API that conventional testing could not detect.
“TEST FOR ALLERGIC REACTION
FDA and industry are developing animal testing to determine if human adverse reactions are based on allergic reactions and to determine if there is a link to the contaminant.
“CROSS CHECK LOTS
FDA is working to identify lots linked to adverse reactions in humans with any corresponding contaminated lots. “
For a full diagram of this process, go to:http://www.fda.gov/cder/drug/infopage/heparin/analyzing.pdf
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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FDA Intercepting Heparin Before Entering US
Posted on 18th March 2008 by gjohnson in Uncategorized
Baxter recall of heparin, FDA incompetency, FDA recall heparin, heparin adverse reactions, heparin border inspections, Heparin deaths
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- Liane: Here is an article regarding the decreased potency of Heparin:http://www.newsinferno .com/archives/13187
- vtwin: I have recently stayed in a hospital where I was administeredHeparin. Are the issues resolved?Martin
- David W. Zoll: Gordon, this is not accurate. You should talk to Don Nolan and correct this entry. Most of the death...
- Imjtodd007: Could the heparin contamination cause a condition simular to Chronic Inflammatory Demyelinating...
- Lmora's blog: Just yesterday, I went down to the courthouse for an order to pull my husbands Medical Records, When I...
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