FDA Intercepting Heparin

Step one, get FDA inspectors into China to inspect Heparin while it is being processed. Step two, inspect Heparin at the border. The FDA has 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:

Dow Jones Story

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:

FDA Process

Next: FDA Plans Full-Time Staff in China

For information on the recall, click here:

FDA Information

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For Our Latest Information on Heparin go to our Blog:

Heparin Glossary

TOPICS:

• Manufacturers may have received contaminated Heparin as early as 2006
• Reports of serious drug reactions hit record
• Heparin - Misdiagnoses of HIT
• Heparin-bonded Catheters
• Adverse Heparin Reactions: Symptoms and Side Effects
• Drug Stayed on hospital shelves despite recall
• Regulator says hospitals need strict heparin rules
• The New England Journal of Medicine: MIT Study
• FDA: Heparin Warning
• Contaminated Heparin Can Do More than Kill
• Heparin Lawsuit: Areas of Inquiry
• FDA Press Releases
• Scott v. Baxter Lawsuit
• Reporting Heparin Problems
• Understated Adverse Reactions
• Baxter Widens Heparin Recall
• FDA Intercepting Heparin
• FDA Plans For Full-Time Staff in China
• Heparin Purity - China Doesn't Seem to Care
• Baxter Didn't Know About Absence of Inspection
• German Heparin Also Contaminated
• Heparin Contaminant Identified
• Heparin Recall Timeline
• Food and Drug Administration Globalization Act of 2008