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Heparin Debaucle Reveals FDA Flaws

Posted by Jane Akre
Tuesday, February 19, 2008 11:59 AM EST
Category: Major Medical, Protecting Your Family
Tags: Defective Drugs, FDA and Prescription Drugs

The FDA didnt inspect the plant inChina where contaminated heparin is made.  

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Last week it was revealed that the FDA failed to inspect the Chinese factory that produces heparin, the contaminated blood-thinning drug that's under a massive U.S. recall.

Now the FDA is confessing it was not inspected because of a paperwork error and confusion with a factory that had been inspected.

The revelations underscore the cracks in a system of safety regulation and inspection of medical imports from China.

There is no FDA requirement that every foreign plant producing pharmaceuticals for this country be inspected, though the agency says it "generally" does in an email to the Chicago Tribune.   And don't rely on China either. The Beijing government does not routinely inspect plants producing exports.

When a change in a plant's ownership occurs or a new product is being produced, an on-site visit may be made, however often documentation can take the place of an inspection.

The key active ingredient, derived from an enzyme in pig intestines, was produced in China for Baxter International Inc. The ingredient comes from Scientific Protein Laboratories of Waunakee, Wisconsin, which is a co-owner in the China plant.

So far, there have been more than 350 adverse events reports into the FDA since the end of 2007 including serious allergic reactions and low blood pressure, difficulty breathing, nausea, vomiting and sweating. Four people taking heparin have died.  The drug is given to millions in IVs to minimize blood clots and widely used during surgery and in kidney dialysis. The FDA says doctors should use an alternative heparin. 

Baxter stopped selling the multiple-dose vials of heparin in early February.   

The reason for the reactions is still a mystery so FDA regulators are off to inspect the Chinese plant this week in an investigation deemed "one of its top priorities."The Wisconsin plant and Baxter plant in Cherry Hill, New Jersey will also be inspected.

Last year the agency says it inspected 250 foreign pharmaceutical plants, 13 of those were in China. Senate investigators discovered that from 2002 to 2007, the FDA made 75 inspection in China.

Meanwhile heparin's main competition, Schaumburg Illinois based APP Inc., had had its Chinese plant inspected the FDA reports.

Customers with questions may contact the Center for One Baxter at 1-800-4-BAXTER (1-800-422-9837). Representatives will be available twenty-four hours a day, seven days a week.

Baxter Healthcare says it sells 35 million units of heparin sodium injection multi and single dose vials per years in the U.S. with an annual sales of $30 million. #


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