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China Plant Implicated in Heparin Scare Never Inspected by the FDA

Posted By Dr. Mercola | February 18 2008 | 1,183 views
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The U.S. FDA has never inspected the Chinese manufacturing facility implicated in the Baxter heparin. Baxter suspended production of its blood-thinning drug heparin in multi-dose vials following the deaths of four patients in the U.S. and hundreds of reports of severe allergic reactions, including rapid drop in blood pressure, burning sensations, headaches, throat swelling and shortness of breath.

Baxter sources the drug's active pharmaceutical ingredient from an undisclosed U.S. supplier who operates a plant in China, and another one in the U.S. But the FDA has now revealed that the Chinese plant did not actually undergo a pre-approval inspection by the agency, as is required before a manufacturing facility is authorized to supply drug ingredients to the U.S.

The Chinese facility may or may not be behind the heparin adverse reactions. However, the situation highlights the concern in the U.S. over the mounting number of foreign-sourced drug ingredients and the FDA's questionable ability to effectively monitor quality control.

Sources:

  LabTechnologist.com February 14, 2008
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Disclaimer: The entire contents of this website are based upon the opinions of Dr. Mercola, unless otherwise noted. Individual articles are based upon the opinions of the respective author, who retains copyright as marked. The information on this website is not intended to replace a one-on-one relationship with a qualified health care professional and is not intended as medical advice. It is intended as a sharing of knowledge and information from the research and experience of Dr. Mercola and his community. Dr. Mercola encourages you to make your own health care decisions based upon your research and in partnership with a qualified health care professional.

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*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. If you are pregnant, nursing, taking medication, or have a medical condition, consult your physician before using this product.

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Disclaimer: The entire contents of this website are based upon the opinions of Dr. Mercola, unless otherwise noted. Individual articles are based upon the opinions of the respective author, who retains copyright as marked. The information on this website is not intended to replace a one-on-one relationship with a qualified health care professional and is not intended as medical advice. It is intended as a sharing of knowledge and information from the research and experience of Dr. Mercola and his community. Dr. Mercola encourages you to make your own health care decisions based upon your research and in partnership with a qualified health care professional.

†The World's #1 Natural Health Website claim is based upon Alexa Natural Health Website rankings.

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