02 | 20 | 2008 Posted By Regan Zambri & Long

FDA Mix-Up Results in Unapproved, Dangerous Heparin Ingredients, 350 Adverse Medication Reactions

According to a recent article in the Washington Post, an error at the U.S. Food and Drug Administration (FDA) has resulted in the approval of the wrong Chinese drug manufacturing facility.  That error may be partly to blame for approximately 350 adverse reactions and 4 potential fatalities which have been linked to Heparin manufactured by Baxter Healthcare Corporation.  Heparin is a powerful blood thinner.  According to the Post, it now appears that the corporation manufactured its product with pharmaceutical ingredients imported from a Chinese manufacturer that accidentally escaped FDA inspection and approval.

Federal law does not require inspections of foreign drugmakers, but the FDA typically does inspect those entities before a new drug or active drug ingredient manufactured in a foreign facility is allowed in an FDA-approved prescription medication.  The agency's inspection doesn't necessarily always include an on-site visit.

One member of Congress quoted in the Post has also expressed concern that the FDA doesn't seem to know how many foreign drug manufacturers exist, as one agency database identifies 3,000, while another database identifies 7,000. 

According to the article, Baxter Healthcare Corporation, manufacturer of the tainted Heparin, sent its own pharmaceutical inspector to the Chinese facility six months ago to ensure manufacturing protocol was being followed.  Baxter employees had previously detected variations between different lots of the substance which were manufactured in China. 

Previously on the DC Metro Area Medical Malpractice Law Blog, we have posted articles related to:

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