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Mix-Up Behind FDA's Failure to Inspect China Blood-Thinner Plant
Date:2/18/2008

erse events linked to use of the injected heparin.

The FDA has an ongoing inspection at Baxter's plant in Cherry Hill, N.J., and at Baxter's supplier, Scientific Protein Labs in Waunakee, Wisc, Rogers said during Monday's teleconference. Starting this week, the FDA also begins investigating the correct plant in China, which makes the active pharmaceutical ingredient in heparin, he said.

"The inspection team will be conducting good manufacturing practicing inspection at the Chinese facility," Rogers said. "The inspection is designed to determine if the Chinese firm is in compliance with FDA regulations. We'll also be focusing on the firm's manufacturing process and how it adheres to the drug applications," he said.

Since the end of December, there have been about 350 reports of adverse reactions associated with Baxter's heparin product. This compares with less than 100 reports of adverse reactions in all of 2007.

Most of the reactions have taken place at hemodialysis centers, almost exclusively involving patients receiving a "bolus dose," which is a high dose administered over a short period of time, according to the FDA.

Adverse reactions included difficulty breathing, nausea or vomiting, excessive sweating and falling blood pressure, which can lead to life-threatening shock. These reactions have been seen with as few as several thousand units per milliliter of heparin, and as much as 50,000 units per milliliter.

It's not clear how long Baxter's production of injectable heparin will be stopped. The one thing that is clear is that the stoppage could lead to a shortage of heparin, which is used to prevent blood clots in such patients as those undergoing kidney dialysis and heart surgery, U.S. health officials said.

More information

For more on heparin, visit the U.S. National Library of Medici
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