FDA 'Concerned' after Germany Reports More Heparin-Related Illnesses - Pharmaceutical Technology

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FDA 'Concerned' after Germany Reports More Heparin-Related Illnesses

ePT--the Electronic Newsletter of Pharmaceutical Technology

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Rockville, MD (Mar. 6)—Concerns over contaminated heparin product worsened as US officials announced dialysis patients in Germany have fallen ill after using a different brand of the blood thinner than was already being recalled.

Just one week after Baxter International announced it would voluntary recall all of its remaining lots and doses of heparin sodium injection multidose, single-dose vials, and HEP-LOK heparin flush products, which were linked to 19 deaths in the United States, FDA confirmed that Germany is recalling heparin made by RotexMedica GmbH, a German company that uses a different supplier of raw heparin ingredients than Baxter does. Baxter receives its heparin material from China, the world’s largest heparin supplier. It is unknown whether RotexMedica also received its supply from China.

The incidents appear to be caused by a contaminant that mimics heparin so well that it is not detected by standard drug-quality tests. In response, FDA is urgently pushing for companies to start using advanced analytical techniques to ensure drug products are free of this contaminant and has posted instructions on its website on how manufacturers can do these additional tests to identify the fake ingredient.

“We’re concerned about, worldwide, this contaminant in heparin and making sure it stays out of the heparin supply,” said Janet Woodcock, FDA chief medical officer, to the Associated Press.

Reports have stated that German officials have not confirmed that the heparin product by RotexMedica has been recalled. Meanwhile, as reported in the February 28 edition of ePT, APP Pharmaceuticals has boosted its manufacture in efforts to keep up with market demand.

For more on this topic, see:

Active Ingredient in Baxter's Recalled Heparin Made in China, Feb. 21 edition of ePT

Baxter Voluntarily Recalls Heparin Lots, Feb. 14 edition of ePT


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