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

Latest Issue

Latest Issue
PharmTech Europe

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

ePT--the Electronic Newsletter of Pharmaceutical Technology

Untitled Document

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


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here