MIT report proves type of contaminant in Chinese heparin

Posted: December 3, 2008 Author: Jennifer Walker-Journey Pharmaceutical

A team of researchers from the Institute of Technology (MIT) has confirmed that was, in fact, the contaminant in heparin that was manufactured in and triggered serious allergic reactions that caused more than 80 Americans to die and hundreds more to be sickened earlier this year, according to ABC Action News.

Researchers identified the contaminant last April and noted how it could lead to severe allergic reactions. This new MIT report documents the reactions and specifically links them to batches of that were manufactured in ’s facility. The findings were published in the New England Journal of Medicine.

In an effort to provide guidance on U.S. quality standards and avoid life-threatening contaminations of drugs imported into the U.S., the has begun setting up foreign offices and placing more than 60 food and drug regulators worldwide. Last month, the agency opened its first foreign offices. Three of those first offices were located in China.

Health and Human Services Secretary Michael Leavitt said the foreign offices will send a clear message to producers that if they want access to the American market, they must make products that meet a higher standard of quality.

Related posts:

  1. Researchers find new method to detect contaminant in heparin
  2. FDA will not name Chinese plants that supplied tainted heparin
  3. FDA opens first foreign office in Beijing this week
  4. Lawmaker questions FDA investigation of heparin scandal
  5. Contaminated heparin removed from Cinnicinnati plant