New Guidelines to Avoid Heparin Contamination

by Sheela Philomena on  February 11, 2012 at 11:01 AM Drug News
  •   Print
  •   Share
  •   Comments
  •  Text 
US regulators on Friday issued new guidelines for safe production of blood thinner heparin.

Heparin, a blood thinner used by millions of patients during kidney dialysis and heart surgery to prevent blood clots, is normally produced from pig intestines.

After reports of allergic reactions to heparin began appearing in November 2007, the US Food and Drug Administration found that a substitute synthetic compound called oversulfated chondroitin sulfate (OSCS) had caused the toxic reactions.

Chinese officials rejected the FDA's conclusions, saying the chemical had nothing to do with the allergies and deaths, but the FDA began testing heparin imports for OSCS in 2008 to assure safety of the drug stocks.

The new guidelines are directed toward companies who use crude heparin to manufacture drugs and medical devices.

Manufacturers are urged to test the origin of crude heparin to make sure it comes from pigs, test for OSCS in each shipment before using it, and know who handles the crude heparin along each step of the process.

"Substitution of non-porcine sources of crude heparin raises concerns," said the FDA, particularly due to the risk of mad cow disease, or bovine spongiform encephalopathy, infiltrating products.

"The control of the animal origin of crude heparin is critical to ensure the safety of drugs and devices that contain heparin and to protect public health."

The guidelines are subject to a 60-day review and comment period and are not legally enforceable during this period.

Source-AFP

 Email Email   RSS Feeds RSS Feeds   Print this page Print   Save this page Save   Link Link   Syndicate Syndicate   Comments Comments   Bookmark and Share
 
Comment & Contribute
Comments should be on the topic and should not be abusive. Comments are normally moderated and are reviewed after they are posted.
* Your comment can be maximum of 2500 characters

Notify me when reply is posted
I agree to the terms and conditions
  
If you have a question about health related issues, you can now post it in our Ask An Expert section on our community website Medwonders.com and get answers from our panel of experts.
X
  • Health News Index
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
News Archive
Date :
Category :
Keyword :
  • News Quick Links
News Central Health Watch
Latest Health News Health In Focus
News Category (500+) Breaking Health News
Popular News Celebrating Life
Health News and Press Release Medindia - Exclusive
News Photo Gallery India Special
News Video Gallery Lifestyle and Wellness
News From Other Resources
News Categories:  
Sexual Health Center

Drug Related News

» New Quality Standards in Medicines » Drug for Irregular Heartbeat Gets Green Signal
» Schizophrenia Drug Differentiates Cancer Stem Cells into Less Threatening Cells » Docs Who Seldom Meet Drug Reps Continue to Prescribe Drugs With FDA “Black Box” Warnings
» Revision in Quality Standards for Heparin » Acne Drug Users At High Risk of Developing Eye Infections
» Patients Who Take Antidepressants When in ICU More Likely to Die » New Tablet Coating Product by Ideal Cures, In Geneva
Read More >>