About Careers Internship MedBlog Contact us
Medindia LOGIN REGISTER
Advertisement

New Guidelines to Avoid Heparin Contamination

by Sheela Philomena on February 11, 2012 at 11:01 AM
Font : A-A+

 New Guidelines to Avoid Heparin Contamination

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.

Advertisement

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.
Advertisement

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
Advertisement

Advertisement
News A-Z
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
What's New on Medindia
Test Your Knowledge on Liver Transplantation
Organ Donation Week 2022 - 'Take the Pledge to Save Lives'
Test your Knowledge on Heart Transplantation
View all
Recommended Reading
News Archive
Date
Category
Advertisement
News Category

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.

More News on:
Anticoagulants Pulmonary Embolism Dioxins and Related Compounds 

Most Popular on Medindia

Color Blindness Calculator How to Reduce School Bag Weight - Simple Tips Selfie Addiction Calculator Hearing Loss Calculator Iron Intake Calculator A-Z Drug Brands in India Blood Pressure Calculator Indian Medical Journals Drug Side Effects Calculator Daily Calorie Requirements
This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use