US issues guidelines to avoid heparin contamination

February 10, 2012

Four years after US drug-maker Baxter International's blood thinner heparin was contaminated in China, causing dozens of deaths, US regulators on Friday issued draft guidelines for safe production.

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, and aim to "provide additional clarification to questions and inquiries received from industry," an FDA spokeswoman said.

The regulatory agency "continues to monitor and sample incoming heparin," she added.

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 guidelines, 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.

Related Stories

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.