Federal health regulators have drafted new industry guidelines that are designed to ensure the quality of heparin following the deaths of nearly 150 people several years ago when contaminated batches of the blood thinner made it into U.S. pharmacies and hospitals.
The heparin draft guidance (pdf) for industry was published by the FDA last week, focusing on oversulfated chondroitin sulfate (OSCS), as the primary ingredient of concern in crude heparin.
The agency warns that in the 2008 contaminated heparin incident, OSCS was added to heparin by a Chinese supplier in order to save money. The contaminant does not belong in the drug.
Heparin is derived mainly from pig intestines, and the FDA is urging manufacturers who receive crude heparin from other sources to test both for OSCS and the species of origin. In some cases, cow intestines have been used, which raises the risk of contamination by mad-cow disease.
According to the draft guidance, manufacturers should investigate and resolve any incidents where crude heparin tests positive for OCSC, or has questionable identity or purity. They should also reject and dispose of any crude heparin that is found to contain OCSC or other contaminants and report the incident to the FDA.
The FDA also recommends that manufacturers be familiar with the supply chain that brings them crude heparin, from the actual manufacturer to repackers and distributors. The agency says manufacturers should audit their crude heparin suppliers to make sure they conform with current good manufacturing practices.
The draft guidance still needs to be finalized by the agency, and is not legally binding.
The 2008 contaminated heparin came to the United States through Baxter International, Inc., and the resulting heparin recall, issued in January 2008, affected more than half of the supply of the drug in the United States. The contaminated heparin also surfaced in at least 10 other countries, FDA officials say.
In addition to the more than 150 deaths, there were hundreds of reports of serious adverse reactions to the heparin.
While the FDA has determined that the contaminated raw ingredients came from China, no one culprit has been identified as having placed the counterfeit ingredients into the crude heparin supply.