• With Eye on Tainted Chinese Heparin Scandal, FDA Finalizes Quality Monitoring Guidance

    The US Food and Drug Administration (FDA) has released a finalized guidance document recommending certain practices for monitoring the quality of crude heparin, a response to systemic failures in quality monitoring in 2007 and 2008 that resulted in the deaths of nearly 150 Americans. Background: Scandal and Death The final guidance is similar to one released in February 2013 and aims to "help active pharmaceutical ingredient (API) manufacturers, pharmaceutical and medic...
  • FDA Plans Multi-Year Investigation Into Rare Side-Effect of Heparin

    The US Food and Drug Administration (FDA) has announced that it will give researchers a quarter of a million dollars to help identify the source of a major safety risk now affecting heparin products. Heparin, a mixture of non-standard-length polysaccharides, acts as an anticoagulant under normal circumstances. However, a notable side effect known as heparin-induced thrombocytopenia (HIT) results in a decrease of platelets in the blood resulting in the release of abnormal...
  • EMA Releases Draft Guideline on Biosimilar Heparin Products

    The European Medicines Agency (EMA) has released a draft scientific guideline on the development of biosimilar low-molecular-weight heparins, a type of medical product often used in surgical settings as an anticoagulant and incorporated into a wide range of products. The guideline specifically pertains to two types of heparin: low molecular mass heparins (LMMH) and low molecular weight heparins (LMWH), both typically sourced from the intestinal mucosa of pigs. Non-Cli...
  • USP Plans to Launch Updated Heparin Standard to Ensure Safety

    • 23 May 2012
    The US Pharmacopoeia (USP) is announcing the impending launch of an updated standard meant to further boost the safety and quality of Herparin, contaminated supplies of which were associated with numerous deaths in 2007 and 2008.  "The third and latest round of revisions to USP's heparin standards will bring even greater sensitivity and precision to the tests and reference materials used to help ensure heparin quality," said USP in a statement. "In response to reque...
  • Chinese Suppliers Tied to Tainted Heparin

    • 23 February 2012
    Fourteen Chinese companies have been linked to contaminated heparin, an anticoagulant commonly used during surgical procedures and dialysis, according to a Wall Street Journal report . The US Food and Drug Administration (FDA) added these companies to an import list allowing FDA to stop shipments at the border. That list already included eight other Chinese suppliers who were believe to have provided tainted raw materials for the making of heparin. The Wall Street J...
  • Guidance for Industry on Heparin Released by FDA, Bookend to Heparin Scandal

    The US Food and Drug Administration (FDA) released new draft guidance for industry on ensuring that a company's heparin supply meets quality standards. The draft guidance, Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality , comes just four years after tainted Chinese-sourced Heparin killed dozens of US citizens. The draft guidance aims to "help API manufacturers, pharmaceutical and medical device manufacturers of finished products, repacker...