FDA Clarifies Its Role in Heparin Investigations

Rockville, MD (Mar. 14)-Hoping to provide a better understanding of its role in the heparin contamination investigations, the US Food and Drug Administration has posted a series of information sheets on its website. The three documents review the agency’s role in analyzing reports of adverse reactions, collecting and testing contamination samples, and implementing “import alert” systems for shipments from specified manufacturers.

When analyzing reports of adverse events, FDA uses data gathered from these reports to determine whether there is a pattern. According to the agency, only a “small percentage” of adverse events are actually reported to the Center for Disease Control and FDA by healthcare professionals and industry.

When the agency does detect a pattern and samples are gathered, these samples are tested. According to FDA, agency scientists are using “state of the art chemical methods,” also posted on its website and here, to evaluate impurities and identifies contaminants. The agency and industry are reportedly working on developing animal testing to determine whether human adverse reactions are based on allergic reactions and whether these reactions are linked to the contaminant.

When a shipment is received into the US from a specified manufacturer, FDA issues an import alert and investigators detain the shipment. The agency will remove the manufacturer from the import alert only when industry has provided the information and FDA has confirmed the information that “appropriate corrections have been made.” According to the posted documents, FDA “continues to engage with industry to help ensure adequate supply of safe heparin reaches patients.”

According to the agency, the root cause of the adverse events stemming from the heparin contamination is yet to be identified.

For more on this topic, see:

FDA 'Concerned' after Germany Reports More Heparin-Related Illnesses, March 13 edition of ePT

Active Ingredient in Baxter's Recalled Heparin Made in China, Feb. 21 edition of ePT

Baxter Voluntarily Recalls Heparin Lots, Feb. 14 edition of ePT