FDA finds fake heparin ingredient

The US Food and Drug Administration says that batches of the blood thinner heparin that were recently linked to five deaths and over 350 hospitalizations in the country may have contained a counterfeit ingredient that mimicked the real drug, according to various media reports. Last month, the agency was criticized for failing to inspect the correct Chinese facility that produced the drug's active ingredient (Marketletter February 25).

In a statement, the FDA explained that routine testing had failed to distinguish the contaminant from the drug. However, subsequent analysis using more sophisticated technology revealed that as much as 20% of the drug's active ingredient was a substitute compound, although federal officials could not confirm the exact nature of the contaminant.

FDA Deputy Commissioner Janet Woodcock said that: "at this point, we do not know whether the introduction was accidental or whether it was deliberate." Dr Woodcock added that "we don't know if any of the heparin products worldwide might contain this contaminant, and that is something we are going to be looking into." However, according to a report by Reuters, the contaminant was detected in samples at sites in Changzhou, China, and New Jersey, USA, both of which are owned by Wisconsin-based active pharmaceutical ingredient supplier Scientific Protein Laboratories.