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 hospitalisations in the country may have contained a counterfeit ingredient that mimicked the real drug, according to various media reports.
 
Last month, the agency was criticised for failing to inspect the Chinese facility that produced the drug's active ingredient, mistakenly reviewing another plant in its stead.
 
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 Reuters, the contaminant was detected in samples at sites in Changzhou, China, and New Jersey, USA, both of which are owned by the Wisconsin-based active pharmaceutical ingredient (API) supplier Scientific Protein Laboratories.
 
In response to the FDA's announcement, SPL said that patient safety remains its paramount concern and added that it has been working closely with both the agency and Baxter International, whose heparin product has been associated with the contamination issue, to identify the root cause of the adverse events.

The firm added that it was too early to conclude that the heparin API sourced from China and provided by it to Baxter is responsible for these events.