FDA Finds "Heparin-like" Contaminant in Heparin API

The FDA has found what it is calling a “heparin-like” compound in the active pharmaceutical ingredient (API) of heparin that is not heparin.

Janet Woodcock, acting director of the FDA’s Center for Drug Evaluation and Research, said in a March 5, 2008 media conference call that, after advanced testing, the FDA has identified the “heparin-like” substance in concentrations making up 5 to 20% of the APIs that were tested. She said that the substance reacted in a way that was similar to heparin, which is why it was not detected earlier.

Woodcock also said that there was no direct link yet made between the contaminant and the recent reports of severe adverse reactions to the drug. The FDA does not yet know where the contaminant was introduced, or if the addition was deliberate or accidental.

The API for Baxter Healthcare’s (Deerfield, IL) recalled heparin products are produced by Scientific Protein Laboratories’ (SPL, Waunakee, WI) manufacturing sites in Wisconsin and Changzhou, China. The FDA would not specify which manufacturing site the contaminated API originated from.

The FDA has received reports of 46 deaths of people who have used heparin products, and 785 adverse reactions to heparin products. They have confirmed that 19 of the deaths and 350 of the severe reactions are related to the drug.
On February 29, 2008, Baxter recalled multi-dose vials, single-dose vials, and HEP-LOCK heparin flush products. Although there have been no reports of adverse reactions related to the single-dose vials of heparin or HEP-LOCK, as had been reported with the multi-dose vials, Baxter has recalled them as a precaution because they have the same API as the multi-dose vials.