TGA finds contaminant in heparin

The TGA issued the safety advisory ahead of the Easter long weekend after initial testing confirmed the presence of the contaminant identified by the US Food and Drug Authority (FDA) in a heparin product distributed in Australia by Astra Zeneca.

The TGA says it is unclear whether the contamination is related to single batches or affects heparin products more generally and has commenced testing of all brands of the product available on the Australian market.

While the regulator says it has not received an increased number of reports associated with use of heparin in Australia, it advised health professionals to use heparin only where it is medically essential and to carefully monitor patients during and immediately following the drug's administration for signs of allergy or anaphylactic reaction.

The TGA was unable to issue advice about the alternative use of low molecular weight heparins, for which testing is currently being undertaken.

Last week the FDA said it had identified "over-sulfated chondroitin sulfate" as the contaminant, and was investigating whether the chemical was purposely or inadvertently added during manufacturing in China.

FDA officials said chemically manipulating chondroitin sulfate, which is widely available from animal sources, would be cheaper than getting raw heparin from pig intestines.

The FDA has received 785 reports of heparin infections, including 19 deaths in patients treated with some brand of heparin.