KEY POINTS:
New Zealand's supply of blood thinner heparin has been tested by manufacturers and is not contaminated, the medicine safety agency Medsafe says.
The assurance follows a warning from the US Food and Drug Administration in New York that contaminated blood thinner from China linked to 81 deaths in
the United States is present in drug supplies in 11 countries, including New Zealand.
Medsafe spokesman Dr Stewart Jessamine said the agency was first told of the problem in January and has been in close contact with the FDA since.
He said Medsafe's American counterpart had released test methods to check the purity of heparin.
"We in turn have required manufacturers selling this product in New Zealand to test it," he told Radio New Zealand.
It is not known if independent testing has been carried out and Medsafe have so far not returned phone calls on this matter.
No contamination was found in products currently on the market, he said.
"There was one batch of product of low molecular weight heparin, which internationally was found to contain that contaminant, and that product hadn't yet made it out to patients."
It was quarantined and withdrawn, he said.
"We're confident that the product that is available in New Zealand for use in patients through hospitals and doctors, is not at risk through contamination," he said.
Dr Jessamine said the practice surrounding the use of heparin in New Zealand was "significantly different" to that of the US.
Medsafe has also asked hospitals to report any "unusual events" that would suggest product was contaminated.
No such events have been reported.
The FDA has sent a warning letter to Changzhou SPL, the Chinese plant identified as the source of the contamination.
In it the FDA said the plant used unclean tanks to make heparin, accepted raw materials from an unacceptable vendor and had no way to remove impurities, The New York Times reported.
The FDA identified 12 Chinese companies that have supplied contaminated heparin to Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the US.
But it does not know the original source of the contamination or where it entered the supply chain, the Times said.
The contaminant has been identified as oversulfated chondroitin sulfate, a "cheap fake additive" that can be detected only through sophisticated testing, the paper said.
A Chinese official has disputed the assertion the blood thinner has caused death, but conceded that heparin produced in China contains a contaminant.
- NZPA
