As an update to my post back on February 18 2008 about adverse reactions and deaths in the USA from cheap, contaminated, counterfeit Heparin ingredients coming out of an unregulated, never-inspected factory in China, I note that the Australian Therapeutic Goods Administration Agency has now issued an “Urgent Safety Advisory” regarding Heparin here in Australia.
In the US, the heparin was said to have been contaminated by unregulated “consolidators” in China with a less expensive ingredient derived from animal cartilage, [which] isn’t approved in the U.S. for medical use. The contamination in the Australian batches is also reported to have come from China.
From the recent Australian TGA Bulletin: “Initial results of the TGA’s testing … have confirmed the presence of the contaminant identified by the FDA in a heparin product distributed in Australia by Astra Zeneca. It is unclear whether the contamination is related to single batches or affects heparin products more generally.”
The Australian reports:
March 26, 2008 – AUSTRALIA’S medicines regulator has issued an urgent safety warning over the use of some anti-clotting drugs, after tests revealed contamination by the substance suspected of causing hundreds of serious adverse reactions and even deaths in the US.
Drug giant AstraZeneca is expected to ask the Therapeutic Goods Administration today to approve a recall of 100,000 doses of heparinised saline, after the contamination alert was confirmed late last week.
Right now it appears that AstraZeneca is only recalling one specific type at this point, the version mainly injected into IVs, Central Lines, Portacaths and the like to keep them clear.
“The TGA said it was ‘unable to issue advice’ about the use of more processed drugs called low molecular weight heparins, as testing of these was continuing.
“Alex Gallus, professor of haematology at Flinders University, said that if low molecular weight heparins were found to be contaminated also, ‘then we have a real problem, because we have very few alternatives to them at this time’.”
Not to be an alarmist, but I have the feeling that this is just the tip of the iceberg.
Australia is not alone – today’s Wall Street Journal reports that Heparin is also being recalled in France, Italy and Denmark. It had already been recalled earlier in the USA and Germany.
Y’all are going to get tired of me saying this, but this is my soapbox and I’ll say it ’till someone listens. Our big pharmaceutical companies have no business sourcing drug ingredients from China until China gets its act together. China is fundamentally incapable of safeguarding the safety and efficacy of the products they make. And I don’t necessarily trust our regulators to pick up on the shoddy drugs and do the right thing in a timely manner when this cr@p does hit our shores. So bear with me here, for the fourth time…
Memo to big Pharmas: Forget this ‘lowest bidder’ shit. Get the f#&k out of China.
• For more details and collections of links on this, see my previous posts here, here and here.
Disclaimer: Remember I am in no way, shape or form a medical person, so if any Aussies have questions or concerns please take the advice of Dr Paul Bennett, from the Australian distributor Astra Zeneca, regarding intravenous Heparin products: “We hope that those people will realise that this drug may present a problem … If they would like to go back to their pharmacist or to the doctor then they will get appropriate advice on what to do in this situation.”