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Health authorities recall contaminated Hepari -

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Health authorities recall contaminated Heparin batches

The World Today - Wednesday, 23 April , 2008 12:20:00

Reporter: Barbara Miller

LISA MILLAR: Australian health authorities are recalling five batches of a common blood-thinning
drug containing Heparin after they tested positive for a potentially dangerous contaminant.

The contaminant has been associated with a series of severe allergic reactions and deaths in the
US, prompting allegations that the regulatory authority there isn't doing its job properly.

The Therapeutic Goods Administration insists that the recall of the Heparin product in Australia is
purely precautionary, but it has led to fears of a possible shortage of the life-saving drug.

Barbara Miller reports.

BARBARA MILLER: The product affected by the recall is Clexane. The Heparin contained in it has
tested positively for a dangerous contaminant.

And in the US a possible link is being investigated between intravenous forms of the drug and up to
80 deaths.

Rosanna Capolingua is the president of the Australian Medical Association:

ROSANNA CAPOLINGUA: This is a very serious situation. There have been a number of recorded deaths
due to anaphylaxis, which is a severe allergic reaction to Heparin products, to Clexane for
instance, in the United States.

BARBARA MILLER: The Therapeutic Goods Administration, which has issued the Australian recall,
insists the measure is purely precautionary.

Rohan Hammett is the TGA's director:

ROHAN HAMMETT: It's important to note that to date there have been no reports of adverse events or
untoward reactions to Clexane in Australia.

BARBARA MILLER: But there have been some reports of very serious reactions to it overseas, haven't
there?

ROHAN HAMMETT: There haven't been to this form of Heparin. Clexane is a form of Heparin that's
given as an injection under the skin. There have been reports of serious allergic reactions with
the intravenous form of Heparin in international settings. It's important to note that all forms of
intravenous Heparin in Australia have been tested for the contaminant and are free of the
contaminant.

BARBARA MILLER: The US Food and Drug Administration says the contamination of international Heparin
supplies can be traced back to a Chinese factory where the product was made.

The allegations have been strongly denied by China, which is shifting the blame back to the US
manufacturer Baxter.

Jin Shaohong, the deputy director-general of the China National Institute for the Control of
Pharmaceutical and Biological Products says if the fault lay with China, more countries would have
reported adverse reactions from the drug.

JIN SHAOHONG: In addition to the USA and Germany, more than 10 other countries also use the Heparin
ingredient that's contained over (inaudible) to produce final Heparin injection. But a new
(inaudible) report from these countries.

BARBARA MILLER: The Australian manufacturer of Clexane is Sanofi-Aventis.

The company's director of communications, Alan Brindell, says he's confident all contaminated
products have now been recalled.

ALAN BRINDELL: Sanofi-Aventis has put in a very sophisticated screening measure since the first of
April globally on all Heparin and end products, like Clexane batches, that's been able to identify
where that impurity exists and we're confident that the five batches that we've identified in
Australia are the batches that do contain the low level of impurity.

BARBARA MILLER: The Heparin scare has led to fears of a shortage in the lifesaving product, which
is commonly used to stop blood-clotting during and post-surgery and for patients who are bedridden.

But the TGA's director, Rohan Hammett, says measures are being taken to ensure demand is met.

ROHAN HAMMETT: Certainly we think there may be a shortage of Clexane in the near future. There are,
however, several other alternatives that patients and doctors can use. And we're working carefully
to try and ensure that Australia's supply chain for Heparin products is maintained for as long as
possible.

LISA MILLAR: The director of the TGA, Rohan Hammett, ending Barbara Miller's report.