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The following information has been provided by Haemophilia
Foundation Australia (HFA) to individuals who may be affected by the recall of several
batches of ProthhrombinexTM in 1992. HFA is not qualified to provide clinical,
scientific or legal advice. HFA strongly encourages consultation with treating
clinicians to discuss any implications for individuals who may be affected by this
situation.
In May 2003 HFA commenced a process of inquiries to CSL, Australian
Red Cross Blood Service (ARCBS) and governments about the circumstances of a recall of
several batches of Prothrombinex in 1992. The recall was undertaken by CSL (then
Commonwea1th Serum Laboratories) because plasma that had tested antibody positive to
hepatitis C had been forwarded in error to CSL and then used in the manufacture of
ProthrombinexTM (Factors II, IX, and X), used for the treatment of haemophilia B.
This blood banking error was investigated, amongst other things, by the Expert
Advisory Group on Hepatitis C and Plasma in 1990 chaired by Professor Bruce Barraclough
which reported in May 2003(1), and later by the Senate Community Affairs Committee Inquiry
into Hepatitis C in 2004(2).
Although hepatitis C antibody testing commenced in February 1990, it was known these
first generation tests did not detect all at risk plasma. Whilst decisions had been made
that other plasma products could be treated sufficiently to inactivate hepatitis C and
HIV, there remained a risk for ProthrombinexTM because it was heat treated to 60oC at
the time, effective against HIV, but not hepatitis C. It was for this reason
Prothrombinex, and not other plasma products, was recalled following recognition of the
blood banking error. A safer product, ProthrombinexTM (HT), heat treated to 60oC and
effective against hepatitis C, was available from August 1993.
Of major concern to HFA was that this blood banking error had been reported two
years after the product had been manufactured, and the implicated ProthrombinexTM batches
were likely to have been used by patients before the recall occurred. We know the
recalled batches 00301, 01501 and 02201 had been distributed to each State/Territory,
except the Northern Territory, and that not all the product was returned after the
recall or traced.
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CSL and ARCBS have indicated there is evidence to suggest users of these products
may not have been exposed to greater risk than they had been with other batches. HFA
has been advised there were no reported cases of hepatitis C transmission from
ProthrombinexTM resulting from this incident. Crucial to our enquiries was whether
patients who used any of the implicated treatment product had been told of potential
compromises or risks to their health. Recall letters were sent in 1992 to the Medical
Directors and Chief Pharmacists of all hospitals that had received the particular
batches, however HFA believes some or all patients had not been informed. HFA's key
objective is to establish a process for people who may have used this product to access
accurate information about the potential effects on their health, should they wish to
know.
HFA has taken steps to ensure people have access to this information in an
appropriate clinical setting. HFA has encouraged CSL and ARCBS to provide relevant
advice to haemophilia clinicians so that clinicians would provide information to their
patients and follow up as appropriate. HFA has now been informed that haemophilia
clinicians throughout Australia recently received a communication from CSL and ARCBS
with the relevant information.
References:
1. Report of the Expert Advisory Group on Hepatitis C and Plasma in 1990
www.nba.gov.au
2. Senate Community Affairs Committee Inquiry into Hepatitis C in 2004
www.aph.gov.au/Senate/committee/clac-ctte/completed_inquiries/2002-04/hepc/index.htm
UPDATE on ACT situation:
Staff at the Haemophilia Centre at The Canberra Hospital will be checking hospital
records for issues of ProthrombinexTM around 1992 to see whether any patients may have
been at risk. Depending on their findings, some follow-up action may be taken.
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