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Advisories, Alerts & Recalls

23 February 2017 – Roche clinical trial update

You may be aware that Roche is currently conducting a clinical trial of the medication emicizumab (ACE 910), which is an investigational molecule that mimics the function of factor VIII. 

HFA was saddened to learn of the recent death of a haemophilia A patient who had been participating in the trial. Roche has advised HFA that the death has been reported and assessed as unrelated to the drug emicizumab.  

HFA understands that Roche will provide further information to doctors who are involved in the trial when it becomes available. 

People with haemophilia who are participating in the clinical trial are encouraged to speak to their doctor at their local Haemophilia Treatment Centre if they have questions. 


9 March 2012 – CSL Biostate safety

CSL Biotherapies notified the TGA on 7 March 2012 that some batches of human albumin solutions manufactured by CSL in Australia prior to 25 January 2012 have been contaminated with ethylene glycol as a consequence of an equipment failure.

As a result the Therapeutic Goods Administration took steps to quarantine all batches of albumin in hospitals around Australia until further tests were conducted to ensure the safety of the product.

As human albumin is also used in the manufacture of plasma derived factor VIII, Biostate, people with haemophilia A who use this product may be concerned. However, the TGA has issued an advice today that the small amounts of ethylene glycol in Biostate are unlikely to pose a health risk. If anyone who uses Biostate remains concerned they should contact their doctor for further information.

Imported recombinant clotting factor products are not affected by this incident. CSL has also advised HFA that neither Prothrombinex – VF (PTX) nor MonoFIX (pdFIX) contain albumin.


Date last reviewed: 23 February 2017

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