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Human albumin: Quarantining of CSL human albumin (4% and 20%)

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8 March 2012

The Therapeutic Goods Administration (TGA) has taken steps today to quarantine CSL Human Albumin solutions from further use while an assessment is undertaken of the safety of these products. All hospitals and other relevant medical organisations are being advised of this action.

CSL Biotherapies notified the TGA on 7 March 2012 that some batches of human albumin solutions manufactured prior to 25 January 2012 have been contaminated with ethylene glycol as a consequence of an equipment failure. CSL is continuing to conduct further testing to quantify the levels of contamination and the extent of the batches affected but, as a precaution, TGA has put arrangements in place to quarantine stocks held by hospitals, the Australian Red Cross Blood Service (the Blood Service) and CSL from further use or issue until safety implications have been fully assessed.

CSL has advised the TGA that the levels of contamination which have been detected are very low and that, based on projections of the highest possible amounts administered and available toxicological data, adverse clinical effects appear unlikely to occur. CSL has also advised the TGA that a review of adverse event reporting has shown no evidence of a safety signal associated with the use of the product. Any toxicity due to ethylene glycol would occur acutely and delayed effects beyond 72 hours would not be expected.

As a result of this action by TGA, supplies of albumin may be limited in the immediate future. Clinicians should carefully consider the clinical need for albumin usage, as well as any alternative therapy that could be substituted, such as the use of alternative volume expanders.

The Blood Service will shortly be advising hospitals and laboratories regarding the resupply of CSL Human Albumin products, and the Department of Health and Ageing and the Blood Service have issued advice to treating clinicians regarding this product.

Over coming days, the TGA will be conducting further assessment of data provided by CSL, and will be conducting audits of CSL's manufacturing and quality assurance processes.