Voluntary recall of Octagam® intravenous immunoglobulin solutions
27 September 2010
The Therapeutic Goods Administration (TGA) advises that Octapharma Australia Pty Ltd has agreed to a precautionary voluntary recall of all batches of Octagam intravenous immunogobulin (IVIg) solutions from the Australian market.
This is due to safety concerns regarding an increased evidence of thromboembolic complications associated with the use of this product in Europe and the USA. The TGA website has more information about this voluntary recall.
Q&A: Thromboembolic Adverse Events Related to Octagam® 38 KB
None of the batches distributed in Australia have been associated with reports of thromboembolic episodes at an incidence beyond that expected.
Clinicians, however, should use their own professional judgement to determine whether individual patients—who may be an increased risk of developing thromboembolic complications as a result of their underlying illness—require closer follow-up and monitoring.
Octagam® will not be available for prescription and patients who require ongoing therapy with IVIg will be issued an alternate TGA approved IVIg.
Intragam® P is still available and there are no changes to its indications for use, supply or distribution.
Flebogamma 5% DIF, Lateral Grifols, will be available under the National Blood Arrangements.
