Octagam intravenous immunoglobulin solutions

Related information

Later information

24 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 immunoglobulin solutions from the Australian market, due to safety concerns regarding an increased incidence of thromboembolic complications associated with the use of this product in Europe and the USA.

Background

The TGA has become aware of reports of a markedly increased incidence of serious adverse reactions associated with Octagam, an intravenous immunoglobulin (IVIg) preparation, manufactured by Octapharma in Europe. This product is supplied in Australia by Octapharma Australia Pty Ltd and is used in the management of primary and secondary immunodeficiency, as well as a number of other haematological, immunological and neurological disorders.

These adverse reactions have primarily been thromboembolic events of a serious nature, including both arterial and venous thromboembolism. Most of these events have been reported in Europe and the United States of America (USA), but at this time, there is no evidence of an increase in the number of serious adverse events of this type reported in Australia.

Although thromboembolic events are a known rare adverse event associated with the administration of all intravenous immunoglobulin preparations, as described in the prescribing information for these products, there has recently been a steady accumulation of such events reported following administration of Octagam in Europe and the USA, with a marked increase in incidence noted during the last few months of 2010.

The TGA has considered the available evidence related to the safety of this product, and with the cooperation of Octapharma Australia Pty Ltd, has agreed that as a precautionary measure, a voluntary recall of all batches of Octagam intravenous immunoglobulin solutions should be instituted in Australia, until the cause of the problem has been identified and appropriate corrective actions have been taken by the manufacturer.

As a result of this decision, all stock of Octagam intravenous immunoglobulin solutions in Australia will be recalled immediately. These products will not again be available until further notice. Similar actions are being taken by the regulatory authorities in Europe and the USA.

Consequences of this decision

Adequate supplies of alternative intravenous immunoglobulin solution products are available for clinical use in Australia, and it is not anticipated that this recall will lead to any shortage of supply in the foreseeable future. The TGA, in conjunction with the National Blood Authority and the Australian Red Cross Blood Service, will work with professional, industry and patient organisations to minimise the impact, if any, of product withdrawal on patient care.

Doctors should cease using Octagam intravenous immunoglobulin solutions immediately, and switch their patients to the most appropriate alternative treatment. Patients who have any questions should speak to their doctor or other appropriate health care provider. Health care providers may seek expert advice on appropriate use of alternative products for their patients from the Transfusion Medicine Services of the Australian Red Cross Blood Service.

Patients and health care providers should report any adverse events that have occurred following administration of Octagam intravenous immunoglobulin solution to the TGA via the Adverse Medicine Events Line (1300 134 237), online via 'Report a problem with a medicine', or using the 'Blue Card' Prepaid Reporting Form.