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Octagam 5%: lifting of the voluntary recall
History of the voluntary recall
In September 2010, Octapharma Australia Pty Ltd conducted a voluntary recall of all batches of Octagam 5% and 10%. This recall was initiated after an increased incidence of thromboembolic complications associated with the use of this product in Europe and the USA. Thromboembolism is the formation in a blood vessel of a clot (thrombus) that breaks loose and is carried by the blood stream to plug another vessel. The clot may plug a vessel in the heart (myocardial infarction/ heart attack), lungs (pulmonary embolism), brain (stroke), gastrointestinal tract, kidneys, or leg (deep vein thrombus).
Changes to the manufacturing process
The increased risk of thromboembolic events has been investigated, and found to be related to manufacturing issues. In particular, some batches of the Octagam product contained increased levels of Factor XIa, an actived coagulation factor that is involved in thrombus formation.
Octapharma Australia Pty Ltd has:
- implemented changes to the manufacturing process that have lowered the levels of Factor XIa to acceptable levels
- introduced additional testing of the final product to prevent batches with elevated thrombogenic potential from being released to the market.
The new batches of Octagam 5% will be independently tested by European Official Medicines Control Laboratories (OMCL), and the issued certificate will be inspected by the TGA before a new batch is released in Australia.
The TGA has allowed the resupply in Australia of Octagam 5% since 8 August 2011 and is implementing additional monitoring activities. These requirements include the following:
- Every batch of Octagam released for supply in Australia will be approved by the TGA.
- The company must implement a Risk Management Plan that includes post marketing safety studies and the provision of updated information to healthcare professionals and professional bodies.
At this stage, the voluntary recall for Octagam 10% has not been lifted as the corrective manufacturing changes for this strength have not yet been reviewed by the TGA.
Octagam is administered as an intravenous infusion and is used in the management of a number of disorders, including immunodeficiency, which is when the body's immune system is inadequate and resistance to infectious diseases is reduced. Octagam contains immunoglobulins from human plasma that can temporarily restore abnormally low levels of immunoglobulins to the normal range.
Information for patients and health professionals
Patients who have any questions should speak to their doctor or other appropriate health care provider.
Patients and health care providers should report any adverse events that have occurred following administration of Octagam intravenous immunoglobulin solution to the TGA by: