Article date: July 2011
After an in-depth review of available safety and quality data, the suspension of the licences (marketing authorisations) for Octagam (intravenous human normal immunoglobulin 5% and 10%) has now been lifted. This follows advice from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
In September 2010, CHMP recommended suspension of the licences for Octagam after an increased frequency of the known risk of thromboembolic adverse events (eg, stroke, myocardial infarction, and pulmonary embolism; see Drug Safety Update October 2010).
The increased risk of these events was related to a manufacturing defect, which led to increased levels of thrombogenic substances in the finished Octagam product. A number of measures have now been implemented, including an improved manufacturing process and a thrombogenicity testing before batches of Octagam are released to the market. CHMP was reassured that future production of Octagam would meet the required quality standards and therefore recommended lifting the suspension.
As with all medicines, we will continue to closely monitor the safety of Octagam in the UK.
Advice for healthcare professionals includes:
after implementation of new safeguards and improvements to the manufacturing process for Octagam, the benefits of this product are considered to outweigh the risks.
as with all medicines, any suspected adverse reactions should be reported at www.yellowcard.gov.uk.
European Medicines Agency: European safety review for Octagam
Article citation: Drug Safety Update July 2011, vol 4 issue 12: S1.
Published 11 December 2014