Octagam withdrawn following safety review

Octagam (human normal immunoglobulin) is being withdrawn across Europe following an unexpected increase in the rate of thromboembolic events in patients receiving Octagam 5%.

The increased reports of thromboembolic reactions associated with the immunoglobulin, including stroke, myocardial infarction and pulmonary embolism, prompted Germany and Sweden to suspend its marketing authorisation earlier this month.

The European Medicines Agency (EMA) subsequently initiated a safety review of Octagam, concluding on 24 September that its licence should be suspended throughout Europe.

Healthcare professionals are advised to:

  • stop using Octagam and switch patients to the most appropriate alternative
  • be extra vigilant for signs of a thromboembolic event in patients who have very recently received Octagam
  • report any suspected thromboembolic events that have occurred in association with Octagam

The increase in thromboembolic events is thought to be related to problems with the medicine’s manufacturing process.

Octagam was licensed for use in various primary and secondary immunodeficiency states, idiopathic thrombocytopenic purpura, and certain inflammatory diseases such as Kawasaki syndrome and Guillain-Barré syndrome.

Further information can be found on the MHRA website.

Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register
Already registered?
Sign in

Register or Subscribe to MIMS

GPs can get MIMS print & online and GPonline for free when they register online – take 2 minutes, and make sure you get your free MIMS access! If you're not a GP, you can subscribe to MIMS for full access.

Register or subscribe

MIMS Dermatology

Read the latest issue online exclusively on MIMS Learning.

Read MIMS Dermatology

MIMS Adviser

Especially created for prescribing influencers.

Request free copy

Mobile apps

MIMS: access the full drug database and quick-reference tables on the go

MIMS Diagnosis and Management: concise information on signs and symptoms, investigations and diseases