Show news: from last 30 days (default), 60 days, 90 days, last visit or all

Dexamethasone 4mg/mL injection changes

21st October 2014

Dexamethasone injection 4mg/mL (Organon) has been acquired by Aspen pharmaceuticals. They have reformulated the product and it now contains 3.8mg/mL dexamethasone, available as a 1mL vial, which requires storage in a fridge.

The other dexamethasone injectable formulations in the UK are 3.3mg/mL (Hameln and Hospira), available as 1mL glass ampoules and do not require refrigeration.

These changes have significant implications for prescribing, administration and storage, with potential further risks for confusion and error above those already ready present due to the different dexamethasone salts.

MHRA has highlighted the issues in the October 2014 Drug Safety Update and UKMI has produced a safety assessment report summarizing the changes, the differences between the products and the potential next steps.

MHRA Drug Safety Update

UKMI product safety assessment (4 November 2014 an updated version is now available click here)

Dexamethasone 3.8mg/mL SPC