Due to the critical nature of the ongoing EpiPen Jr shortage, the TGA has announced it is allowing one batch to be supplied that has not met all the required quality specifications
The conditional release applies to batch number 9KC652.
This batch is not yet available in Australia, but the TGA says it is working with the sponsor on details of its supply and will publish updated information as it becomes available.
Several batches of Epipen Jr have been found to be affected by very low-level contamination with pralidoxime.
This was caused by a manufacturing issue between production batches of different products, the TGA says, noting that the manufacturer has taken action to prevent the issue for future batches.
“Pralidoxime is used to treat people who have been poisoned by pest-control chemicals and its safety profile has been well established in humans,” it says.
“In the situations in which EpiPen Jr is used, administration of adrenaline can be life-saving. The risk from not having adrenaline available to treat anaphylaxis is far greater than the risk of being exposed to a very small amount of pralidoxime.”
EpiPen Jr supplies are currently critically constrained in Australia and other countries, the TGA warns.
“The release of the affected batch (no: 9KC652) will go some way towards meeting continuing patient demand.
“The current shortage of EpiPen Jr has been caused by this manufacturing issue and is currently expected to continue until 31 January 2020.”