Other safety alerts
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| Australia: EpiPen Jr: Safety advisory - conditional release of one batch to alleviate shortage |
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The Therapeutic Goods Administration (TGA) announces that the TGA is allowing one batch (batch number: 9KC652) to be supplied that has not met all the required quality specifications due to the critical nature of the ongoing EpiPen Jr shortage.
Several batches of Epipen Jr have been found to be affected by very low-level contamination with another medicine, pralidoxime. This was caused by a manufacturing issue between production batches of different products. 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.
EpiPen Jr adrenaline autoinjectors are used for the emergency treatment of anaphylaxis in children and 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 release of the affected batch 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 Jan 2020. The most up-to-date information about the current EpiPen Jr shortage is available on the Medicine Shortages Information Initiative (MSII) website. The information on the MSII webpage is provided by sponsors and may be updated by a sponsor at any time.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/epipen-jr
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Monday, Dec 2, 2019
Issued at HKT 12:30
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