Published: 19 December 2019
Safety Information
Alert Communication
EpiPen® Jr 150 mcg Adrenaline (epinephrine) Auto-Injector containing trace levels of Pralidoxime
19 December 2019
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.
EpiPen Jr 150 mcg batch 9KC652 did not meet the release limit for unknown impurities. Pralidoxime was identified as being present in the product, at a very low level. Pralidoxime is used to treat people who have been poisoned by pest-control chemicals and is a medicine with a safety profile that is well established. Medsafe has evaluated the safety, quality, and efficacy of this batch and has accepted that it may be supplied as the trace level of pralidoxime is of a very low risk for patients.
All other batches met all release specifications.
Advice for consumers and caregivers
Information for healthcare professionals
Products affected
Further information
Useful links
Advice for consumers and caregivers
If EpiPen Jr is needed to treat anaphylaxis, it should be used.
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.
The risk associated with this impurity is very low. It is very unlikely and unexpected that presence of pralidoxime at the low level identified would be associated with adverse effects.
Medsafe cannot give advice about an individual’s medical condition. If you have any concerns about a medicine you are taking, you are encouraged to talk to your healthcare professional.
Information for healthcare professionals
Adrenaline (epinephrine) auto-injectors are medically essential products since they are used in life-threatening allergic reactions (Type I) including anaphylaxis.
Testing of the batch to be supplied indicates that each pen would contain less than 1 microgram (mcg) pralidoxime. The maximum amount of pralidoxime detected in the EpiPen Jr products is less than 0.1% of the recommended therapeutic dose indicated for organophosphate poisoning in children and is not expected to cause adverse effects. While not expected to occur, known potential side effects of pralidoxime include dizziness, blurred vision, double vision, impaired ability to focus when looking from near to far objects, headache, drowsiness, nausea, rapid heart rate, rapid breathing and muscular weakness.
A 'Dear Healthcare Professional' letter, with content approved by Medsafe, will be provided to New Zealand pharmacies and medical practitioners.
The affected batch, 9KC652, is expected to be released to market in New Zealand in December 2019. There are no other batches available. The global supply of this product is very limited.
Adrenaline remains available in an ampoule presentation. Refer to the PHARMAC schedule for products which are available and funded. This is not affected by the issue described above.
All adverse events should still be reported using the link below.
| Product name | Sponsor |
|---|---|
|
EpiPen Jr Solution for Injection, 0.15 mg/0.3mL (150 mcg) Batch 9KC652 |
Mylan New Zealand Ltd |
Further information
EpiPen Jr 150mcg contain adrenaline (epinephrine), a sympathomimetic catecholamine indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis.
Pralidoxime is used to treat people who have been poisoned by pest-control chemicals and its safety profile has been well established in humans.
There is no specific literature on chemical interaction of adrenaline (epinephrine) with pralidoxime or drug interactions between them. The potential risk to patients arising from the above issue is considered to be low.
Based on the information and the low risk of the impurity in regard to patient safety, Medsafe is satisfied that the product meets the required standards for safety and efficacy.
The Australian Therapeutic Goods Administration (TGA) have also approved the supply of this batch of EpiPen® Jr 150 mcg Adrenaline to the Australian market.
Useful links
