Medsafe is reassuring patients and health care professionals that the current batch of EpiPen JR, which is being released to the market, is safe and effective.
Mylan, which supplies the adrenaline auto-injector, has reported to Medsafe an issue with the manufacturing process of batch 9KC652, which is expected to be distributed to New Zealand pharmacies shortly.
Medsafe recommends that the benefits of using this medicine outweigh its risks.
Medsafe has issued an alert communication relating to this batch.
The actions taken by Medsafe are consistent with those taken by the Australian Therapeutic Goods Administration (TGA).
EpiPen is used for the immediate treatment of a severe allergic reaction.
The manufacturing site, which is based in the US and owned by Pfizer, has identified that EpiPens in batch 9KC652 are likely to contain traces of the medicine pralidoxime, which is used to treat people who may have been poisoned by pest-control chemicals. Pralidoxime is a medicine with a safety profile that is well established.
‘We have evaluated the safety, quality, and efficacy of this batch, and taken the decision to allow its distribution to address the current shortage of EipPen Jr 150 mcg in New Zealand. There is currently a global shortage of this product,’ says Medsafe’s Group Manager Chris James.
‘It’s incredibly important to stress that the traces of pralidoxime are well below the recommended therapeutic dose of this medicine. We have assessed the risk relating to this is very low risk to patients.
‘We realise some patients will have little choice but to purchase an EpiPen from this batch. We want to reassure people that the risk associated with this batch is very low and that the benefits of having the EpiPen far outweigh the risk associated with the very small quantity of pralidoxime which may be present in the product.’
‘Mylan and the manufacturing site have provided detailed evidence that they’ve corrected the manufacturing issue and that future batches will not be affected by this issue.
‘We are working with Mylan to ensure health care professionals, including pharmacists, are aware of the issue relating to this batch. Mylan will be sending a letter to health care professionals prior to release of the batch in New Zealand.
‘If people do purchase an EpiPen from this batch, they should be reassured that it is effective and safe to use. If you are concerned please talk to your pharmacist or other health care professional. Over the holiday period, Healthline on 0800 611 116 will also have the information you need.’
About the EpiPen
EpiPen is only to be used for the immediate emergency treatment of a severe allergic reaction (also known as anaphylaxis). Your doctor or pharmacist will explain what this is like, so that you know when you must use EpiPen.
These reactions could be caused for example by food types, medicines, stinging insects, insect bites or latex.
The EpiPen has a shelf life of 24 months. EpiPens are single use.
Pralidoxime is used to treat people who have been poisoned by pest-control chemicals and its safety profile has been well established in humans.
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.