Children with severe allergies who need to carry life-saving medication are being forced to rely on out-of-date EpiPens due to a global shortage of the adrenaline shots.
EpiPen and EpiPen Junior devices, which are supplied by Mylan and produced by Pfizer, have faced shortages in the UK and other countries for months. But the crisis has deepened with the Junior version now unavailable.
The latest stock shortages have led the medicines regulator to certify some batches of expired EpiPens as safe amid fears those with severe allergies who go into anaphylactic shock would be left with no alternative.
It was forced to extend the use-by-date of some EpiPens by four months after concerns were raised from users that their current shots were due to expire and they had been unable to get replacements. However, the extension does not apply to the Junior version.
A statement issued to healthcare providers on behalf of the Department of Health noted: “EpiPen and EpiPen Junior will be subject to limited availability for the remainder of 2018. Mylan are now out of stock of EpiPen Junior and interruptions in the supply are anticipated to continue for the coming months.”
More of the Junior devices are expected in stock in October, but it is not clear whether these will meet demand.
Manufacturing problems in the US have meant disruption for suppliers of EpiPens – the most common adrenaline auto-injectors (AAIs) are prescribed to those who suffer severe allergies such as to nuts, milk, fish, shellfish, eggs or some fruits.
Those affected are usually recommended to keep two AAIs with them at all times in case of a reaction. EpiPens can only be used once and have an expiry date of at least 12 months.
The standard device contains 300mcg of adrenaline. Smaller 150mcg Junior AAIs are issued to children who weigh 30kg (4st 10lb) or less.
Adults and older children are being advised they can use their devices up to four months beyond the listed expiry date in an attempt to maintain supply levels but the extension does not apply to the 150mcg devices for younger children.
A statement from the Department of Health and Social Care to healthcare providers said: “Mylan have obtained acceptance from the medicines and healthcare products regulatory agency (MHRA) to extend the use of specific batch numbers of EpiPen 300mcg auto-injectors beyond the labelled expiry date for four months.”
Last week an inquest heard that 15-year-old Natasha Ednan-Laperouse died on a flight after suffering a serious allergic reaction to a Pret A Manger baguette containing sesame seeds. This was despite her father injecting her with two EpiPen devices.
EpiPens make up three-quarters of the 340,000 adrenaline auto-injectors prescribed annually.
There are two other adrenaline auto-injector devices available in the UK: Emerade and Jext. Suppliers of both medicines are working to increase their supplies to the UK over the coming months.
The health department guidance said that if people were left with nothing but expired AAIs they should keep them – until they get replacements – and be prepared to use them.
While AAIs become less effective after their expiry date, they are not harmful, and it is better to use an expired AAI than none at all, it said.
It added that “careful management” of existing supplies would prevent the need for using expired pens.
The health minister, James O’Shaughnessy, said: “We are doing everything we can to ensure patients continue to access the medications they need and we have issued detailed guidance to healthcare professionals.
“Other brands of adrenaline auto-injectors are available in the UK and we are working closely with Mylan and Pfizer to find a solution to the problem as soon as possible. Any patient unable to obtain supplies of EpiPen should speak to their clinician about using an alternative brand.”
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