EpiPens used by millions of allergy sufferers have flaws, says coroner

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Dr Sean Cummings presided over Natasha Ednan-Laperouse


EpiPens routinely doled out by the NHS and used by millions of allergy sufferers across the world have potentially fatal flaws and are not fit for purpose, a coroner has said. 

Dr Sean Cummings, who presided over the inquest of Natasha Ednan-Laperouse who died of an allergic reaction after eating a Pret a Manger sandwich, has slammed the pens as ‘inherently unsafe’ because they are too short to reach muscle and don’t contain enough adrenaline.  

The 15-year-old passed away in a French hospital in 2016 despite being given two EpiPen injections from her father on a flight to Nice after eating a Pret sandwich that failed to fully list ingredients.  

In a damning report written after Natasha’s inquest, Dr Cummings has demanded answers from Epipen manufacturer Pfizer over the inadequate length of the needle and the dosage in the device. 

Around 250,000 people in the UK rely on auto-injectors, of which the most popular is EpiPen, manufactured by Pfizer. Figures show around 3.6 million prescriptions for EpiPens are dished out in the US each year. 

They are available on prescription in the UK and are thought to cost the NHS around £50 for a twin-pack – but the same product costs up to $700 (£531) in the US.

Dr Sean Cummings presided over Natasha Ednan-Laperouse's inquest, who died of an allergic reaction after eating a Pret a Manger sandwich

Dr Sean Cummings presided over Natasha Ednan-Laperouse’s inquest, who died of an allergic reaction after eating a Pret a Manger sandwich

Dr Sean Cummings slammed the pens as being 'inherently unsafe' because they are too short to reach muscle and don't contain enough adrenaline (stock EpiPen)

Dr Sean Cummings slammed the pens as being 'inherently unsafe' because they are too short to reach muscle and don't contain enough adrenaline (stock EpiPen)

Dr Sean Cummings slammed the pens as being ‘inherently unsafe’ because they are too short to reach muscle and don’t contain enough adrenaline (stock EpiPen)

Patients with allergies to foods such as peanuts are told to carry with them at all times in case they suffer a reaction.

In a damning report published after Natasha’s inquest, Dr Cummings warned: ‘The use of needles which access only subcutaneous tissue and not muscle is in my view inherently unsafe.’

The UK Resuscitation Council, a professional body established in 1983, states adrenaline injection needles should be at least 25mm, to ensure they reach muscle to allow it to work quicker. Patients often have to stab through thick clothing to administer the shot of adrenaline in an emergency. 

But for some adults, mainly those who are obese, the body recommends the needle of an auto-injector should be around 38mm. For toddlers, it should be at least 16mm.

HOW DO EPIPENS WORK? 

For countless allergy sufferers, an ‘auto-injector’ is a potential lifesaver.

These are spring-loaded syringes that give a shot of adrenaline to stop a severe allergic reaction known as anaphylactic shock.

This can cause a catastrophic drop in blood pressure and trigger a cardiac arrest, or the airways swell so much it can become hard to breathe. 

About 20 people in the UK die as a result each year.

Adrenaline is thought to halt this process – how is not quite clear – and those with severe allergies are prescribed an autoinjector such as an EpiPen (there is a variety of brands), loaded with epinephrine, also known as adrenaline, to carry at all times. 

In order to work quickly enough, the needle needs to get the adrenaline into the muscle below the fat layer directly under the skin. 

Once it’s in the muscle, the adrenaline gets into the bloodstream, taking effect within five minutes. 

EpiPens, which are distributed around the world by Pennsylvania-based firm Mylan, who own the rights to the product, have a 16mm-long needle. 

The UK Resuscitation Council, a professional body established in 1983, states adrenaline injection needles should be at least 25mm, to ensure they reach muscle to allow it to work quicker.

The body, headed by Professor Jonathan Wylie, also recommends that auto-injectors provide a dose of around 500 micrograms of adrenaline. But EpiPens contain only 300mcg.

EpiPens, which are distributed around the world by Pennsylvania-based firm Mylan, who own the rights to the product, have a 16mm-long needle.

The Resuscitation Council, headed by Professor Jonathan Wylie, also recommends that auto-injectors provide a dose of around 500 micrograms of adrenaline.

But Dr Cummings, in his report of Natasha’s death, highlighted that an EpiPen contains only 300mcg – compared to the 500mcg found in an Emerade auto-injector.

He added the combination of ‘an inadequate dose of adrenaline and an inadequate length needle raises serious safety concerns’, The Times reports.

Because of a global shortage of EpiPens, at least one patient in the UK has had to rely on an EpiPen Junior – the child’s version of the life-saving gadget. But they contain only 0.15mg of adrenaline – half the adult dose – and have a 13mm needle.

Mother-of-two Abby Doherty last month told Good Health that pharmacies had ran out of the adult EpiPen and it was only the EpiPen Junior available to her – despite official guidance that patients who are unable to get an EpiPen should ask for an alternative brand of auto-adrenaline injectors. 

The issues were previously raised in the inquest but now Dr Cummings has demanded answers from officials over his concerns about EpiPens.

Dr Cummings sent his report to Clive Schlee, chief executive of Pret-a-Manger, the Medicines and Healthcare Products Regulatory Agency (MHRA), the chief executive of Pfizer, and Michael Gove, secretary of state for Environment, Food and Rural Affairs. He gave them 56 days to respond. 

An MHRA spokesperson said: ‘Natasha’s death was a tragedy and our heart goes out to her family at this difficult time. Epipens have a good safety record and situations like this are incredibly rare.

‘Patient safety is our highest priority and our role, as regulator, is to make sure the medicines you and your family take are safe and effective.

‘As with all medicines, the safety of Epipens is carefully monitored and we will consider any recommendations we receive from the coroner, as well as other sources of information about Epipens, and act as needed to protect public health.’

A spokesperson for The Anaphylaxis Campaign said: ‘It is important to note that The European Medicines Agency (EMA) completed a review of all adrenaline auto-injectors approved in the EU in 2017 and concluded that manufactures should carry out studies in humans to fully understand when and how much adrenaline reaches the blood stream, and how quickly and effectively it acts on body tissues when given through an auto-injector. 

‘These studies have started and will help to inform future recommendations for adrenaline auto-injectors.’

Natasha begged her father to help her before collapsing on a British Airways flight to Nice. She fell ill within three minutes of consuming the baguette she bought at Pret’s Heathrow Terminal 5 branch.

She believed the sandwich, which contained artichoke, olive and tapenade, was safe to eat because sesame was not listed on the packaging.

But Natasha started complaining of an itchy throat before hives broke out on her neck and midriff 20 minutes after take-off. Her father then gave her two EpiPens in the plane’s toilet.

Natasha, who was flying with BA to Nice with her father and a friend, later suffered a cardiac arrest on board and died in a French hospital.

Dr Cumming’s claims come amid a global shortage of EpiPens, which are prescribed by doctors in the UK but can be purchased by online pharmacies for around £45.

There are no official figures on how many EpiPens remain in the UK – but many pharmacies have reported that they do not have any of the auto-injectors left.

The two other brands available in the UK, Jext and Emerade, are now also hard to find. Emerade’s adult version has a 24mm long needle and contains 500mcg of adrenaline. Jext’s adult version contains 300mcg and has a 16mm long needle – similar to an EpiPen.

Regulators last month certified the use of some out-of-date EpiPens in the UK.

Dr Cummings sent his report to Clive Schlee, chief executive of Pret-a-Manger, the Medicines and Healthcare Products Regulatory Agency (MHRA), the chief executive of Pfizer, and Michael Gove, secretary of state for Environment, Food and Rural Affairs

Dr Cummings sent his report to Clive Schlee, chief executive of Pret-a-Manger, the Medicines and Healthcare Products Regulatory Agency (MHRA), the chief executive of Pfizer, and Michael Gove, secretary of state for Environment, Food and Rural Affairs

Dr Cummings sent his report to Clive Schlee, chief executive of Pret-a-Manger, the Medicines and Healthcare Products Regulatory Agency (MHRA), the chief executive of Pfizer, and Michael Gove, secretary of state for Environment, Food and Rural Affairs

EpiPen and EpiPen Junior devices, supplied by Pennsylvania-based firm Mylan, have faced shortages in the UK, US and other countries for months

EpiPen and EpiPen Junior devices, supplied by Pennsylvania-based firm Mylan, have faced shortages in the UK, US and other countries for months

EpiPen and EpiPen Junior devices, supplied by Pennsylvania-based firm Mylan, have faced shortages in the UK, US and other countries for months

Children with severe allergies are not allowed to go to school without $700 EpiPen amid nationwide shortage of the life-saving drug 

Children with severe allergies across the US are being forced to stay home from school due to a nationwide EpiPen shortage.

Chiquita Morris said her five-year-old son Eden was sent home on his first day of kindergarten at Spanaway Elementary School in Spanaway, Washington.

She told KIRO 7 school officials told her that, due to her son’s severe allergies, he wouldn’t be able to attend class until he had an EpiPen on him.

For more than a year, Morris says she’s been trying to get her hands on the $700 injector, but with no luck.

But the school district argues there’s nothing it can do because state law requires children with ‘life-threatening condition’ to have the medication on file prior to attending school.

With as many as two students affected by this in every classroom in the US, parents are calling on schools to have back-up EpiPens – or generic versions – on hand until their pharmacies can fill prescriptions for them.

Chiquita Morris said her five-year-old son Eden was sent home on his first day of kindergarten at Spanaway Elementary School in Spanaway, Washington, because he didn't have an EpiPen on him for his severe allergies

Chiquita Morris said her five-year-old son Eden was sent home on his first day of kindergarten at Spanaway Elementary School in Spanaway, Washington, because he didn't have an EpiPen on him for his severe allergies

Chiquita Morris said her five-year-old son Eden was sent home on his first day of kindergarten at Spanaway Elementary School in Spanaway, Washington, because he didn’t have an EpiPen on him for his severe allergies

The MHRA said the shelf-life of some batches of adult-use EpiPens can be extended by four months. But it did not apply to EpiPen Junior versions.

ALKAbelló, the Danish company that manufactures rival device Jext, said it was ‘doing all we can to meet the increased demand’ when asked about the shortage earlier this year.

Cases of anaphylaxis have increased and so there is great demand for auto-injectors. According to NHS figures, 325,785 auto-injectors were prescribed in 2016, the most recent period for which figures are available.

The first indications of the global shortage came in April when Mylan warned of supply problems. The crucial devices are used by allergy patients during a deadly anaphylactic shock – which can kill in minutes.

Patients jab the needle into their thigh, giving them an immediate dose of adrenaline to temporarily stop symptoms and allow them enough time to reach hospital.

EpiPens, which are distributed around the world by Pennsylvania-based firm Mylan, who own the rights to the product, have a 16mm-long needle. Emerade, an alternative auto-injector, has a 24mm long needle

EpiPens, which are distributed around the world by Pennsylvania-based firm Mylan, who own the rights to the product, have a 16mm-long needle. Emerade, an alternative auto-injector, has a 24mm long needle

EpiPens, which are distributed around the world by Pennsylvania-based firm Mylan, who own the rights to the product, have a 16mm-long needle. Emerade, an alternative auto-injector, has a 24mm long needle

WHAT SHOULD YOU DO IF YOU CAN’T GET HOLD OF AN EPIPEN? ADVICE FROM EXPERTS IN THE UK 

  • Do not dispose of expired devices before receiving a new one. Remember, the four-month extension on expiry dates is advice from the Department of Health and Social Care/MHRA
  • Keep trying. Anyone who doesn’t have an auto-injector and can’t get one should call all the pharmacies in their area until they find one that still has stock. Getting one may involve travelling. Be quick – due to high demand, pharmacists won’t reserve auto-injectors.
  • One auto-injector is enough for most people, though those with more severe problems who carry two doses should continue to do so.
  • Take extra care to avoid allergens. Dr Pamela Ewan, consultant allergist at Addenbrooke’s Hospital in Cambridge, says: ‘Most allergic reactions can be treated with antihistamines.’
  • Small studies show that EpiPens can remain potent for years. Researchers in California found EpiPens that were 50 months out of date contained at least 90 per cent of the stated amount of the adrenaline. The drug does not become toxic.
  • Ask your child’s school to go nut-free. Dr Adrian Morris, an allergy doctor at the Surrey Allergy Clinic, says: ‘Otherwise, make sure your school knows about your child’s triggers and takes steps to minimise any contact during the school day.’
  • Schools may have a stock of EpiPens as they can buy them without prescription. If you can’t get one, write to your child’s teacher to see if there is one on site. 
  • If your child has severe allergies, and you cannot get an auto-injector then you could be justified in keeping them away from school. Dr Morris said: ‘Children may have to be kept at home and out of harm’s way.’
  • In extreme cases, Dr Morris suggests asking your doctor for ampoules of adrenaline and syringes. ‘The GP may need to prescribe the age- appropriate amounts and instruct the parent how to inject this into the child in a situation of anaphylaxis.’
  • Never try to make your own EpiPen, as some people are advocating online, says Dr Morris. ‘They can fail and it’s really not a safe and reliable option.’
  • If you’re travelling by air, the Anaphylaxis Campaign advises: ‘Stick to plain foods without sauces and dressings and take safe, non-perishable snacks with you. If you don’t know what’s in the food, don’t eat it.’ Some airlines have removed peanut snacks from flights, but you should carry wipes to clean surfaces on the aircraft to minimise the risk of skin contact with traces on seat-back trays and armrests.
  • In an emergency – whether or not you have an auto-injector – call 999 or go to your nearest accident & emergency department, says Dr Ewan.

Children with severe allergies across the US are being forced to stay home from school due to a nationwide EpiPen shortage, DailyMail.com reported yesterday.

Chiquita Morris said her five-year-old son Eden was sent home on his first day of kindergarten at Spanaway Elementary School in Spanaway, Washington.

School officials reportedly told her that, due to her son’s severe allergies, he wouldn’t be able to attend class until he had an EpiPen on him. 

Figures state there were around 3.6 million Americans who were prescribed an EpiPen in 2015, the Wall Street Journal reported.

In the US, EpiPens cost around $700 (£531). Mylan faced an outpouring of criticism after it raised the price of a pack of two in 2016. The same package cost $100 in 2008. 

Martin Shkreli – the ‘Pharma Bro’ who hiked the price of HIV medication Daraprim by 5,000 per cent – defended the firm two years ago.

Officials at the US Food and Drug Administration have previously blasted the firm for deaths and illnesses reported after using faulty products.

The agency said last September these deaths would have been preventable had the firm tested its products or investigated malfunctioning reports more thoroughly. 

The FDA granted approval to the first generic alternative for the EpiPen in August. It allowed Israel-based Teva Pharmaceuticals to market its auto-injector.

Australia has been struck repeatedly by the global supply issues over EpiPens, which are the only approved adrenaline jab in the country.

Health officials in Australia were forced to keep extending warnings of a nationwide shortage as patients were left fearing for their lives, it was reported in April.



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