Allergy sufferers warned as 2,300 lifesaving pens recalled
Published 01/03/2014 | 02:30
MORE than 2,300 life-saving injection pens, used by allergy sufferers to stop them going into lethal toxic shock, have been recalled by the Irish Medicines Board (IMB).
The Jext pen is used in emergencies to stop someone with a severe allergic reaction going into anaphylactic shock and dying.
The IMB has recalled several batches of the pen – totalling 2,368 pens – because of a potential quality defect which could lead to injection failure.
Fourteen-year-old Emma Sloan died recently on the street in Dublin City Centre after an allergic reaction to peanuts. Her mother was refused an emergency adrenaline pen injector by a pharmacy because she did not have a prescription.
Emma's death prompted Health Minister James Reilly to look at ways of making adrenaline pen injectors more available.
John Lynch, Director of Compliance at the IMB, said that while the defect could affect a very small number of pens, the IMB had not received any reports from patients or the medical profession in Ireland of any such failures.
"This recall is precautionary in nature," he said.
He urged patients who normally carried such pens to "adhere to current medical advice that they carry two pens at all times".
In all, seven lots of Jext pens have been recalled and users are asked to exchange the affected pens at their pharmacy or clinic.
About 5pc of adults and 3pc of children in this country have severe food allergies. Of 689 people admitted to hospital in 2012 for anaphylaxis, more than half were under 17. The numbers do not include those treated at home or by their GP.
The most common causes of anaphylactic shock are peanuts, tree nuts like almonds, walnuts, cashews, brazil nuts and sesame seeds, along with fish, shellfish, dairy products, eggs and soya, wasp or bee stings, natural latex (rubber), penicillin and other drugs.
The recall affects certain batches of Jext 150mcg (Junior) Solution for Injection and Jext 300mcg Solution for Injection both in pre-filled pens.
Manufacturer ALK-Abello estimates that the difficulty applies to an average of one in every 2,500 pens per batch.
The IMB says it has been working with ALK-Abello to procure replacement stock. Full details of the affected batch numbers are listed on the IMB website at www.imb.ie