Recall of emergency equipment "Jext" for allergy sufferers



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Danger to life: Drug supervision calls “Adrenaline auto-injector Jext” back
12.11.2013

Urgent warning of an allergy medication: As a precaution, the pharmaceutical company "ALK-Abelló Arzneimittel GmbH" from Hamburg is recalling five batches of the allergy emergency medication "Adrenaline Auto Injector Jext". This was announced on Monday by the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn. A quality control of the manufacturer had shown that the affected pens may not work properly and that patients might not be able to treat life-threatening shock adequately.

Five batches of the allergy-related emergency aid affected As the Federal Institute for Drugs and Medical Devices (BfArM) announced on Monday, the Hamburg-based pharmaceutical company "ALK-Abelló Arzneimittel GmbH" (ALK) is calling for precautionary five batches of the allergy-related emergency aid "Adrenaline auto injector Jext®" back. The remedy is a single-use "adrenaline pen", which is used in the event of a severe allergic reaction to insect bites or food. Specifically, according to the manufacturer, there are four batches of Jext® 300 microgram (batch numbers: 0000815814, 0000800191, 0000799410, 0000738773) and one batch of Jext® 150 microgram (0000844768). A total of around 8,500 pens are affected.

Adrenaline may not be released correctly into the muscle As the manufacturer reports, an internal quality control had shown that “in certain batches, there is a very small percentage (0.04%, corresponding to 4 out of 10,000 pens of the affected batches) that the adrenaline is not released into the muscle correctly when the auto-injector is triggered. "This means that allergy sufferers run the risk of not being able to treat this in a sufficient manner in the event of a life-threatening shock," warned Maik Pommer from the Federal Institute.

Exchange affected pens urgently in the pharmacy Accordingly, patients and doctors should check their pens using the batch numbers and exchange affected emergency equipment immediately in the pharmacy - the costs for the replacement pens would be assumed according to the manufacturer. On the other hand, if you have a 300 microgram or 150 microgram “adrenaline auto-injector Jext” that does not belong to the appropriate batches, you can carry it with you as usual, and use it as needed, according to ALK, including patients with a pen that may be affected of the batches mentioned, but should “keep them with them for safety and use them if necessary until they have received the replacement pen in the pharmacy,” the pharmaceutical company continues.

Parallel imports also affected by "Eurim Pharm" and "Pharma Gerke" In addition to the funds mentioned, according to the manufacturer, risks for patients cannot be ruled out for the Jext® parallel imports of the companies "Eurim Pharm" and "Pharma Gerke". This affects a whole range of products, the batch numbers of which can be called up in detail on the company's website () or via the customer hotline (telephone: 040-703845-0).

“Anapen” auto-injector also recalled last year But this is not the first recall of an allergy medication: only last year the Federal Institute for Drugs and Medical Devices asked to replace the “Anapen” adrenaline auto-injector with another drug. With this emergency allergy medication, too, it had been found in some batches that the adrenaline solution may not have been or was insufficiently delivered, and there was therefore an increased risk for emergency patients. (No)

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