Recall of emergency agent Jext for allergy sufferers

Danger to life: medication supervision calls „Adrenaline auto-injector Jext“ back

12/11/2013

Urgent warning of an allergy drug: The pharmaceutical company „ALK-Abelló Arzneimittel GmbH“ from Hamburg calls precautionary five batches of the allergy emergency agent „Adrenaline auto-injector Jext“ back. This was announced on Monday by the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn. Quality control by the manufacturer has revealed that the affected pens may not function properly and patients may not be able to adequately treat a life-threatening shock.

Five batches of the allergy emergency agent affected
As announced by the Federal Institute for Drugs and Medical Devices (BfArM) on Monday, the Hamburg pharmaceutical company calls „ALK-Abelló Arzneimittel GmbH“ (ALK) as a precaution five batches of the allergy emergency agent „Adrenaline auto-injector Jext®“ back. The agent is a one-time use „Adrenaline pen“, which is used in case of a severe allergic reaction to insect bites or food. Specifically, according to the manufacturer, four Jext® 300 micrograms batches (lot numbers: 0000815814, 0000800191, 0000799410, 0000738773) and a Jext® 150 microgram lot (0000844768) are concerned. Overall, around 8500 pens are affected.

Adrenaline may not be delivered properly to the muscle
As the manufacturer reported, had an internal quality control revealed, „that in certain batches, a very small percentage (0.04%, corresponding to 4 out of 10,000 pens of the batches concerned) there is the possibility that the adrenaline will not be delivered correctly into the muscle when the auto-injector is triggered.“ As a result, there is a risk for allergy sufferers, in the event of a life-threatening shock, that they may not be able to treat them adequately, according to Maik Pommer's warning from the Federal Institute.

Swap affected pens urgently in the pharmacy
Accordingly, patients and physicians should check their pens on the basis of the batch numbers and immediately exchange the affected emergency funds in the pharmacy - the costs for the replacement pens would be assumed according to the manufacturer. Who on the other hand one „Adrenaline auto-injector Jext“ 300 micrograms or 150 micrograms not belonging to the corresponding batches, according to a message from ALK „carry with you as usual and use as needed.“ However, patients who have a possibly affected pen of the mentioned batches should, however, these „continue to carry for safety and if necessary apply until they have received the replacement pen in the pharmacy“, so continues the pharmaceutical company.

Also parallel imports of „Eurim Pharm“ and „Pharma Gerke“ affected
In addition to the mentioned means are according to the production also in the Jext® parallel imports of companies „Eurim Pharm“ and „Pharma Gerke“ Risks for patients can not be ruled out. Affected here are a number of products whose batch numbers can be accessed in detail on the company's website () or via the customer hotline (phone: 040-703845-0).

autoinjector „Anapen“ also recalled last year
But this is not the first recall of an allergy drug: just last year, the Federal Institute for Drugs and Medical Devices had called for the adrenaline auto-injector „Anapen“ to exchange for another medicine. Also with this allergy emergency drug, it had been found in some batches that the adrenaline solution may not be or was inadequately delivered, thereby increasing the risk for emergency patients. (No)