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Translation of a-t 2019; 50: 86


Once again a warning about the adrenaline auto-injector EMERADE

In early October 2019, Bausch + Lomb issued a warning about a new "activation error" when using EMERADE pre-filled pens (1) that are authorised for the emergency treatment of severe acute allergic reactions (2). Some patients were not able to activate their adrenaline injectors (1). Back in June 2018 the company communicated the fact that "in very rare cases" a blockage of the pen had occurred but only during the stability test (3). This defect was reported as remedied by the co-distributor Dr. Mann only one day before the publication of the new "Dear Doctor Letter" and at the same time the affected batches were recalled from the market (4). Patients need to continue to carry two pre-filled pens with them at all times due to the new activation problems (1). Since the Summary of Product Characteristics (SPC) recommends prescribing two auto-injectors regardless of this fact so a second dose can be injected 5 to 15 minutes after the first if the patient fails to make a clinical improvement or even worsens, there continues to be the problem that this additional auto-injector is not available if the second pen is needed to administer the first dose (see also a-t 2018; 49: 70-1). The frequency of the new faults occurring is unclear. It results in the needle not being able to be released from the device when the normal activation force is applied. This can be seen in the fact that the needle protector does not extend. According to the recommendations issued by Bausch + Lomb, patients should first make two further attempts to administer the injection before using a second pen (1). We feel that this approach is unacceptable in an emergency situation. In light of the high prices, reliably functioning equipment should be expected. Unlike in Germany, the French provider of EMERADE decided to stop production until the problems have been resolved (5). The injectors JEXT and FASTJEKT are currently available as alternatives on the German market, but malfunctions have also been reported for these in the past (a-t 2017; 48: 40).

1Bausch + Lomb: "Dear Doctor Letter", as at 2 Oct. 2019; http://www.a-turl.de/?k=rdma
2Bausch + Lomb: EMERADE SPC, as at Sept. 2018
3Bausch + Lomb: "Dear Doctor Letter", as at 25 June 2018; http://www.a-turl.de/?k=tauc
4Drug Commission of German Pharmacists (AMK): 40/19 batch recall, 1 Oct. 2019; http://www.a-turl.de/?k=anub (registration required)
5ANSM: Communication of 23 Sept. 2019; http://www.a-turl.de/?k=harl

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