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Dr Gérald Kierzek (Medical Director)
Due to a risk of malfunction, Emerade adrenaline auto-injectors have not been temporarily distributed in pharmacies since May 4. Consequently, the other references are experiencing a tension in their supply, alerts the Medicines Safety Agency. A situation that can quickly become problematic.
Vigilance if you have to carry an anti-anaphylactic shock pen with you. According to an alert from the National Medicines Health Agency, the temporary global halt in the distribution of Emerade pens is currently causing supply tensions on all other adrenaline auto-injectors (Anapen, Epipen and Jext).
A precautionary shutdown of the Emerade pen
Why such a stop? Because the Bausch laboratory, which markets the Emerade treatment, has identified a defect in its device: during a drop test (ISO 11608-5 standard) the number of auto-injectors no longer activating or triggering prematurely was slightly higher than the norm… The risk of malfunction is however low:
“Since the marketing in France in 2021 of these Emerade auto-injectors, we have not received any report in connection with this risk” indicates the ANSM.
Given the low risk of dysfunction and to prevent patients from going without adrenaline, healthcare professionals and patient associations have agreed to do not recall Emerade auto-injectors already in possession patients. However, their absence from pharmacies reflects on other adrenaline auto-injectors (Anapen, Epipen and Jext), which can be rare.
“These are vital pens, a break would be dramatic”
Dr Gérald Kierzek, emergency doctor and medical director of Doctissimo, explains to us why this brief announcement is essential for those concerned:
“These are vital pens for people who have already experienced severe allergic shock, which is called anaphylactic shock (Quick’s oedema, etc.). They are prescribed by specialists, allergists, and must always be available to patients. While we tell them to always have them on them in case of travel, vacation (because a recurrence is always possible) and that everything is done today to promote the practical side, a shortage of stock can be dramatic ” .
The emergency doctor also reminds that if there is no adrenaline pen nearby, the person who feels the first signs of an allergic shock or who knows he is exposed to allergens which are prohibited to him, must immediately do call 15.
Faced with the situation, clear recommendations
To avoid increasing the tension and remain well protected against allergic shock, the ANSM shares a series of recommendations to those concerned:
- Do not have their auto-injectors replaced before the expiry date. During their next medical consultation, the doctor will prescribe an auto-injector of a brand other than Emerade;
- Always carry both auto-injectors with them;
- Keep them well in the box provided in order to protect them;
- In the event of a problem with the functioning of an auto-injector, use the 2e auto-injector and then report the one that didn’t work to a pharmacist or their doctor and report it on signalement.social-sante.gouv.fr .
Physicians are called upon to no longer prescribe Emerade auto-injectors due to the temporary discontinuation of distribution and to prescribe an auto-injector of another brand only on the expiry date of Emerade auto-injectors.
The intranasal EpiPen, the solution of tomorrow?
To simplify the intake of adrenaline against anaphylaxis, a nasal spray by the name of Neffy could well be marketed soon. Although the idea has been under consideration for several years, an external advisory committee of the Food and Drug Administration (FDA) in the United States, recently voted in favor of the product. As effective as “pens” seem, the nasal spray dispenses a fine mist of epinephrine solution into the nasal cavity, quickly absorbed through the moist lining of the nasal passages. From there, epinephrine enters the bloodstream, where it binds to specific cell receptors to improve blood flow and reverse the symptoms of a severe allergic reaction. According to the studies carried out, its time of action and its result would be similar to that of injections. Also with the advantage of being more accessible and less invasive, for people who fear needles.
“Going to an EpiPen, but intranasal would be a real advantage. Because to be effective, an emergency drug must always be easier to access and use. A spray option would therefore be ideal” reacts Dr. Kiezek.
The FDA’s final decision is expected by mid-2023.