On 2nd December the French Health Authority, l’Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), announced its decision to temporarily suspend all medicinal products produced and distributed by the French pharmaceutical company Stallergenes.
All immunotherapy treatments (APSI – Allergènes Préparés Spécialement pour un Individu) that had been distributed by Stallergens after the 13th of August 2015 have been recalled from the market. APSI’s are specific allergenic extract preparations prepared for individuals as part of immunotherapy treatement (APSI in France: Allergènes préparés pour un seul individu / Allergens prepared for a single individual).
In France patients and healthcare professionals who have questions can contact Stallergenes’ call centre at the following toll free numbers:
Patient: +33 0800 940 390
Healthcare professional: +33 0800 940 377
Stallergenes is informing healthcare professionals prescribing its products in all concerned countries about this product recall. We do not yet have information on the specific countries, or numbers of patients affected by this recall.
The company is also contacting patients who started an immunotherapy treatment after the 13th of August. They have been instructed to stop their medication, and to return the medicines to Stallergenes. They have also been advised to contact their doctors in order to discuss and amend their treatment.
The French Health Authority has advised that, as allergy immunotherapy is a disease modifying treatment with mid to long term effects, the treatment interruption resulting from the product recall is unlikely to present a risk for patient’s health.
The decision to recall the products follows from issues related to the establishment of a new IT system at the plant. This new system caused some errors in the provision of information to patients (labelling and dosage errors).
Once again it is important to note that temporarily stopping immunotherapy treatment will not entail serious health risks for patients. However if you have any concerns or queries please don’t hesitate to contact your healthcare professional or the toll free information number for patients set up by the company (see above).