Further reports of problems with ANAPEN injectors
Having first heard reports of potential problems with ANAPEN injectors in the UK last May, EFA has received news of further concerns, this time from France. EFA’s French member, Association Française pour la Prévention des Allergies (AFPRAL), has said the French drugs agency, Agence nationale de sécurité du médicament et des produits de santé (ANSM), has received reports of defects in the product, and that the speed and delivery of adrenaline by ANAPEN injectors – a type of injector used to deliver adrenaline to people suffering from allergic anaphylactic shock – may not always be sufficient.
ANSM has issued a warning that all ANAPEN packages should include two injectors, in order to avoid situations in one adrenaline injector does not function correctly and no alternative is available. AFPRAL are very concerned about the situation, and have written to the French Health Minister regarding the situation.
Since reports emerged from the UK in May, EFA’s Food Allergy Working Group has been working on preparing a brochure on the case. We will continue to update you on developments on our website and in future ezines.
EMA starts safety review of medicines for COPD and asthma
The European Medicines Agency (EMA) has started safety reviews for two types of medicines in EFA’s disease area: almitrine-containing medicines (see here) – which are taken by mouth to treat lower-than-normal oxygen levels in the blood in chronic respiratory diseases – and short-acting beta-agonists (see here), widely used in Europe to treat asthma and cases of breathing difficulty, usually taken by inhalation using an inhaler device.
Almitrine, which has been authorised in some EU Member States since 1982, is being investigated because of concerns that it may lead to side effects including marked weight loss and peripheral neuropathy (nerve damage in the hands and feet) in some patients. Short-acting beta-agonists – which, aside from being used for asthma, are used in higher doses in cases of premature labour to suppress labour contractions – are being investigated because of concerns that higher doses can lead to a risk of cardiovascular side effects.
Both reviews will be carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA Committee responsible for the evaluation of safety issues for human medicines. It will make a set of recommendations to be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which is a regulatory body that represents national medicines regulatory authorities of the EU Member States. This will result in harmonised measures to be implemented in all Member States. EFA will keep you informed of developments.