The Pharmacovigilance Office of the Italian Medicine Agency (AIFA) required all pharmaceutical companies to check that a warning regarding the presence of latex rubber in the primary packaging material or in medical devices supplied with some medicines is duly reported in the PIL of medicinal products.
The warning, provided for by the guideline Excipients in the label and package leaflet of medicinal products for human use, is the only way to protect patients suffering from allergies to latex. Italian hospitals have recently reported cases of latex-related anaphylactic shock and the AIFA pointed out that, although latex is not considered as an excipient, it is often contained in vials’ stoppers or in plungers of pre-filled syringes.
The warning states the following: “The container of this medicinal product contains latex rubber. May cause severe allergic reactions”.
In case such warning is not reported, the Company will have to submit a variation application to the Competent Authority as soon as possible, in any case no more than 30 days from the receipt of this communication, according to Regulation EC no. 1234/2008, in order to include this warning in the PIL.
