389. Deputy Gino Kenny asked the Minister for Health if his Department will consider replicating the FDA black box warning regarding cautionary use by persons under 18 years of age on antidepressants such as Prozac in the USA on the packaging of similar drugs here (details supplied); and if he will make a statement on the matter. (Question 17660/18 asked on 24 Apr 2018)
Minister for Health (Deputy Simon Harris): The legal framework for provision of detailed warnings for medicines across the EU is through the product information, which specifically provides for the format and content of these documents. The summary of product characteristics (SmPC) for the healthcare professional and the package leaflet (PL) for patients are reviewed and approved as an intrinsic part of the licensing of a medicine, and continuously updated to reflect the current state of knowledge of the medicine and the risks associated with its use. As such, it is considered important for healthcare professionals and patients/carers to regularly read and review these documents to support safe and appropriate use.
With regard specifically to Prozac, which is one of a group of antidepressant medicines known as SSRIs, it should be noted that the information included in the US ‘black box’ is entirely consistent with that provided in the approved product information for these medicines in the EU.