Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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407. To ask the Minister for Health if his attention has been drawn to the fact that the Health Products Regulatory Authority supports on its website an information leaflet on the medicine fluoxetine (details supplied); if this explanation of thoughts of self-harm or suicide when starting an antidepressant as being due to a delay in onset of action is an evidence based one; if it is contradicted by placebo controlled randomised clinical trials; and if he will make a statement on the matter. [22948/17]

Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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408. To ask the Minister for Health if his attention has been drawn to the fact that the Health Products Regulatory Authority supports on its website an information leaflet on the medicine fluoxetine which includes with regard to the way fluoxetine works the statement that (details supplied); if this is evidence based information supported by expert mental health professionals; and if he will make a statement on the matter. [22949/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 407 and 408 together.

The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines in Ireland. The HPRA highlights the fact that all medicines have some risks and a small number of people may develop side effects (also known as adverse reactions). The clinician treating the patient balances the risks associated with a medicine in the context of the overall benefit of the medicine to the health of the patient and the condition being treated.

The packaging of all medicines placed on the market must include a Summary of Product Characteristics (SmPC) leaflet, which sets out detailed product information intended for healthcare professionals. This information is regularly updated as new data becomes available through various sources of post-marketing experience, including further studies, literature reviews, and evaluation of adverse reaction data. The product information for authorised medicines is based on information submitted in the application dossier supplied by the company marketing the medicine. The application is reviewed by experts assessing the dossier, and the product information is updated as appropriate, to reflect the outcome of that assessment.

All medicines are also supplied with a packaging leaflet intended for the information of the patient/consumer. As the package leaflet is the part of the product information that is intended for patients, it uses patient-accessible language. Product labels and package leaflets play an essential part in the safe and effective use of the medicine by both patient and healthcare professionals.

Fluoxetine is a selective serotonin reuptake inhibitor. Serotonin is a neurotransmitter chemical in the brain. The mechanism of action is not fully elucidated, but fluoxetine is thought to work by enhancing the availability and activity of serotonin.

The HPRA, in conjunction with European counterparts, continues to review the safety of authorised medicines and takes appropriate regulatory action when necessary.