HPRA – Safety update

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) recently advised that healthcare professionals and patients be informed of recent product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)) changes in relation to the immunosuppressive effect of fingolimod and to reiterate some important recommendations for use.

Several new high-strength insulin products have been approved for use throughout the EU since 2013*.

The Health Products Regulatory Authority (HPRA) would like to remind healthcare professionals of the need for vigilance when prescribing, dispensing and/or counselling patients in relation to methotrexate.

Non-steroidal anti-inflammatory drugs (NSAIDs) are valuable therapeutic agents in the treatment of pain and inflammation and the risk-benefit profile of these medicines has been closely monitored nationally and at EU level.

In December 2015, the HPRA commenced publication of approved educational materials and tools for medicines on its website (www.

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the available evidence regarding the risk of osteonecrosis of the external auditory canal in patients taking bisphosphonates including data from the published literature and individual case reports.

The HPRA continues to place great emphasis on encouraging and promoting the submission of adverse reaction reports associated with the use of medicines from its stakeholders.

Thalidomide is licensed for use across the EU since 2008, in combination with melphalan and prednisone as first-line treatment for patients with untreated multiple myeloma who are aged 65 years or older, or those who are ineligible for high-dose chemotherapy.

Donepezil* is a specific and reversible inhibitor of acetylcholinesterase which has been authorised in Ireland since 1997 for use for the symptomatic treatment of mild to moderately severe Alzheimer’s dementia.

SGLT2 inhibitors include canagliflozin, dapagliflozin and empagliflozin alone or in combination with metformin, which are authorised for the treatment of type 2 diabetes mellitus.