HPRA – Safety update

Apremilast is a selective immunosuppressant medicine indicated for use alone or in combination with disease modifying antirheumatic drugs (DMARDs) for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response, or who have been intolerant to DMARD therapy previously.

Direct-Acting Antivirals (Daklinza, Exviera, Harvoni, Olysio, Sovaldi, Victrelis, Viekirax, Zepatier and Epclusa)* are used to treat chronic hepatitis C virus (HCV) infection.

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) advised that healthcare professionals and patients be informed of 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*.

Implanon NXT 68mg is a radiopaque, non-biodegradable progestogen only flexible implant for subdermal use (containing the active substance etonogestrel), which is authorised in Ireland since 2010 for contraception.

The outcome of the Europe-wide review of valproate-containing medicines was communicated to healthcare professionals in December 2014 via the HPRA Drug Safety Newsletter (Edition 65) and a Direct Healthcare Professional Communication (DHPC) circulated by the Marketing Authorisation Holder (MAH) following approval by the HPRA.

Miconazole is known to enhance the anticoagulant effect of warfarin and reports of significant bleeding episodes associated with concomitant use of these medicines have been well documented in the literature and spontaneously notified to medicines agencies, including the HPRA.

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has completed an evaluation of the risk of diabetic ketoacidosis (DKA) associated with sodium-glucose co-transporter 2 (SGLT2) inhibitors.

Fusafungine-containing medicinal products (i.

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of the known risk of pneumonia associated with inhaled corticosteroid (ICS) medicines when used to treat COPD.