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Valproate (Epilim): New contraindications, strengthened warnings and measures to prevent exposure during pregnancy

Valproate-containing medicines (licensed in Ireland as Epilim) are now contraindicated in women of childbearing potential unless the terms of a special pregnancy prevention programme are followed. Valproate should not be used in female children and women of childbearing potential unless other treatments are ineffective or not tolerated. In 2014 the warnings and restrictions regarding the use of valproate in women ...

Xofigo (Radium-223 Dichloride) – Contraindicated in Combination with Abiraterone Acetate (Zytiga) and Prednisone/Prednisolone

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended a contraindication regarding use of Xofigo in combination with abiraterone acetate (Zytiga) and prednisone/prednisolone. This recommendation follows the review of preliminary data from an ongoing clinical trial which shows an increased risk of death and fractures. Pending conclusion of the review and to allow a thorough assessment of ...

Gabapentin – Respiratory Depression without Concomitant Opioid Use

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded a review in 2017 of respiratory depression associated with gabapentin use without concomitant opioid therapy. Gabapentin-containing medicinal products are licensed in Ireland under various brand names for the treatment of specific forms of epilepsy and also for the treatment of peripheral neuropathic pain. The risk of central ...

Domperidone-Containing Medicines: Reminder of the Risk of Cardiac Adverse Reactions-Restricted Indication, Contraindications and Reduced Dose and Duration of Use

In 2014 a European-wide review recommended restrictions on the use of domperidone-containing medicines following an evaluation of the benefits and risks of domperidone. This review was triggered due to concerns regarding cardiac adverse effects associated with domperidone use. After evaluation of available evidence on the efficacy and safety of domperidone from various sources (non-clinical and clinical, published and unpublished), the ...

Contraindication for Injectable Methylprednisolone Products Containing Lactose (Solu-Medrone 40mg/vial) in Patients with Cow’s Milk Allergy

Injectable methylprednisolone products containing lactose are authorised for use in a range of different indications including the treatment of symptoms of severe allergic reactions and other inflammatory conditions. In Ireland, Solu-Medrone Powder and Solvent for Solution for Injection or Concentrate for Solution for Infusion 40mg/vial is the only authorised injectable methylprednisolone-containing product formulated with lactose, and may contain trace amounts ...

Amoxicillin; Co-Amoxiclav – Very Rare Reports of DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recently completed a review of a signal of drug reaction with eosinophilia and systemic symptoms (DRESS) in association with amoxicillin and co-amoxiclav. It is already known that serious and occasionally fatal hypersensitivity reactions (including anaphylactoid reactions) have been reported in patients on penicillin therapy. Having considered the available evidence in ...

Educational Materials and Tools for Medicines Published on HPRA Website

Educational materials are additional risk minimisation measures that are intended to promote the safe and effective use of the medicinal product. While the approved product information (the Summary of Product Characteristics (SmPC), Package Leaflet (PL) and product labelling) provides all relevant information for medicinal products, educational materials focus on one or more specific safety concerns related to use of a ...

Quinine – Reminder of Safety Profile and Potential Drug-Drug Interactions Particularly Where Used for Nocturnal Leg Cramps

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recently concluded a routine periodic review of medicinal products containing the active substance quinine. In Ireland, medicinal products containing quinine are licensed as a sulphate salt for the treatment and prevention of nocturnal leg cramps in adults and the elderly (when cramps cause regular disruption of sleep). At higher doses, ...

New CPD e-Learning Module on Reporting Suspected Adverse Drug Reactions

A new free e-learning module has been created for all healthcare professionals to learn about the importance of reporting suspected adverse drug reactions (ADRs). This module was created as part of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action project. The module has received accreditation from the European Accreditation Council for CME (EACCME®). Doctors are awarded 1 ...

High-Strength Insulin Preparations

A number of high-strength insulin products have been approved for use throughout the EU since 2013*. High-strength insulin products contain a concentration of insulin which exceeds the standard 100 units/ml (e.g. they may contain 200 units/ml or 300 units/ml) and provides for a better dissolution profile over the duration of action, helping to  meet an increasing need for higher doses ...