Safety Notices

From time to time notices relating to the safety and/or quality of medicinal products are published by the Health Products Regulatory Authority

These notices are classified under several priority related categories and may relate to human and veterinary medicines, or medical devices.   

The issues covered by these notices will range from quality defect information and medicinal product safety information through to updated information on the appropriate usage of medicines or devices.

Notices are categorised in accordance with their importance at time of publication.

The four notice categories are outlined as follows:

  • Advisory  -  Routine safety information            
  • Warning  -  Urgent safety information
  • Recall  -  Urgent safety information relating to a product recall
  • Publications  -  General safety information provided by the HPRA for publication via 3rd parties e.g. MIMS

The HPRA Drug Safety Newsletter is also published on a regular basis.

Date Title Type
12/02/2016 Updated recommendations to minimmise the risk of the rare brain infection PML with Tysabri. New advice may help early detection of PML and improve patients' outcomes 3rd Party Publications
12/02/2016 PRAC recommends that fusafungine nose and mouth sprays are no longer marketed. Committee had concerns over serious allergic reactions and limited evidence of benefit 3rd Party Publications
08/02/2016 UK recall of three products containing St. John’s Wort Warning
04/02/2016 Tachosil (human fibrinogen/human thrombin) - Important Safety Information from Takeda UK Ltd. as approved by the HPRA 3rd Party Publications
04/02/2016 Kineret (anakinra) - Importnat Safety Information from Swedish Orphan Biovitrum Ltd. as approved by the HPRA 3rd Party Publications
18/01/2016 HPRA MIMS Article January 2016 Bisphosphonates Small risk of osteonecrosis of the external auditory canal 3rd Party Publications
15/01/2016 Tarceva (erlotinib) - Important Safety Information from Roche Products (Ireland) Ltd. as approved by the HPRA 3rd Party Publications
06/01/2016 Gilenya (fingolimod) - Important Safety Information from Novartis Ireland Ltd. as approved by the HPRA (January 2016) 3rd Party Publications
05/01/2016 Viekirax (ombitasvir, paritaprevir, ritonavir) with or without Exviera (dasubuvir) - Important Safety Information from AbbVie Ltd. as approved by the HPRA 3rd Party Publications
22/12/2015 HPRA MIMS Article December 2015 Adverse Reaction Reporting during 2014 3rd Party Publications