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
21/03/2016 SGLT2 inhibitors - Important Safety Information from Janssen-Cilag Limited, AstraZeneca Limited and Boehringer Ingelheim Limited as approved by the HPRA 3rd Party Publications
15/03/2016 Xofigo (radium-223 chloride) - Important Safety Information from Bayer Ltd. as approved by the HPRA 3rd Party Publications
15/03/2016 Tysabri (natalizumab) - Important Safety Information from Biogen Idec (Ireland) Ltd. as approved by the HPRA 3rd Party Publications
02/03/2016 Intrauterine contraceptives: Levonorgestrel Intrauterine Delivery Systems - Mirena and Jaydess - Important Safety Information from Bayer Ltd. as approved by the HPRA 3rd Party Publications
19/02/2016 HPRA MIMS Article February 2016 HPRA commences publication of educational materials and tools for medicines 3rd Party Publications
12/02/2016 SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis. Healthcare professionals should be aware of atypical cases 3rd Party Publications
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