Safety Notices

From time to time notices relating to the safety, efficacy and quality of human medicinal products are published by the Health Products Regulatory Authority.

The issues covered by these notices include medicinal product safety information, updated efficacy information on the appropriate usage of medicines and quality defect information.

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 information provided by 3rd parties as approved by the HPRA, e.g. MIMS, Direct Healthcare Professional Letter or Product Information Update

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

Date Title Type
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
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
08/01/2016 Product Information Update- Decapeptyl 3-month, 11.25 mg Powder and solvent for suspension for injection (Triptorelin) 3rd Party Publications