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
06/10/2008 Adverse reaction reporting to the IMB for 2007 - Update - MIMS Publication 3rd Party Publications
03/10/2008 Perfalgan (paracetamol)-Important Safety Notice from Bristol-Myers Squibb regarding hepatic toxicity 3rd Party Publications
30/09/2008 Arcoxia (etoricoxib)-Important Safety Information from Merck Sharp & Dohme following approval by the Irish Medicines Board 3rd Party Publications
22/09/2008 Li Da Dai Dai Hua Capsules Warning
22/09/2008 Relistor (methylnaltrexone bromide)-Important Safety Information from Wyeth as approved by the Arcoxia (etoricoxib)-Important Safety Information from Merck Sharp & Dohme following approval by the Irish Medicines Board 3rd Party Publications
19/09/2008 Antidepressants–Update on suicidal thoughts and behaviour - MIMS Publication 3rd Party Publications
28/08/2008 Adverse Reaction & Quality Defect Reporting - MIMS Publication 3rd Party Publications
18/08/2008 Tysabri (natalizumab)-Important Safety Information from Elan/Biogen Idec as approved by the Arcoxia (etoricoxib)-Important Safety Information from Merck Sharp & Dohme following approval by the Irish Medicines Board 3rd Party Publications
08/08/2008 IMB Statement on Atorvastatin and Fusidic Acid Advisory
01/08/2008 EMEA recommends restricted use of oral norfloxacin-containing medicines in urinary infections Advisory