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
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
01/08/2008 Thalidomide Pharmion-Important Safety Information from Celgene as approved by the Irish Medicines Board 3rd Party Publications
01/08/2008 EMEA recommends restricting the use of oral moxifloxacin-containing medicines Advisory
28/07/2008 Dostinex (cabergoline)-Important Safety Information from Pfizer as approved by the Irish Medicines Board 3rd Party Publications