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
23/09/2010 Rosiglitazone–containing Medicines (Avandia, Avandamet and Avaglim) – Important Safety Information issued by the Irish Medicines Board 3rd Party Publications
10/09/2010 EVICEL Solutions for Sealant (Human) products - Important Safety Information from Omrix Biopharmaceuticals Ltd. and Ethicon, Inc. as approved by the Irish Medicines Board 3rd Party Publications
07/09/2010 Rosiglitazone (Avandia/Avandamet) and Cardiovascular Risk 07.09.2010 3rd Party Publications
19/08/2010 Xyrem (sodium oxybate) - Important Safety Information from UCB (Pharma Ireland Ltd) as approved by the Irish Medicines Board 3rd Party Publications
12/08/2010 Urorec (Silodosin) - Important Safety Information from Recordati as approved by the Irish Medicines Board 3rd Party Publications
09/08/2010 Oruvail Gel and Orugesic Gel (Ketoprofen) - Important Safety Information from Sanofi Aventis as approved by the Irish Medicines Board 3rd Party Publications
09/08/2010 Ketoprofen - Important Safety Information from A.Menarini as approved by the Irish Medicines Board 3rd Party Publications
09/08/2010 Isotretinoin (Roaccutane) - Risk of serious skin conditions 3rd Party Publications
03/08/2010 Cardioxane (dexrazoxane) - Important Safety Information from Novartis as approved by the Irish Medicines Board 03.08.2010 3rd Party Publications
03/08/2010 SSRIs and SNRIs: Risk of Persistent Pulmonary Hypertension in the Newborn 3rd Party Publications