A number of medicines used to treat blood pressure and heart conditions are being recalled.
The action follows the identification of an impurity identified in the valsartan ingredient manufactured at a plant in China.
The Health Products Regulatory Authority (HPRA) says patients should not stop taking medicines containing valsartan but should go to their pharmacist or doctor immediately to discuss treatment.
The impurity that was found is a probable carcinogen but there Is no evidence that it has caused any harm.
The HPRA says not all valsartan medicines are affected and is reassuring patients that other treatments are available.
@TheHPRA is undertaking a precautionary recall of some #valsartan blood pressure and heart medicines. Please see our website for information for patients, pharmacists and doctors at https://t.co/xkJ31FSesr #patientsafety pic.twitter.com/MbtuVPXZms
— HPRA (@TheHPRA) July 5, 2018
According to Dr Lorraine Nolan, Chief Executive, HPRA, this is an emerging situation being managed in real time by the HPRA working with the European network of medicine regulators in order to determine the extent of the issue.
“Laboratory testing and risk assessments will provide more information as part of this co-ordinated European approach to establish the possible impact on patients who have been taking these medicines and to ascertain if other products may be impacted," she said.
[quote]"At this time, a precautionary recall of implicated products is the most appropriate action to protect patient health. We are engaging with healthcare professionals to manage this situation.”[/quote]
A list of the affected products is available on www.hpra.ie/valsartan.
- Digital Desk