A number of medicines used to treat blood pressure and heart conditions are being recalled. It’s after an impurity was identified in the valsartan ingredient manufactured at a plant in China.
The Health Products Regulatory authority 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’s 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.
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. 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.”
Advice to Patients:
- Patients should not stop taking their treatment abruptly. The health risk of abruptly discontinuing this medicine is higher than any potential risk presented by the impurity.
- Patients who are taking valsartan-containing medicines should, if possible, access the HPRA website at www.hpra.ie where a list of the affected medicines is given.
- Patients should contact their pharmacist at an early opportunity for further advice.
In addition to working closely with the European regulatory network on the investigation, the HPRA is informing all stakeholders including the Department of Health, the Pharmaceutical Society of Ireland (PSI), the Irish College of General Practitioners (ICGP) and other healthcare professionals of this ongoing regulatory action.