The following is an edited version of the statement released by the HPRA on Thursday:
The Health Products Regulatory Authority (HPRA) today states it is undertaking a precautionary recall of a number of specific medicines containing the active ingredient valsartan that are used to treat blood pressure and heart conditions. A recall is under way across Europe following recent and emerging information that an impurity has been identified as part of the manufacturing process in a valsartan active substance manufactured at one facility in China. This active substance is used in a number of medicines marketed in Europe.
Valsartan is an important prescription medicine used to treat high blood pressure and heart failure. It is also sometimes prescribed after a heart attack. The HPRA advises patients not to stop taking these important medicines but to go to their pharmacist or doctor at an early opportunity to discuss their treatment. Not all valsartan medicines are affected by the recall. There are alternative valsartan-containing medicines and other treatments available to patients. A list of the affected products is available on www.hpra.ie/valsartan.
The impurity N-nitrosodimethylamine (NDMA) that has been found is classified as a probable carcinogen. At present there is no evidence that this impurity has caused any harm to patients; however, this recall action is being undertaken as a precautionary measure to prevent any further exposure to the impurity in the affected medicines whilst the investigation is ongoing.
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, the Irish College of General Practitioners and other healthcare professionals of this ongoing regulatory action.
The HPRA will provide further updates on this matter as more information becomes available.