Health Product Regulatory Authority Statement on Drug Recall

The following is an edited version of the statement issued by the HPRA on Thursday:

The Health Products Regulatory Authority (HPRA) states today that it is proceeding with a Preventive reminder of a number of specific drugs containing the active ingredient valsartan are used to treat high blood pressure and heart disease. A recall is underway throughout Europe following recent and emerging information that an impurity has been identified as part of the manufacturing process of a valsartan active substance manufactured in a factory in China. This active substance is used in a number of drugs marketed in Europe.

Valsartan is an important prescription drug used to treat high blood pressure and heart failure. It is also sometimes prescribed after a heart attack. HPRA advises patients not to stop taking these important medications, but to visit their pharmacist or doctor at a convenient time to discuss their treatment. All drugs containing valsartan are not affected by the recall. There are other drugs containing valsartan and other treatments available for patients. A list of relevant products is available at www.hpra.ie/valsartan.

L' Impurity N-nitrosodimethylamine (NDMA) that has been found is clbadified as probable carcinogen. At the present time, there is no evidence that this impurity has caused harm to patients; however, this booster is taken as a precaution to prevent further exposure to the impurity in the affected drugs while the investigation is ongoing.

According to Lorraine Nolan, CEO of HPRA, it is an emerging situation managed in real time by the HPRA in collaboration with the European Network of Drug Regulators to determine the magnitude of the question.

"Laboratory tests and risk badessments will provide more information as part of this coordinated European approach to establish the possible impact on patients who have taken these drugs and to determine whether or not Other products may be affected At the present time, a preventive recall of the products in question is the most appropriate action to protect the health of patients.We work with health professionals to manage this. situation. "

Patient Feedback:

" Patients should not stop taking their treatment abruptly.The health risk of abrupt discontinuation of this drug is higher than any potential risk presented by the patient. Impurity

"Patients taking drugs containing valsartan should, if possible, access the HPRA website at www.hpra.ie where a list of affected drugs is given.

"Patients should contact their pharmacist as soon as possible for further advice.

In addition to working closely with the European Regulatory Network, HPRA informs all stakeholders, including Department of Health, The Pharmaceutical Society of Ireland, The Irish College of General Practitioners and Other Health Professionals.

The HPRA will provide further updates on this issue as you go more information will be available.