Recall of a number of Valsartan-containing film coated tablet products - Important information for patients and healthcare professionals

Notice type: Recall

Date: 05/07/2018

• Patients
• Carers 
• Pharmacists and
• other relevant Healthcare Professionals

The Health Products Regulatory Authority (HPRA) wishes to inform users and healthcare professionals of the following quality defect for specific Valsartan products.

• An impurity has been identified in the valsartan active substance used in the listed medicinal products; this impurity is N-nitrosodimethylamine (NDMA) and it has been classified as a probable human 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. 
• The active substance manufacturer, Zhejiang Huahai Pharmaceuticals, located in China, has reported that the impurity is linked to changes made to the manufacturing process.

This is an emerging issue. At present, the risk is theoretical and there is no direct evidence of harm having been caused by this impurity issue.  The HPRA is actively involved with the European Medicines Agency and with other medicines regulators to determine any possible impact on patients who have been taking these medicines.  In this regard, work is currently ongoing at a European level to better understand the potential impact of this impurity, and as a precautionary measure at this time, this recall is being undertaken

Table 1: List of Valsartan-containing products being recalled to Pharmacy Level

This active substance is used in a number of medicines marketed in Europe and recall actions are also underway across 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 Recall letter to pharmacists 05.07.2018
• A Dear Doctor letter intended for prescribers 05.07.2018

Advice to Patients

• It is important that you do not stop taking your valsartan medicine abruptly.The health risk of abruptly discontinuing the medicine is higher than any potential risk presented by the impurity.
• This issue only applies to the valsartan medicines listed above. If you are uncertain, your pharmacist can inform you if the medicine you are taking is affected.
• There are other valsartan medicines available which your pharmacist may dispense for you.If you are currently taking one of the above valsartan medicines, you should go back to your pharmacy at an early opportunity and seek an alternative medicine.
• In the event that your pharmacist is unable to dispense an alternative medicine for you, you should go to see your doctor at an early opportunity to discuss alternative medicines.
• When you are going to your pharmacy or doctor, you should bring your valsartan-containing medicine with you.
• If you have any concerns or questions concerning this issue, you should consult with your doctor or other healthcare professional.

Specific Information for Pharmacists and other Healthcare Professionals:

For All Pharmacists:

A recall letter is being issued on July 5^th, 2018, to all pharmacies/pharmacists in Ireland.  This recall letter is being emailed at the HPRA’s request by the Pharmaceutical Society of Ireland (PSI).  Paper copies of the recall letter will also be posted out to the pharmacies by the three pharmaceutical companies whose products are being recalled. 

Not all valsartan-containing medicines are affected by the recall. There are alternative valsartan-containing medicines and other treatments available to patients.  

Please perform the following actions:

• Immediately quarantine any units from the products listed above which you have in your pharmacy. For hospital pharmacies, this includes wards, clinics and any other relevant locations within your hospital. 

• Please return the quarantined units to your wholesaler within the next 7 days.  Your wholesaler will be in a position to advise you about receiving credit for the packs that you return

   

For Hospital Pharmacists only:

We kindly request that this communication is highlighted and made available to the relevant consultants/healthcare professionalsinfo@hpra.ie within your hospital; for example Cardiologists, Nephrologists, stroke physicians and other hospital consultants who may prescribe these products.

For Prescribers and All Healthcare Professionals:

We ask that Prescribers and other Healthcare Professionals consider the implication of this recall on existing stocks of available alternative Valsartan supplies and, whilst the investigation is ongoing, it is advisable not to commence new patients on valsartan-containing medicines where possible. 

Switching existing patients to alternative valsartan-containing medicines which are not on the above list should be feasible at present, given current stocks. However, the situation may change and you may have to consider other treatment options for patients requiring such medicines.

This an evolving situation and we will provide further updates as new information becomes available.

Contacts:
To contact the HPRA please call 01-6764971 or email info@hpra.ie