Valsartan medication review - update.
The European Medicines Agency (EMA) is currently conducting an investigation into the potential health effects on patients who have taken valsartan medicines containing the impurity NDMA. NDMA is an impurity found in the active ingredient valsartan, which was manufactured by the Chinese company Zhejiang Huahai Pharmaceuticals. NDMA is classified as a probable human carcinogen based on animal studies. It is also present in small amounts in some foods and water supplies, but NDMA is not expected to cause harm if ingested in very small amounts.
According to a preliminary risk assessment, the EMA estimates that there could be one additional cancer case for every 5,000 patients who took the affected drugs daily at the highest dose of valsartan (320 mg) over a seven-year period. This estimate is based on the average concentrations of the impurity (60 ppm = parts per million) detected in Zhejiang Huahai Pharmaceuticals' API. This potential cancer risk was indirectly extrapolated from animal studies and should in any case be considered in relation to the natural lifetime (and NDMA-independent) cancer risk in the EU (1 case per 3 persons) and also NDMA exposure from other sources. The preliminary estimate is based on the assumption that the NDMA present in the active ingredient was also transferred to the final product in the same amount.
Pharmaceutical companies that have used the active ingredient from Zhejiang Huahai's production in their valsartan drugs must now test samples they have kept to determine the actual NDMA levels in the final products (=finished drugs). Additional checks will also be carried out by the EU's official control laboratories. Once the data from all these tests are available, the EMA, together with the national medicines authorities, will be able to provide further and more certain information on the risk.
It is important to note that there is no immediate risk to patients. Patients taking the affected medicines who have not yet been switched to an alternative should not discontinue their medicines without first consulting their physician or pharmacist. Valsartan drugs are used in patients with diseases of the blood circulation (hypertension, recent myocardial infarction and heart failure). Therefore, it is not advisable to abandon or discontinue treatment if treatment has been prescribed. Unauthorized discontinuation without a change and without prior physician consultation far exceeds the risk from NDMA contamination.
All valsartan drugs containing the active ingredient from Zhejiang Huahai Pharmaceuticals have been recalled from pharmacies in Austria and the EU. However, other valsartan medicines are still available that are not affected by the contamination. Patients seeking more information about their treatments should contact their physician or pharmacist.
NDMA is an unexpected impurity that is believed to have formed as a byproduct of an altered synthesis process after Zhejiang Huahai made changes to its manufacturing process in 2012. No other active ingredients manufactured by the company are affected.
Recommendations for patients:
If you have further questions or feel unsure, please contact your healthcare professional or pharmacist.
Safety information about the valsartan recall and affected medicines:
Official recall letter link on BASG website:
European Medicines Agency (EMA) Press Releases:
Dr. Christoph Baumgärtel, Tel.: +43 505 55-36004
Queries (for media):
Communications Management, Tel.: +43 505 55-25000