Blood pressure medicines withdrawn from the market due to quality problems

20.8.2018 an update to the list of medicines withdrawn from the market

European medicinal authorities are currently investigating quality problems concerning the medicinal substance valsartan. The valsartan manufactured by a Chinese pharmaceuticals manufacturer (Zhejiang Huahai Pharmaceutical Co.) has been found to contain impurities. The formation of the impurity relates to the synthesis method used in the manufacture of the medicinal substance concerned. Valsartan is a medicinal substance that is used for treating high blood pressure and congestive heart failure.

A distribution ban has been imposed on medicinal products that contain valsartan produced by the manufacturer concerned, and patients who use them are advised to contact a pharmacy for a substitute product.

In Finland, a distribution ban has been imposed on the following products (marketing authorisation holder indicated in brackets):

• Valsarstad (Stada Nordic)
• Valsartan Actavis (Actavis Group PTC ehf)
• Valsartan Orion (Orion Pharma)
• Valsartan ratiopharm (ratiopharm GmbH)
• Valsartan Sandoz (Sandoz A/S)
• Valsartan/hydroklorotiazid Actavis (Actavis Group PTC ehf)
• Valsartan/hydrochlorothiazide Orion (Orion Pharma)
• Valsartan/hydrochlorothiazide Ratiopharm (ratiopharm GmbH)
• Valsartan/hydrochlorothiazide Sandoz (Sandoz A/S)
• Valsarstad Comp (Stada Nordic)
  As from 20 August 2018, Fimea has lifted the prohibition on distributing those batches in the manufacture of which another manufacturer’s medicinal substance has been used.

 

The impurity found from the products is N-Nitrosodimethylamine (NDMA), which has been found to increase the risk of cancer in animal tests. There is no certainty as to how much this impurity may increase the risk of cancer in humans. In the present state of knowledge, there is no immediate risk posed to patients, but as a precautionary measure, those who are using the aforementioned products are advised to contact a pharmacy to get a substitute product. However, it is important that you do not stop your current medicinal treatment before contacting your attending doctor. The marketing authorisation holders will provide pharmacies with instructions on the practical measures related to the substitution.

In Finland, the market share of the products banned from distribution is around 30 per cent of all medicines that contain valsartan. The products available as substitute medicines include Diovan, Diovan comp, Valsartan KRKA and Valsartan/Hydrochlorthiazide KRKA.

The European Commission, the European Medicines Agency EMA and national medicinal authorities are currently investigating the amounts of NDMA present in medicines and their potential effects on patients. European medicinal authorities will also investigate all the other medicinal products that are prepared using the same synthesis method.

Fimea will continue investigating the matter in collaboration with other European medicinal authorities.

If you are currently using a valsartan-containing medicine now being withdrawn:

• Do not stop taking the congestive heart failure or high blood pressure medicine before you have received a substitute medicine.
• Contact a pharmacy to replace your medicine with an interchangeable product.
• If you have any questions about your medication, contact your doctor.

 

More information about the production chain of medicines