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null EMA conducted a preliminary assessment of the effect of impurities in medicines containing valsartan on human health

EMA conducted a preliminary assessment of the effect of impurities in medicines containing valsartan on human health

9.8.2018

The European Medicines Agency (EMA) conducted a preliminary assessment of the possible effects of valsartan medicines containing an impurity called NDMA manufactured by a Chinese factory (Zhejiang Huahai Pharmaceuticals).

Based on the preliminary assessment, it is estimated that approximately one in 5,000 patients would develop cancer associated with exposure to NDMA at the highest valsartan dose (320 mg) every day for 7 years. This estimate is based on average levels of this impurity detected in the active substance and on the assumption that the impurity is carried over in the final product in the same amount.

The possible cancer risk has been assessed based on the results from animal studies and should be considered in the context of the lifetime risk of cancer (1 in 3 in the EU) and NDMA exposure from the environment.

Marketing authorisation holders are requested to test samples of all products containing valsartan, when the active substance has been supplied by the Chinese factory in question. The aim of the testing carried out by the European Official Medicines Control Laboratories is to determine the actual impurity levels. When the results are available, EMA will be able to assess the possible risk that the impurity may have posed for patients in more detail.

EMA reminds that the impurity does not pose an immediate risk to patients. Patients using valsartan have already been advised to contact a pharmacy if the distribution of the product they are using is banned (products listed in Fimea's news of 4 July) The pharmacy can replace the product with another valsartan product. If a substitute product of same strength is not available, the prescriber needs to be contacted for a new prescription.

Valsartan is a medicinal substance that is used for treating high blood pressure and congestive heart failure. Patients should not stop taking their medicines without consulting their doctor.

The detected impurity (NDMA) was unexpected, and it is believed to have formed as a side product after the factory introduced changes to its manufacturing process in 2012.

The European Medicines Agency (EMA) is investigating the possible health effects caused by NDMA found in the products containing valsartan manufactured by Zhejiang Huahai Pharmaceuticals. In Finland, the distribution of these products was banned on 4 July 2018. The ban concerns less than one third of the valsartan products marketed in Finland.

Read more:

EMA's press release, 2 August 2018

EMA jatkaa valsartaanilääkkeiden tutkimusta (EMA continues to investigate medicines containing valsartan, 17 July 2018)

EMA tutkii kiinalaistehtaan valsartaania sisältävät lääkkeet (EMA is inspecting medicines containing valsartan manufactured in a Chinese factory, 6 July 2018)

Kaikki valsartaania sisältävät lääkkeet eivät ole jakelukiellossa (The distribution ban does not apply to all medicines containing valsartan, 5 July 2018)

Blood pressure medicines withdrawn from the market due to quality problems (4 July 2018)

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  • Eeva Sofia Leinonen, Head of Division, tel. +358 29 522 3379
  • Maija Kaukonen, Head of Division, tel. +358 29 522 3308
  • E-mail address format: firstname.lastname@fimea.fi