According to the results of laboratory studies, NDMA is regarded as a probable human carcinogen (a substance that can cause cancer). The detection of NDMA was a surprise, which is attributed to changes in the manufacture of the active substance.
While the assessment is ongoing, the national competent authorities for the circulation of medicinal products in the EU are recalling medicinal products containing valsartan manufactured from a substance produced by Zhejiang Huahai Pharmaceuticals.
Medicinal products containing valsartan are prescribed to treat patients with high blood pressure in order to reduce complications such as myocardial infarction and stroke. Valsartan is also used in patients who suffer from heart failure or have recently had a myocardial infarction.
During the assessment, the EMA will examine the level of NDMA in the relevant valsartan-containing medicinal products, its possible impact on patients who have taken them, and possible measures to reduce or remove this impurity in batches to be manufactured in the future. As a precaution, the assessment will also examine whether other valsartan products may contain this impurity.
The evaluation will be carried out by the EMA Committee for Medicinal Products for Human Use (CHMP).
Information for patients
An unexpected impurity was detected in the active pharmaceutical ingredient (API) used to manufacture some medicinal products containing valsartan.
Only certain valsartan-containing medicinal products in the EU had this impurity.
Do not stop taking medicinal products containing valsartan unless your doctor or pharmacist has advised you to do so.
At your next visit to the doctor, you may be prescribed a different medicinal product containing valsartan (or alternative treatment).
If you have any questions about your treatment, contact your pharmacist, who can inform you whether the circulation of the medicinal product containing valsartan that you are taking has been suspended.
If you are participating in a clinical trial and taking a medicinal product containing valsartan, and you have any questions, please consult your treating physician.
EMA will assess whether the impurity may pose any risk to patients. Further information will be provided if available.
Information for healthcare professionals
N-nitrosodimethylamine (NDMA) was detected in valsartan API produced by Zhejiang Huahai Pharmaceuticals.
As a result, medicinal products containing valsartan manufactured from the substance produced by Zhejiang Huahai Pharmaceuticals are being recalled in the EU.
National competent authorities are addressing healthcare professionals with information on medicinal products containing valsartan that must be recalled.
EMA is currently assessing the potential impact on patients who have been exposed to NDMA by taking valsartan medicines. Further information will be provided when available.
More about medicines
Valsartan is an angiotensin II receptor antagonist used to treat hypertension (high blood pressure), recent myocardial infarction and heart failure. It may be prescribed alone or in combination with other medicinal products.
The EMA assessment covers all medicinal products containing valsartan manufactured from the active substance produced by Zhejiang Huahai Pharmaceuticals. As a precautionary measure, the review will also assess whether other valsartan products may contain this impurity.
More about the procedure in the EU
The assessment of medicinal products containing valsartan manufactured from a substance produced by Zhejiang Huahai Pharmaceuticals was registered on 5 July 2018 at the request of the European Commission pursuant to Article 31 of Directive 2001/83/EC.
The assessment will be carried out by the CHMP, which is responsible for questions concerning medicinal products for human use and which will adopt the EMA’s opinion. The CHMP’s decision will be sent to the European Commission, which will adopt the final legally binding decision applicable in all EU Member States.
