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The European Medicines Agency (EMA) said it is reviewing drugs containing the active substance valsartan provided by Zhejiang Huahai Pharmaceuticals, a company from Linhai, China.
The review was triggered after the company detected an impurity. N-nitrosodimethylamine (NDMA), in the active substance valsartan that the company provides to manufacturers producing some of the drugs of valsartan available in the EU.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on laboratory test results. The presence of NDMA was unexpected and would be related to changes in the way the active substance was manufactured, said the EMA.
During the review, the national authorities of the EU are recalling drugs containing valsartan provided by Zhejiang Huahai.
In Bulgaria, the national agency in charge of drugs announced that it had blocked the sale of many drugs against high blood pressure and heart conditions. The list is here . Doctors have advised that people should not stop taking medication without first consulting a specialist.
Valsartan medications are used to treat patients with high blood pressure to reduce complications such as heart attacks and strokes. It is also used in patients who have had heart failure or a recent heart attack.
The EMA will review the NDMA levels in these valsartan drugs, its possible impact on the patients who took them and the steps that can be taken to reduce or eliminate the impurity of future batches produced by the patient. # 39; company. As a precautionary measure, the review will also consider whether other drugs valsartan may be affected
The review will be conducted by the Committee for Medicinal Products for Human Use (CHMP) of the EMA .
Patient Information:
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An unexpected impurity was found in the active ingredient used to make certain drugs valsartan
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Only certain drugs valsartan in the EU are concerned and they are recalled .
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You should not stop taking vsartan unless you are told
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You may be receiving a different treatment with valsartan (or other treatment) when you take your next prescription.
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If you have questions about your treatment, talk to your pharmacist. who can tell you if your medicine is being recalled.
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If you are in a clinical trial with valsartan and you have questions, talk to the doctor who treated you in the trial.
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The EMA will evaluate whether there is a risk of presenting a risk to patients.
Information for Health Professionals
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N-Nitrosodimethylamine (NDMA) was detected in the active substance valsartan produced by Zhejiang Huahai Pharmaceuticals.
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As a result, drugs containing valsartan National authorities communicate with pharmacists to obtain information about medications to be recalled.
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The EMA is currently evaluating the potential impact on patients of exposure to NDMA in valsartan-based drugs.
Valsartan is an angiotensin II receptor antagonist, used to treat hypertension (high blood pressure), recent heart attacks, and heart failure. It is available alone or in combination with other active substances
The review covers all medicines containing valsartan provided by Zhejiang Huahai Pharmaceuticals. As a precaution, the review will also consider whether other drugs valsartan may be affected.
Learn more about the procedure:
The review of drugs containing valsartan provided by Zhejiang Huahai Pharmaceuticals was triggered on July 5, 2018 at the request of the European Commission, under Article 31 of Directive 2001/83 / EC, the EMA stated:
The review will be carried out by the Committee for Medicinal Products for Human Use (CHMP), which is responsible for matters relating to medicinal products for human use, adopts the 39, opinion of the Agency. The opinion of the CHMP will then be transmitted to the European Commission, which will make a final legally binding decision applicable in all EU Member States.
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