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Active ingredient is contaminated with carcinogenic substances
The Federal Institute for Drugs and Medical Devices (BfArM) is currently informing about a Europe-wide recall of medicines for high blood pressure containing valsartan. The active ingredient of the Chinese manufacturer "Zhejiang Huahai Pharmaceutical" is apparently contaminated with a carcinogenic substance.
According to the BfArM, the active ingredient valsartan from the Chinese manufacturer is contaminated with N-nitrosodimethylamine. The international agency for cancer research of the WHO and the EU considers this substance to be carcinogenic. So far, there is no more precise information about the extent of the contamination. "As a precaution, all batches affected are recalled across Europe until the matter has been clarified," the BfArM wrote in a press release regarding the recall.
Europe-wide investigations are ongoing
According to the BfArM, there has already been a first scientific assessment of the hazard potential at European level. Further examinations are currently taking place all over Europe to ensure the protection of patients. In the course of this, it is also examined whether other medicinal products are affected by the contamination and if necessary further recall campaigns have to be started. The German Hypertension League e.V. and the German Society for Hypertension and Prevention also warn in a press release of drugs containing valsartan.
Those affected should not stop taking medication on their own
The BfArM warns patients who have to take such medication with valsartan not to refrain from taking it themselves. Instead, the responsible doctor should be consulted. In case of doubt, the omission of the drug poses a much higher health risk than the contamination. The German Hypertension League also recommends unsettled patients not to stop taking their blood pressure lowering medication themselves without consulting their doctor. As soon as an exact list of the affected drugs is available, a coordinated recall will be started.
Novartis Valsartan is not affected
Novartis Pharma GmbH responded to the recall and announced in a press release that its valsartan-containing products were not affected by this recall. According to the manufacturer, the following drugs with the active ingredient valsartan are produced in Ireland or Switzerland and are not affected by the contamination:
- Exforge HCT,
- Dafiro HCT,
- Provas Comp.
Which medications containing valsartan are affected?
Valsartan is an important active ingredient in the treatment of high blood pressure. It is also an ingredient in numerous combination products. There is currently no information about which drugs or which batches are specifically affected and which have to be recalled. A list of the medicines concerned is to be published shortly. (vb)