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The active substance is contaminated by carcinogens
The Federal Institute for Drugs and Medical Devices (BfArM) is currently informing about the pan-European recall of a drug for hypertension containing valsartan. The active substance of the Chinese manufacturer "Zhejiang Huahai Pharmaceutical" is apparently contaminated with a carcinogen.
According to BfArM, a batch of the drug is contaminated with the substance N-nitrosodimethylamine. This substance is considered carcinogenic by the International Agency for Research on Cancer (WHO) and the EU. More detailed information on the extent of the acceptance of impurities is not yet available. "The recall of all the lots concerned is therefore prudent on a European scale until the clarification of the facts," writes the BfArM in a press release on the recall
European studies are in progress
According to the BfArM, a first scientific badessment of the danger potential has already taken place at European level. Other investigations are underway across Europe to ensure the protection of patients. In the course, it will also be investigated if other drugs are affected by the contamination and, if necessary, further recall actions should be initiated. The German Hypertension Association and the German Society for Hypertension and Prevention warn in a press release about drugs containing valsartan
BfArM does not independently prevent patients who should take such drugs with valsartan. refrain from taking. Instead, a consultation with the responsible physician should take place. In case of doubt, the omission of the drug poses a health risk much higher than the contamination. The German Hypertension League also recommends unstable patients, in no way interrupt their antihypertensive drugs without consulting their doctor. A coordinated reminder will be launched as soon as an accurate list of drugs will be available
Novartis Valsartan is not affected
Novartis Pharma GmbH responded to the recall by announcing in a press release that its products containing of valsartan are not affected by this reminder are. The following drugs containing the active substance valsartan are produced by the manufacturer in Ireland or Switzerland and are not affected by the contamination:
- Entresto,
- Exforge,
- Exforge HCT,
- Diovan, [19659011] Codiovan,
- Dafiro,
- Dafiro HCT,
- Provas,
- Provas Comp.
Which drugs containing valsartan are affected?
Valsartan is an important substance used to treat high blood pressure. It is also an ingredient of many combination preparations. Currently, there is no information on drugs or batches that are actually affected and need to be recalled. A list of the medicines concerned will be published soon. (Vb)
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