Long overdue recall because of cancer risk in high blood pressure with valsartan

Active substance is contaminated with carcinogenic substances

The Federal Institute for Drugs and Medical Devices (BfArM) is currently informing about a pan-European recall of valsartan-containing medicines for hypertension. 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. This substance is considered by the International Agency for Research on Cancer of the WHO and the EU as carcinogenic. More detailed information on the extent to which the impurities assume are not yet available. "The recall of all affected batches is therefore precautionary Europe-wide until the clarification of the facts," writes the BfArM in a press release on the recall.

The Federal Institute for Drugs and Medical Devices (BfArM) informs about a pan-European recall of valsartan-containing medicines for hypertension. (Image: Photographee.eu/fotolia.com)

Europe-wide investigations are under way

According to the BfArM, there was already a first scientific assessment of the hazard potential at European level. Further investigations are currently taking place across Europe to ensure patient protection. In the course is also examined whether other drugs are affected by the contamination and, if necessary, further recall actions must be started. The German Hypertension League e.V. and the German Society for Hypertension and Prevention warn in a press release about valsartanhaltigen drugs.

Patients should not discontinue medication on their own

The BfArM warns patients who need to take such medications with valsartan, not to dispense on their own initiative. Instead, a consultation with the responsible doctor should take place. When in doubt, the omission of the drug poses a much greater health risk than contamination. The German Hypertension League also recommends unsettled patients not to discontinue their antihypertensive medicines without consulting their doctor. Once a precise list of the medications concerned is available, a coordinated recall will be initiated.

Novartis Valsartan is not affected

Novartis Pharma GmbH reacted to the recall and announced in a press release that its valsartan-containing products were not affected by this recall. The following medicines containing the active substance valsartan are produced according to the manufacturer's instructions in Ireland or Switzerland and are not affected by the contamination:

• Entresto,
• Exforge,
• Exforge HCT,
• Diovan,
• Codiovan,
• Dafiro,
• Dafiro HCT,
• Provas,
• Provas Comp.

Which valsartan-containing medicines are affected?

Valsartan is an important drug for the treatment of high blood pressure. It is also an ingredient in numerous combination preparations. Currently there is no information about which drugs or which batches are actually affected and need to be recalled. A list of the drugs concerned will be published shortly. (Vb)