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Valsartan and Irbesartan: New Recalls for Hypotensive Products
In the past few months, several recalls for hypertension medication with valsartan have been launched after it became known that the preparations were contaminated with dangerous substances. Now further blood pressure lowerers are being recalled.
Recall for medicinal products containing valsartan
At the beginning of July, the Federal Institute for Drugs and Medical Devices (BfArM) started a recall for medicinal products containing valsartan from the Chinese manufacturer "Zhejiang Huahai Pharmaceuticals" because carcinogenic contaminants had been found in the hypotensive preparations. In September it was then confirmed that preparations from the Indian company Hetero Labs were also contaminated. And now it is reported that more blood pressure lowerers are being recalled.
Contamination with carcinogenic substances
According to a report by the Deutsche Apothekerzeitung, Valsartan from Mylan Laboratories Limited in Hyderabad, India, may not be used for the manufacture of medicinal products containing valsartan for the EU until further notice.
This is because contamination with N-nitrosodiethylamine (NDEA) was found in some batches.
Both NDEA and the chemically related substance N-nitrosodimethylamine (NDMA), which have already been found in other sartans, are classified as potentially carcinogenic.
Batches of Irbesartan Heumann 300 mg are currently being recalled, reports the German Hypertension League in a message published by the Science Information Service (idw).
For the treatment of various diseases
According to the BfArM, sartans (including candesartan, irbesartan, losartan, olmesartan and valsartan) are so-called angiotensin II receptor antagonists, which are used to treat arterial hypertension (high blood pressure).
These medications are also used for heart failure (heart failure), after a recent heart attack, or for patients who have kidney disease and who also have hypertension and type 2 diabetes mellitus.
The preparations are available alone or in combination with other active ingredients.
In some cases, these remedies are used to lower high blood pressure because taking other medications leads to persistent coughing in patients.
Do not simply stop the blood pressure lowering
According to the Deutsche Apothekerzeitung, the European Medicines Agency (EMA) points out that the new discoveries pose no immediate risk for patients.
As with the previous impurities, it is advised not to stop the blood pressure therapy by hand.
Rather, patients should discuss their further treatment with a doctor or pharmacist.
At a press conference of the German Hypertension League on Thursday, the question of which alternative therapies remain should also be addressed. (ad)