There is currently a recall for the drug “Lisinopril 1A Pharma 10 mg – tablets”. The reason for this measure: contamination of the blood pressure medication with carcinogenic substances.
The Austrian Federal Office for Safety in Health Care (BASG) reports on its website about a recall of a blood pressure medication due to contamination with nitrosamines. These substances are considered carcinogenic.
Precautionary recall
According to the notification, the marketing authorization holder 1 A Pharma GmbH has informed its customers that the nitrosamine quantities of the medicinal product Lisinopril 1A Pharma 10 mg – tablets with the batch number KS6053 and the expiry date December 31, 2023 may be above the permissible acceptable daily dose. Therefore, this batch is being recalled as a precautionary measure.
Drug used to treat high blood pressure
Lisinopril is an ACE inhibitor that is used, among other things, to treat high blood pressure (hypertension), weak heart performance (symptomatic heart failure), blood pressure-related kidney disease and heart problems and after a stroke.
Carcinogenic nitrosamines
As the Federal Institute for Risk Assessment (BfR) explains in a communication (PDF), nitrosamines are chemical compounds that can form in the presence of substances such as nitrite and nitrogen oxides as well as certain secondary and tertiary amines.
The substances are found in, among other things, cured meat products, processed fish, beer and other alcoholic and non-alcoholic drinks and have also been detected in cheese, grains, processed vegetables, soy sauces and various oils. And medicines are also repeatedly contaminated with it.
Nitrosamines are considered carcinogenic in animal experiments, according to the Austrian public health portal “Gesundheit.gv.at”. It is also assumed that these compounds can lead to cancer in humans. However, to what extent is not yet clear. (ad)