High blood pressure drugs recalled due to impurity

The Health and Youth Care Inspectorate is recalling a number of medicines for high blood pressure and heart failure “as a precaution”. Excessive concentrations of an “azide impurity,” a substance that may be carcinogenic in certain quantities, have been found in the drugs. The Inspectorate reports that Tuesday. These are medicines containing losartan, valsartan or irbesartan from various pharmaceutical companies.

The batches of medicines that have been rejected are now being removed from the market as a precaution, the Inspectorate has decided in consultation with the manufacturers and the Medicines Evaluation Board. According to the regulator, there is no direct risk for patients taking the medicines. All losartan, valsartan and irbesartan manufacturers are currently adapting their production process. New drugs are tested for the presence of the impurity. Products with too high an impurity content may no longer be placed on the market.

Strict Limit

The impurity found in the medicines is also known as AZBT, according to the Inspectorate. This occurs during the production of the active ingredient of the medicines concerned. Laboratory tests have shown that this substance may be carcinogenic. The limit for that impurity is strict, says the Inspectorate. “If 100,000 patients use the maximum dose of a drug for their entire life, which contains the maximum permitted amount of the impurity daily, then 1 of these 100,000 people may develop a form of cancer.”

The registration numbers of the medicines in which the potentially toxic substance has been found are known to pharmacists. They contact its users. Patients can also contact the pharmacists themselves to obtain a replacement medicine. The Inspectorate says that there sufficient replacement medicines against high blood pressure or heart failure are in stock. The Inspectorate also has a list online with an overview of the drugs that have been rejected.

In recent years, medicines have been recalled more often because they contained carcinogens. In 2018, for example, 180,000 people were found in the Netherlands valsartan contaminated with NDMA to use. Ultimately, 3.6 million boxes of valsartan containing too high concentrations of the substance were destroyed. Be in November 2020 diabetes drugs recalled which also contain too much NDMA. It then concerned the drug metformin, which is used by 655,000 patients.