EMA recommends sartan manufacturers review processes to avoid contamination
The European Medicines Agency (EMA) has recommended that manufacturers making sartan blood pressure medicines review their processes after impurities were found in a small number of products.
The impurities, N-nitrosodimethylamine (NDMA) and N‑nitrosodiethylamine (NDEA), are classified as possible human carcinogens and, under the recommendations, companies would have to adhere to strict limits on the levels of the impurities that can be found in sartan medicines for two years.
Products found to contain either NDMA or NDEA above the set limits would not be allowed in the EU.
This comes after the Medicines and Healthcare products Regulatory Agency issued a further recall of irbesartan-containing medication from UK pharmacies, due to NDMA and NDEA contamination, on 28 January 2019.
Several valsartan products were recalled in 2018.
Irbesartan is one of five active substances subject to the new limits, in addition to candesartan, losartan, olmesartan and valsartan. The set limits vary for each active substance.
The EMA said that these impurities can form during the production of sartans containing a tetrazole ring under certain conditions and when certain solvents, reagents, and other raw materials are used.
It added that impurities could also be present “because manufacturers had inadvertently used contaminated equipment or reagents in the manufacturing process”.
After the two year transition period, in which manufacturers are expected to adjust their processes to limit contamination, companies will have to demonstrate that their sartan products contain none of these impurities before they can be used in the EU.
The EMA’s recommendations for NDMA and NDEA are now awaiting a legally binding decision from the European Commission.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206101
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