The European Medicines Agency (EMA) is reporting that a third sartan medication has been found to contain the probable human carcinogen N-nitrosodiethylamine (NDEA).
The EMA says low levels of NDEA have been found in irbesartan made by the Indian company, Aurobindo Pharma. On 8 October 2018, the European Directorate for the Quality of Medicines and HealthCare suspended Aurobindo’s Certification of Suitability (CEP), effectively stopping the supply of irbesartan-containing products from this company in the European Union (EU). National authorities are currently considering whether to recall medicines containing Aurobindo’s irbesartan products.
Aurobindo is the third company to come under investigation by the EMA in relation to contaminated sartan products.
In July 2018, the detection of N-nitrosodimethylamine (NDMA) and NDEA in valsartan from the Chinese company Zhejiang Huahai led to an EU-wide review of all valsartan medicines. The review was subsequently extended to other sartan medicines when very low levels of NDEA were found in losartan made by Hetero Labs in India.
The risk of cancer from the contaminated products is estimated to be in the order of one in 5,000 for an adult taking an affected medicine at the highest dose (320 mg) every day from July 2012 to July 2018.