Investigation into sartan medicines broadens after ‘potent’ contamination
Following the valsartan scandal, regulators have widened their investigations into other ‘sartans’ and found one case where a batch of losartan medication contained a carcinogenic impurity.
N-nitrosodiethylamine (NDEA) is named by the WHO as a “potent carcinogen” but is a different substance to that found in the valsartan cases that began the entire investigation, during which numerous cases of N-Nitrosodimethylamine (NDMA) being found in medicine were observed.
The batch of losartan containing impurities, detected by German regulatory authorities, was produced by Indian active pharmaceutical ingredient (API) producer, Hetero Labs.
The company did not respond to a request for comment.
The net widens
As a result of the European Medicines Agency (EMA)’s discovery, the regulator announced that it would be broadening its investigation to include four other sartan medications: candesartan, irbesartan, losartan and olmesartan.
The EMA revealed that it had not concluded exactly why the sartan medications seem to have an issue with impurities but did note that they are produced with a specific ring structure, “which could potentially lead to the formation of impurities such as NDEA.”
Beyond the announcement, the EMA stated: “Further tests are required to determine the extent of the contamination and whether impurities are present in sartan medicines above levels that can be considered acceptable.”
The agency tempered the news by adding that the levels of contamination discovered in the batch of losartan medication was not enough to pose an “immediate risk” to patients.
