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FDA permits temporary distribution of losartan with higher levels of impurity
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The FDA announced that it will not object to temporary distribution of losartan that contains an amount of an impurity above an interim acceptable intake limit until it can be eliminated.
Scientists with the FDA have determined that exposure to the impurity — N-Nitroso-N-methyl-4-aminobutyric acid — at levels up to 9.82 ppm for 6 months does not present a meaningful difference in the risk for cancer compared with a lifetime exposure to it at 0.96 ppm, according to an update from the FDA.
“The agency expects many companies will be able to manufacture losartan without nitrosamine impurities and replenish the U.S. supply in approximately 6 months,” the FDA stated in the update.
The impurity is one of two of interest in the numerous voluntary recalls of losartan since 2018. The impurity was found in active pharmaceutical ingredients manufactured by Hetero Labs Limited and has been classified as a probable human carcinogen by the International Agency for Research on Cancer.
Patients are asked to continue taking their current medication until their doctor or pharmacist provides a replacement treatment for the same condition, as untreated hypertension and HF increases risk for other events like stroke, MI, hospitalization and death.
Manufacturers are recommended to contact the FDA if they have tested losartan that contains levels of the impurity above 0.96 ppm. The FDA then would decide whether the lot should be released for distribution, according to the update.
“FDA continues to work with companies and international regulators to ensure products entering the U.S. market do not contain nitrosamine impurities,” according to the update.