FDA not objecting to losartan with NMBA below 9.82 ppm remaining on the market

FDA said Wednesday that it will temporarily allow certain manufacturers to sell losartan containing N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the interim acceptable intake limit of 0.96 parts per million (ppm) and below 9.82 ppm until the impurity can be eliminated.

FDA said Wednesday that it will temporarily allow certain manufacturers to sell losartan containing N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the interim acceptable intake limit of 0.96 parts per million (ppm) and below 9.82 ppm until the impurity can be eliminated. FDA noted that it anticipates that many companies will be able to produce losartan without nitrosamine impurities and replenish supplies in the United States in about 6 months. Agency analyses of the risk of exposure to NMBA within the specified levels found "that it presents no meaningful difference in cancer risk over a 6-month time period when compared to a lifetime of exposure to NMBA at 0.96 ppm," FDA said. The agency cautioned patients taking recalled losartan to keep taking their current medicine until their pharmacist provides a replacement or their physician prescribes a different medication that treats the same condition.