FDA Allows Losartan With NMBA Level Below 9.82 ppm to Remain on Market
In an effort to ensure patient access to losartan, the U.S. Food and Drug Administration (FDA) announced it will not object to certain manufacturers temporarily distributing 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. The agency expects many companies will be able to manufacture losartan without nitrosamine impurities and replenish the U.S. supply in approximately six months.
This decision follows an evaluation by agency scientists which determined that the risk of exposure to NMBA at levels up to 9.82 ppm presents no meaningful difference in cancer risk over a six-month time period when compared to a lifetime of exposure to NMBA at 0.96 ppm. By allowing the distribution of losartan containing NMBA up to 9.82 ppm, the agency hopes to help maintain an adequate losartan supply while companies obtain approval for manufacturing processes that produce nitrosamine-free losartan for patients.
FDA reminds patients prescribed recalled losartan to continue taking their current medicine until their pharmacist provides a replacement or their clinician prescribes alternative treatment. The agency continues to work with companies and international regulators to ensure products entering the U.S. market do not contain nitrosamine impurities.
While the FDA's investigation on this issue is ongoing, the ACC is actively working to keep members up-to-date on the latest information. Learn more on FDA’s website.
Keywords: ACC Advocacy, Losartan, Pharmacists, United States Food and Drug Administration, Drug Recalls, Nitrosamines
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