FDA eases standards to avoid blood pressure drug shortages

Mar 21, 2019

The FDA announced that it will temporarily allow certain manufacturers to continue distributing losartan containing impurities slightly above the interim acceptable intake limit, in order to avoid shortages of certain blood pressure drugs.

The agency has been recalling lots of losartan tablets after finding traces of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), a cancer-causing impurity. Now the FDA says manufacturers can distribute tablets containing NMBA above the interim acceptable intake limit of 0.96 parts per million (ppm) and below 9.82 ppm, in order to maintain adequate losartan supply while companies obtain approval for manufacturing processes that produce nitrosamine-free losartan.

The FDA estimated that companies will be able to manufacture losartan without nitrosamine impurities and replenish the U.S. supply in approximately six months. Agency scientists evaluated the risk of exposure to NMBA at levels up to 9.82 ppm and determined that it 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.

Read the FDA statement.