Here’s how the FDA plans to reduce recalls of a heart and blood pressure medication
Hoping to cut down on recalls of blood pressure and heart drug losartan before it falls into shortage, the FDA announced Wednesday a temporary change to the acceptable intake amount of NMBA.
“To ensure patient access to losartan, the FDA will not object to certain manufacturers temporarily distributing losartan containing N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above...0.96 parts per million (ppm) and below 9.82 ppm until the impurity can be eliminated,” Wednesday afternoon’s announcement stated.
“The agency expects many companies will be able to manufacture losartan without nitrosamine impurities and replenish the U.S. supply in approximately six months.”
NMBA didn’t become a real concern until the start of this month, when losartan tablets made by Hetero Labs Limited for Camber Pharmaceuticals and Torrent Pharmaceutical got recalled for too much NMBA. Camber and Torrent supplied losartan to Legacy Pharmaceutical Packaging, so Legacy recalled 43 lots late Friday.
Losartan’s not in shortage yet, but another angiotensin II receptor blocker (ARB) drug, valsartan, is after months of recalls for too much NDEA. The FDA put a rush on an approval of a new generic version of valsartan last week.
“FDA reminds patients taking recalled losartan to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition,” Wednesday’s announcement said.
This story was originally published March 20, 2019 at 5:52 PM.
