[ad_1]
To ensure patients' access to losartan, the US Food and Drug Administration has indicated that it would not oppose that some manufacturers temporarily distribute losartan, a medication for hypertension. arterial, containing N-nitroso-N-methyl-4-aminobutyric acid (NMBA) above the allowed temporary intake limit of 0.96 parts per million (ppm) and less than 9, 82 ppm until the impurity can be eliminated.
The agency expects that many companies will be able to manufacture losartan without nitrosamine impurities and replenish the US supply in about six months.
The scientists at the agency badessed the risk of exposure to NMBAs at concentrations up to 9.82 ppm and determined that there was no significant difference in terms of risk of cancer over a six-month period compared with exposure to NMBA life at 0.96 ppm. The distribution of losartan containing up to 9.82 ppm NMBA will help maintain an adequate supply of losartan while companies get approval for manufacturing processes that produce losartan without nitrosamine for patients.
The FDA reminds patients taking losartan recalled to continue taking their current medication until their pharmacist gives them replacement or their doctor prescribes another medication that addresses the same problem. Untreated hypertension (high blood pressure) causes an increased risk of heart attack and stroke. Untreated heart failure increases the risk of hospitalization and death. Untreated diabetic nephropathy (kidney disease) causes worsening of kidney disease.
Manufacturers must contact FDA drug shortage staff when their tests with losartan indicate NMBA concentrations exceeding the temporary acceptable intake limit of 0.96 ppm. The FDA will determine, on a case-by-case basis, whether batches containing NMBA greater than 0.96 ppm are to be released for distribution.
[ad_2]
Source link
