The FDA will allow some manufacturers to sell blood pressure medications containing a probable cancer-causing impurity in a temporary effort to mitigate a shortage, according to Reuters.
Drugmakers with losartan still on the market will be allowed to sell the drug if it has below 9.82 parts per million of N-Nitroso-N-methyl-4-aminobutyric acid. NMBA is a known animal carcinogen, and may cause cancer in humans.
The FDA will allow the sale of the drugs until the impurity is eliminated.
Since last summer, there have been a string of recalls related to generic blood pressure medications. Two other likely carcinogenic impurities — N-Nitrosodimethylamine and N-Nitrosodiethylamine — were detected in generic blood pressure drugs irbesartan and valsartan.
The recalls prompted the FDA to warn providers and the public about the possibility of a shortage of generic blood pressure medication.
On March 12 the FDA approved a new generic version of valsartan to ease the shortages triggered by the recalls.
The FDA said it expects companies to be able to manufacture losartan without NMBA and replenish supplies in the U.S. in about six months.