Two drug companies recalled more than 100 lots of popular blood pressure medications this week after discovering trace amounts of potentially cancer-causing ingredients known as N-Nitroso N-Methyl 4-amino butyric acid (NMBA) and N-nitrosodiethylamine (NDEA).
The FDA said in a statement it was investigating the formation of these impurities, which were reported to be made by previously unknown to drug developers. A full record of recalled drugs is offered from the FDA.
The medicine is used to treat high blood pressure and congestive heart failure. Hetero Labs Limited produced the active ingredient.
Amid the recalls of other ARBs, or angiotensin receptor blockers, medications Commissioner Dr. Scott Gottlieb said in the news release that though consumers face few immediate health threats from the recalls, the agency is "deeply concerned" and pursuing an investigation into the possible presence of a third impurity. FDA scientists have developed novel and sophisticated testing methods specifically created to detect and measure N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) impurities in ARB medicines.
"We are making important strides at understanding how these impurities form and we are continuing to examine if nitrosamine impurities may also arise during the manufacture of other ARB drug products", Gottlieb wrote. Friday, the FDA said it estimated the same for NMBA. However, there's a catch. And that's what happened in the case of tainted ARBs. The agency said that the risk of a patient who took a recalled ARB getting cancer is low.
The FDA said Torrent Pharmaceuticals Ltd is expanding its voluntary recall to include 114 additional lots of losartan-containing medication due to unacceptable amounts of NMBA in the losartan manufactured by Hetero Labs.
But patients should speak with their doctor to discuss the recall before they stop taking the drug.
And then there's Macleods Pharmaceuticals Limited, which announced on February 22, 2019, that it was initiating a recall on just one of its lots of Losartan tablets after traces of NDEA were detected by officials.