More lots of Losartan, a drug used to treat high blood pressure and heart conditions, were recalled due to the presence of a potentially cancer-causing ingredient, said the U.S. Food and Drug Administration (FDA).
The FDA notice, posted on April 18, said that “trace amounts of an unexpected impurity” were discovered. Namely, the potentially carcinogenic chemical NMBA was found in the lots.
Torrent Pharmaceuticals hasn’t received any reports of adverse events linked to its latest recall, the notice said.
Patients who were prescribed the drug should continue taking them, said the FDA, which added that the “risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.”
Consumers can contact a pharmacist or doctor who can advise them about another form of treatment.
FDA Update
Several weeks ago, the FDA released a list of blood pressure medications that are safe to use, meaning they’re free of nitrosamine.The issue came to light in July 2018 when the FDA said it recalled several medicines with valsartan after impurities were found. Those medications were manufactured by a drugmaker in China.
The health agency’s statement added that the presence of nitrosamines is “not acceptable” in drug products.
“We’re also continuing to work with manufacturers to swiftly remove medications from the market if they contain a nitrosamine impurity at levels higher than the interim acceptable intake limits. Removing the affected medications from the market has led to shortages, and since then we’ve been working to mitigate and prevent shortages as often as possible,” the agency also said.
Common nitrosamines include N,N-dimethylnitrosamine (NDMA), N,N-diethylnitrosamine (NDEA), 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK).
For drugs marked “not present,” it means the FDA “has completed the comprehensive assessment noted above.”
Meanwhile, “TBD” means that “one or more parts of our assessment remain incomplete and the product remains acceptable for distribution and for patient use,” according to the release.
For the lots with “TBD,” “the product did have impurity levels above interim acceptable limits, however they have already been removed from the market,” adding that the agency is “prioritizing the assessments by those of highest patient need and in response to credible information about nitrosamine contamination.”