Another blood pressure drug recalled due to cancer risk


On Thursday, the FDA announced Camber Pharmaceuticals is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg and 100 mg because N-Nitroso N-Methyl 4-amino butyric acid (NMBA) - a "potential human carcinogen" - was detected in a pharmaceutical ingredient of the product.

This is the first hypertension medication found to contain NMBA, but a handful of other recalls at the end of 2018 resulted from the potential contamination of N-Nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA)-two other potential carcinogens.

As for the latest recall, the FDA has reminded patients prescribed an ARB medication from a recalled lot to continue taking their medicine until their doctor or pharmacist provides a replacement or offers a different treatment option.

The recall noted that Camber has not received any reports of adverse events related to the recall.

This adds to the list of blood pressure medications recalled since October.

The affected Losartan tablets have expiration dates that run from September 2019 through June 2020.

Since last summer, drug companies have recalled hundreds of lots of blood pressure and heart medication drugs after tests showed small levels of potentially cancer-causing impurities.

A series of drugs have been identified as potentially risky since an initial recall began seven months ago.

"FDA scientists have developed novel and sophisticated testing methods specifically created to detect and measure N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) impurities in [angiotensin II receptor blocker (ARB)] medicines", Gottlieb wrote.

The recalled medication was distributed nationwide at retail pharmacies and from other mail-order pharmacies.

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. The company also makes losartan for other Indian drugmakers, including Torrent Pharmaceuticals Ltd. and Macleods Pharmaceuticals Ltd., that has been recalled for containing NDEA.

Camber and Macleods said the active pharmaceutical ingredient that contained the impurities came from Hetero Labs Limited, which is based in India.