New cancer-causing toxin found in recalled blood pressure pills

Desiree Burns
March 5, 2019

The latest recalls are for 38 lots of Valsartan and Amlodipine and Valsartan tablets produced by AurobindoPharma USA due to "the detection of trace amounts of an unexpected impurity found in the finished drug", and 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, from Torrent Pharmaceuticals.

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. Distributed nationwide online and by pharmacies and retailers including Walmart and Sam's Club, the drug was found to contain trace amounts of a potential human carcinogen, the New Jersey drug company said in a news release.

Recent federal research has found NDMA and NDEA's "risk to individual patients is very low", a U.S. Food and Drug Administration statement said.

The affected products come in 25, 50 and 100 milligram doses.

It added that it, too, "has not received any reports of adverse events related to this recall".

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The recall is the latest in an ongoing investigation into a class of drugs known as angiotensin receptor blockers or ARBs, which contain either valsartan, losartan or irbesartan and are used in patients with high blood pressure and other conditions.

Camber's recall is the second in a week of Losartan tablets. The recalled products vary in dosage from 40 mg to 320 mg, and have expiration dates that range from October 2019 to July 2020.

A series of drugs have been identified as potentially risky since an initial recall began seven months ago. This is the first ARB recall resulting from the presence of NMBA, which is the third type of nitrosamine impurity detected in ARB medicines. 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.

You can also find more information about the recall at this link.

Camber and Macleods are among the half dozen pharmaceutical firms that have recalled hypertension drugs found to contain possible carcinogens since early December.

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