Another popular blood-pressure med recalled for carcinogen risk
- Losartan potassium tablets sold by Macleods Pharmaceuticals were recalled after trace amounts of a probable carcinogen known as NMBA were found in the popular blood-pressure medicine.
- "The risk of developing cancer in a few patients following long-term use of the product cannot be ruled out," the FDA noted.
- Since 2018, there have been at least 19 recalls by manufacturers of versions of losartin over cancer fears,
- The losartin recall follows similar recalls of the heart drug valsartan, also prescribed to treat blood-pressure issues.
Americans who take prescription drugs to control blood pressure should check their medical cabinets once again. Macleods Pharmaceuticals is recalling another 32 lots of widely used losartan potassium tablets sold nationwide after finding trace amounts of a probable carcinogen.
The recall involves losartan and potassium/hydrochlorothiazide combination pills found to contain N-Nitroso-N-methyl-4-aminobutyric acid, or NMBA, according to a notice posted by the U.S. Food and Drug Administration.
"Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out," the notice stated.
NMBA is a naturally occurring substance in certain foods, drinking water, air pollution and industrial processes, and has been classified as a probable human carcinogen by the International Agency for Research on Cancer.
The impurity was detected in an ingredient made by India's Hetero Labs, among the overseas manufacturers tied to a series of recalls over the past year. The latest recall is the second for the same reason by Macleods Pharmaceuticals, which in February recalled another lot of its combination tablets.
Since 2018, there have been at least 19 recalls by manufacturers of versions of losartin over cancer fears, including a March recall of 87 lots of losartin made by Camber Pharmaceuticals.
The FDA cautions that consumers should continue to take their blood-pressure medication regardless of whether it's been recalled until they can consult with their physician.
The federal agency last week said it was reviewing the findings of online pharmacy Valisure, which told the FDA it had detected another cancer-causing chemical in blood-pressure pills made by companies including Novartis. The week-ago filing to the FDA involved dimethylformamide, or DMF, a solvent detected in the heart drug valsartan, according to Valisure.
Multiple versions of generic valsartan have been recalled since last summer, when NMBA was found in a Chinese-made version of valsartan, as drug that for decades has been used to treat hypertension.
The latest recall involves the following lot and batch number and the expiration dates on the packaging:
Losartan potassium tablets 50 mg:
- BLl711A, BLl710A, November 2019
Losartan potassium and hydrochlorothiazide tablets 50 mg/ 12.5 mg:
- BLK719A, BLK720A, BLK721A, BLK722A, BLK723A, BLK724A, September 2019
- BLK725A, BLK726A, October 2019
- BLK804A, BLK806A, January 2020
- BLK825A, BLK826A, October 2021
Losartan potassium and hydrochlorothiazide tablets 100 mg/ 12.5 mg:
- BLM716A, BLM717A, July 2019
- BLM719A, BLM720A, August 2019
- BLM721A, BLM722A, September 2019
- BLM723A, BLM724A, BLM725A, October 2019
- BLM726A, November 2019
- BLM802A, BLM803A, December 2019
- BLM825A, BLM826A, BLM827A, September 2021
Losartan potassium and hydrochlorothiazide tablets 100 mg/ 25 mg:
- BLM716A, BLM717A July 2019
- BLM719A, BLM717A, July 2019
- BLM719A, BLM720A, August 2019
- BLM721A, BLM722A, September 2019
- BLM723A, BLM724A, BLM725A, October 2019
- BLM726A, November 2019
- BLM802A, BLM803A, December 2019
- BLM825A, BLM826A, BLM827A, September 2021
