FDA expands recall again for heart drug

Posted at 12:07 PM, Jan 04, 2019
and last updated 2019-01-04 12:09:33-05

The recall of popular heart drugs has expanded yet again.

The US Food and Drug Administration said Thursday that Torrent Pharmaceuticals has added eight additional lots of losartan potassium tablets to its recall list. Losartan potassium is used to treat kidney disease in patients with diabetes and to control high blood pressure.

The US Food and Drug Administration said Thursday that Torrent Pharmaceuticals has added eight additional lots of losartan potassium tablets to its recall list. Losartan potassium is a drug used to control high blood pressure. It is also used to treat kidney disease in patients with diabetes.

This recall includes 30-, 90- and 1,000-count bottles of 100-milligram tablets; 30-, 90- and 1,000-count bottles of 50-milligram tablets; and 90-count bottles of 25-milligram tablets. Torrent is recalling only these particular losartan potassium tablets. Tests found that the drugs contained trace amounts of N-nitrosodiethylamine, or NDEA, that were above the interim acceptable intake level.

Aurobindo Pharma USA also recalled two lots of its valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrochlorothiazide combination tablets due to trace amounts of NDEA found in the valsartan ingredient in those pills. Those drugs are used to control high blood pressure and to treat heart failure.

N-nitrosodiethylamine is a suspected human and animal carcinogen that is used in gasoline and as a lubricant additive, according to the National Institutes of Health.

The ingredient in the tainted losartan potassium pills was made by Hetero Labs Ltd., based in India. That company has had manufacturing problems; it received a warning letter from the FDA in 2017 after an inspection found significant violations of good manufacturing practice regulations for finished pharmaceuticals.

The FDA started additional tests of these heart drugs, angiotensin II receptor blockers or ARBs, this summer after labs found that NDEA and another cancer-causing contaminant, NDMA, was accidentally added to some of these drugs.

The contaminants first showed up in drugs that contained valsartan, but subsequent tests have found them in others made by a Chinese company, Zhejiang Huahai Pharmaceutical Co. Ltd., and by Hetero Labs Ltd.

The FDA continues to test the ingredient for cancer-causing chemicals. It also keeps a list of drugs that have been recalled and a list of drugs that have not been recalled. The recalls have been expanded several times since the initial recall over the summer.

If your drug is on the recall list, the FDA suggests that you countinue taking it until your doctor or pharmacist provides a replacement. Because not all valsartan, losartan potassium and irbesartan drugs are involved in the recall, you might be able to switch to another company’s version.

It’s unclear exactly what the cancer risk is if you take the contaminated pills; the FDA believes that the risk is low.