Blood pressure drug Losartan recalled

Faith Castro
March 5, 2019

N-Nitroso-N-methyl-4-aminobutyric acid or NMBA was identified by the FDA in a news release announcing a voluntary recall by Camber Pharmaceuticals Inc. after it had detected trace amounts of the impurity in the drugs, though the company was not aware of any adverse effects from the recalled batch.

That impurity is N-nitrosodiethylamine (NDEA), which is classified as a "probable human carcinogen". The active drug ingredient was made at Hetero Labs Restricted in India, one in all two overseas drug factories linked to repeated blood treatment recollects since final July.

Last Friday, the FDA announced Macleods Pharmaceuticals Limited recalled one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg after NDEA was found in the medication.

A man has his blood pressure checked at the Remote Area Medical Clinic in Wise, Virginia, U.S., July 22, 2017. That said, any presence of such impurities in drug products is not acceptable.

The FDA has said it thinks the potential carcinogens, known as nitrosamine impurities, are a result of the manufacturing processes the companies used. 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.

"We are making important strides at understanding how these impurities form and we are continuing to examine if nitrosamine impurities may also arise during the manufacture of other ARB drug products", Gottlieb wrote.

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Manufacturers are compelled to report impurities, for example, and the agency inspects factories on a risk-prioritized basis.

"Before they found this particular compound, they didn't even know there could be a chemical reaction that could produce the compound", she said. Other people are getting their prescriptions changed.

More information about the losartan recall can be found on the FDA website.

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. Patients also are encouraged to talk to their doctor or pharmacist as soon as possible.

Here's a list of the Torrent Pharmaceuticals products being recalled.

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