Irbesartan lots recalled over likely carcinogen: FDA

by Kim Boateng Last updated on April 20th, 2019,

A drug company has recalled more irbesartan blood pressure medication after discovering a potential human carcinogen.

Prinston Pharmaceutical, doing business as Solco Healthcare, has voluntarily recalled of eight more lots of irbesartan blood pressure medication after detecting trace amounts of impurity in an active pharmaceutical ingredient, the Food and Drug Administration announced Friday.

The ingredient in question contains N-nitrosodiethylamine (NDEA), “a substance that occurs nationally in certain foods, drinking water, air pollution, and industrial processes” and has been classified by the International Agency for Research on Cancer as a probable human carcinogen.

NDEA was manufactured by a factory in China called Zhejiang Huahai Pharmaceuticals, which has been linked to several recalls of blood pressure drugs dating back to July.

Lots of other blood pressure and heart medications such as valsartan, losartan, amlopidine and hydrochlorothiazide have also been recalled since July.

The FDA issued an import alert in September to block products made at the China plant from entering America and issued a warning letter in November about challenges including impurity control.

Hetero Labs, another factory in India, has also been linked to multiple recalls.

Prinston will only be recalling lots of irbesartan-containing products that contain NDEA above the acceptable intake levels released by the FDA.

“Patients who are on Irbesartan should continue taking their medication, until their pharmacist provides a replacement, or their doctor prescribes a different medication that treats the same condition as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment,” the FDA statement said.

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