Torrent Pharmaceuticals has expanded its blood pressure drug recall to include eight additional lots of generic losartan tablets.
According to the company, the losartan tablets could be contaminated with N-nitrosodiethylamine (NDEA), a known animal and suspected human carcinogen.
Torrent recalled two losartan lots in December, bringing the total number of recalled lots to 10.
Losartan is the generic equivalent of an angiotensin receptor blocker (ARB) sold under the brand name Cozaar. The medication is indicated to treat:
The U.S. Food & Drug Administration (FDA) has advised patients with recalled losartan tablets to contact their doctor or pharmacist to arrange for an alternative medication.
However, its important that patients continue taking losartan until obtain a replacement, as stopping treatment entirely could result in serious adverse health consequences.
The active pharmaceutical (API) ingredient for Torrent’s losartan was manufactured by India-based Hetero Labs. The company is one of two overseas drug makers linked to blood pressure drug recalls in recent months.
In June, China-based Zhejiang Huahai Pharmaceuticals informed regulators throughout the world that it valsartan API was contaminated with N-nitrosodimethylamine, or NDMA, a probable human carcinogen.
Hetero Labs disclosed that its valsartan API was contaminated with NDMA in August, while the FDA announced that testing had detected NDEA in the company’s losartan API the following month. The impurity was detected in generic versions of irbesartan (brand name Avapro) in November and first turned up in generic losartan tablets in December.
In addition to single-ingredient valsartan, losartan, and irbesartan, recalls have also been announced for generic versions of:
However, neither amlodipine nor HCTZ is currently under recall by itself.
Along with Torrent Pharmaceuticals, the recalled medications were marketed by Aurobindo Pharma USA, Teva Pharmaceuticals, Mylan Pharmaceuticals, Sandoz, ScieGen Pharmaceuticals, Camber Pharmaceuticals, Major Pharmaceuticals, and Prinston Pharmaceuticals, among others.
According to the FDA, NDEA and NDMA were likely byproducts of similar production methods utilized by Hetero Labs and Zhejiang Huahai Pharmaceuticals.
In November, the FDA issued a Warning Letter to Zhejiang Huahai Pharmaceuticals, after an agency inspection turned up numerous problems at its manufacturing plant in China. What’s more, the company subject to an import alert that prohibits its API and finished drug products from entering the United States.
In recent months, more than a dozen valsartan lawsuits have been filed on behalf of consumers affected by the blood pressure drug recall. While the majority are class action complaints that seek refunds for valsartan purchases, several allege that the tainted medication caused users to develop kidney cancer or other cancers.
On January 31st, the U.S. Judicial Panel on Multidistrict Litigation will hear Oral Arguments on a petition to centralize all federally-filed valsartan lawsuits in a single U.S. District Court.