Losartan Recall Triggered by Discovery of Third Cancer-Causing Chemical

Published on March 4, 2019 by Sandy Liebhard

The U.S. Food & Drug Administration (FDA) announced a new losartan recall last week, after tests detect a third cancer-causing chemical in foreign-sourced generic tablets.

This latest recall involves nearly 90 lots of Losartan potassium made by Hetero Labs in India and distributed by Camber Pharmaceuticals. According to the FDA, the recalled losartan tablets may contain trace amounts N-Nitroso N-Methyl 4-amino butyric acid (NMBA), a probable carcinogen.

The affected drugs are packed in 30, 90, 500, and 1000 count bottles with the following NCD numbers: Losartan 25 mg 31722-700-90, 31722-700-05, 31722-700-10; Losartan 50 mg 31722-701-30, 31722-701-90, 31722-70-10; and Losartan 100 mg 31722-702-30, 31722-702-90, and 31722-702-10.

Losartan Recall Background

Losartan is an angiotensin II receptor blocker (ARB) used to treat high blood pressure and heart failure.

This is the first time tests have detected NMBA in a generic ARB. However, last year, the presence of two other probable carcinogens — N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) – forced numerous generic drug makers to recall:

• Amlodipine in combination with valsartan
• Valsartan HCTZ
• Single-ingredient irbesartan
• Irbesartan HCTZ
• Single-ingredient losartan
• Amlodipine in combination with losartan
• Losartan HCTZ

“Our ongoing effort has determined that the impurities may be generated by specific chemical reactions in the manufacturing process of the drug’s active pharmaceutical ingredients,” said FDA Commissioner Scott Gottlieb, M.D., in a statement.

Hetero Pharmaceuticals and China-based Zhejiang Huahai Pharmaceutical Co., Ltd. supplied the active pharmaceutical ingredient behind previous valsartan, irbesartan, and losartan recalls.

Consumers should contact their pharmacy to determine if their ARB is included in one of these recalls. They can also check regularly-updated lists of recalled  valsartan products, losartan medications, and irbesartan products  posted on the FDA’s website.

Patients with a recalled ARB should not stop taking the drug until they have obtained a replacement, as doing so could lead to life-threatening heart or blood pressure events.

Valsartan Lawsuits Move Forward in Federal Court

More than a dozen lawsuits are currently pending in U.S. courts that relate to recent valsartan recalls.

Most of these claims seek class action status on behalf of consumers who purchased worthless and dangerous medications. However, a growing number of indivudal valsartan lawsuits claim that tainted drugs caused a patient’s cancer.

Earlier this month, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all federally-filed valsartan lawsuits before a single judge in New Jersey for coordinated pretrial proceedings. At some point, the JPML could expand the litigation to include lawsuits stemming from the irbesartan or losartan recall.