After US, Singapore recalls BP drugs made with Hetero’s NMBA-tainted losartan

By PharmaCompass

2019-04-04

Impressions: 135 Article

Last month, PharmaCompass had reported on a third cancer-causing substance — N-nitroso-N-methyl-4-aminobutyric acid (NMBA) — the FDA had found in losartan potassium tablets that were made by India’s Hetero Labs and distributed by New Jersey-based Camber Pharmaceuticals. As a result, Camber Pharma had recalled 87 lots of losartan tablets.

Last week, there was news that Singapore’s Health Sciences Authority (HSA) is also recalling three brands of high blood pressure medicines containing the active ingredient losartan potassium, manufactured by Hetero Labs, after they were found it to contain higher than acceptable levels of NMBA. Around 137,000 patients in Singapore have been affected by the losartan recall, according to the Singapore government.

The current HSA recall includes three brands — Hyperten, Losagen and Losartas. The HSA had tested locally marketed losartan products for the presence of NMBA impurity. The exposure to nitrosamines, beyond permissible levels, over a long-term period may potentially increase the risk of cancer.

Losartan is an angiotensin receptor blocker drug commonly used to treat hypertension and control risks of serious heart ailments such as heart attacks and stroke. In June 2018, cancer-causing impurities were discovered in valsartan API manufactured by Chinese drugmaker Zhejiang Huahai. Since then, drug regulators across the world have stepped up recall of sartans tainted with three cancer-causing impurities.

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