As more sartan recalls are announced, US to see further shortages of BP medicines

By PharmaCompass

2019-01-31

Impressions: 89 Article

We have been covering the sartan issue since July of last year, when the US Food and Drug and Administration (FDA) was informed by Chinese manufacturer Zhejiang Huahai Pharmaceuticals Co (Huahai) that the valsartan it produced contained certain impurities that are carcinogenic. This led to a worldwide recall of not just drugs that contained valsartan, but other sartans as well, such as losartan and irbesartan.

Sartans belong to a class of widely used medicines for treating high blood pressure called angiotensin II receptor blockers, or ARBs.

Six months on, sartans are still being recalled. The most recent recall was announced just a few days back. On January 22, Torrent Pharmaceuticals Limited said it is expanding its voluntary recall of losartan potassium tablets and losartan potassium and hydrochlorothiazide tablets in the US due to the detection of trace amounts of an impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected is N-nitrosodiethylamine (NDEA), a probable human carcinogen.

Similarly, India’s Aurobindo Pharma is recalling 1,62,301 bottles of amlodipine and valsartan tablets, 3,12,095 bottles of valsartan and hydrochlorothiazide tablets and 20,604 bottles of valsartan tablets in the US, as the FDA confirmed the presence of NDEA.

As a result, the FDA has cautioned that these recalls can lead to additional shortages of BP drugs in the United States.

The FDA Commissioner Scott Gottlieb and the agency’s director of the Center for Drug Evaluation and Research Janet Woodcock issued a statement on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues.

At least two million people around the world have been exposed to cancer-causing chemicals in the tainted BP drugs. More than one million of those affected are in the US, which heavily relies on China for drug ingredients.

The agency said the impurities “may be generated when specific chemicals and reaction conditions are present in the manufacturing process” and “may also result from the reuse of materials, such as solvents.” The reuse of solvents is an accepted practice in the industry, but manufacturers are generally expected to ensure that reused materials meet certain safety standards.

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