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Concerns raised over recalled heart drug a year ago


A US inspector raised concerns with the Chinese manufacturer of a widely used heart drug more than a year before it was recalled for containing a probable cancer-causing chemical.

A Food and Drug Administration inspection in May 2017 found that the company, Zhejiang Huahai Pharmaceutical Co Ltd, ignored quality testing that showed unnamed drugs didn't meet US standards, according to an agency report posted online on Thursday. The company didn't look into the failures, and passing results were recorded instead, according to the report.

The blood-pressure medicine, called valsartan, was recalled last month. Zhejiang Huahai didn't respond to requests for comment.

"As soon as the FDA was alerted to problems, we initiated an investigation and coordinated with the manufacturers to take swift action to recall all of the affected products," FDA Commissioner Scott Gottlieb said in an email statement.

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Sarah Peddicord, a spokeswoman for the FDA, declined to say when the agency was alerted to the problems.

The FDA on Thursday also added valsartan made by India-based Hetero Labs Ltd to the recall. The chemical in the Hetero valsartan exceeds acceptable levels, though is generally lower than levels found in the active ingredient made by Zhejiang Huahai. The Hetero products are labelled under Camber Pharmaceuticals Inc. An FDA inspection uncovered problems at Hetero in 2016.

Hetero's manufacturing process is similar to Zhejiang Huahai's, and the FDA has contacted other valsartan makers to determine if their manufacturing processes are at risk.

The FDA has found issues related to drug manufacturing in China and India that have raised concerns about the safety of those pharmaceuticals. More than 80 per cent of the ingredients used to make US-consumed drugs are produced outside of the country, according to the agency. China, along with India, accounts for most of the raw ingredients in drugs consumed in the US.

The FDA redacted from the Zhejiang Huahai report the names of the drugs that failed quality testing, but the report indicates that the tests were on active pharmaceutical ingredients. Zhejiang Huahai made active ingredients for the drug valsartan, which treats heart failure and high blood pressure and is sold by Teva Pharmaceutical Industries Ltd and Prinston Pharmaceutical Inc. Those companies recalled the products last month.

The valsartan that was recalled contained a chemical called NDMA, which the US Environmental Protection Agency considers a probable human carcinogen. Based on manufacturing records, NDMA may have been in the impure valsartan for as long as four years. The FDA is testing samples of valsartan to determine the extent of the contamination. WP

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