Business

Global health regulators find second toxin in

common heart drug
FRANKFURT/BENGALURU: European and North American regulators have found a second
toxin that may cause cancer in humans in a commonly used blood pressure drug made by
Chinese firm Zhejiang Huahai Pharmaceutical.

Health regulators in the European Union, United States and Canada had already recalled drugs
made with the company's active pharmaceutical ingredient valsartan after finding traces of the
chemical N-nitrosodimethylamine (NDMA), considered a potential human carcinogen, in the
medicine.

On Thursday (Sep 13), the European Medicines Agency (EMA) said a different chemical, N-
nitrosodiethylamine (NDEA), had been detected in products produced before 2012. The US Food
and Drug Administration (FDA) also said it had detected the chemical in the recalled drug.

Valsartan is a generic drug that had global sales of 10.4 billion pills last year, including
combination products, according to healthcare data consultancy IQVIA. People with high blood
pressure typically take one pill daily, and others take two pills if they have congestive heart
failure, in which the heart fails to pump adequate blood.

More than 50 companies around the world making finished tablets from the tainted valsartan
have recalled products in recent weeks, according to a Reuters analysis of records at national
medicines agencies. They include major generics manufacturers such as Teva Pharmaceutical
Industries, Ranbaxy Laboratories and Sandoz.

Based on the average NDMA impurity of 60 parts per million (ppm) detected at Huahai, the
EMA has said there could be one additional case of cancer in every 5,000 people taking the
highest dose for seven years.

The valsartan recalls have focused on products produced after 2012, when there was a change in
the Chinese company's manufacturing process. Now, after finding the second toxin, the EMA is
looking at product made before 2012 as well. Both chemicals are a by-product of the
manufacturing process.

"In addition to NDMA, EMA is assessing the impact of a related substance, N-

nitrosodiethylamine (NDEA), which has been detected in valsartan made by Zhejiang Huahai,
using its previous manufacturing process before changes were introduced in 2012," it said in a
statement on Thursday.

"Data on levels of NDEA are currently very limited, and EMA will provide further information
on whether its presence impacts the risk assessment once more information becomes available."
The FDA said the latest testing of products found NDEA in three lots of valsartan produced by
Indian firm Torrent Pharmaceuticals Ltd that were part of its broad valsartan recall in August
related to NDMA.

Torrent makes valsartan tablets using active pharmaceutical ingredients from Zhejiang Huahai.

The FDA said it is continuing to test all products that contain valsartan for NDEA and related
impurities, and will work with companies to ensure that all affected products are removed from
the market, if they have not already been recalled.

Separately, Canada's health watchdog said it has also found NDEA, but noted all drugs
containing valsartan manufactured by Zhejiang Huahai had already been recalled in Canada after
the first impurity was identified in the summer.

Zhejiang Huahai did not respond to requests for comment.

A Torrent representative did not immediately respond to a request for comment.

Source: Reuters/mz
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regulators-find-second-toxin-in-common-heart-drug-10728788