Regulators find second cancer-linked chemical in recalled drug

Sep 17, 2018

A closer inspection of valsartan, a commonly used blood pressure medication, has uncovered traces of a second toxin.

The medication, made by China-based Zhejiang Huahai Pharmaceutical, was already recalled in July after regulators found traces of N-nitrosodimethylamine (NDMA), a chemical that has been deemed a potential carcinogen for humans. Now, regulators in North American and Europe have reported the presence of N-nitrosodiethlamine (NDEA), another chemical linked to cancer. Both chemicals are byproducts of the manufacturing process for the medication.

According to estimates by European regulators, a detected presence of the toxins could add one additional cancer case per 5,000 patients taking the highest dose of the valsartan for seven years. 

The first recall focused on medications made after 2012, but the latest contamination was detected in treatments produced before 2012 — a finding that is likely to widen the recall efforts.

The active recall has already affected over 50 companies who use valsartan in combination products.

The regulatory bodies said they will continue to investigate the contamination and work to remove any tainted products from the market. 

Read the full Reuters report.

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