FDA Warns of 2nd Cancer-Causing Chemical in Recalled Valsartan

Published on September 14, 2018 by Sandy Liebhard

A new cancer-causing chemical has been detected in some lots of valsartan, a generic heart and blood pressure drug that is already at the center of a massive recall.

NDEA Detected in Torrent Pharmaceutical’s Recalled Valsartan Tablets

According to a statement issued by the U.S. Food & Drug Administration (FDA) on September 13^th, N-Nitrosodiethylamine (NDEA) was detected in 3 lots of valsartan tablets distributed by Torrent Pharmaceuticals.

NDEA is a known cause of cancer in animals, and is suspected as a cause of cancer in humans.

The medication lots were included in the Torrent valsartan recall announced on August 28^th. That recall was among those issued after N-Nitrosodimethylamine (NDMA) – also considered a probable human carcinogen – was detected in active ingredient used to manufacture the drugs.

The active ingredient was sourced from Zhejiang Huahai Pharmaceuticals, a Chinese manufacturer.

“As we continue to investigate the root cause of the impurities found in products that contain valsartan, our scientists are testing these products to better understand these impurities and to ensure they’re not present in other products,” FDA Commissioner Scott Gottlieb said. “We’re also taking steps to make sure we’re providing stringent oversight of manufacturing processes to reduce the likelihood that impurities could be introduced into other products.”

Valsartan Recalls Announced in 22 Countries

In recent months, valsartan recalls have been announced in the United States and 21 other countries for NDMA-contaminated drugs. More than 2,300 drug batches have been recalled by 5 generic drug makers and multiple distributors.

The presence of NDMA and NDEA is often the result of chemical reactions that occur during the production process.  The FDA suspects that a change made to Zhejiang Huahai Pharmaceuticals’ manufacturing methods in 2014 could account for the ongoing contamination issues.

Not all valsartan products currently on the market are affected by these recalls. The FDA has posted an updated  list of products included in the valsartan recall, as well as a list of products not included in the recall.

Patients should not stop taking their medication even if their valsartan is included in the recall, as doing so could result in serious health consequences. Rather, they should contact their doctor to arrange for an alternative treatment.

Consumers with questions about the valsartan recall can contact the FDA’s dedicated hotline at 855-543-378. The number, which is being manned by a group of pharmacists and nurses, has received more than 6,000 inquiries since the first recall was announced.