The United States Food and Drug Administration (FDA) found an additional cancer-causing agent into of heart failure and blood pressure medication. The FDA found that three lots of the valsartan drugs, offered by Torrent Pharmaceuticals, had what is known as NDEA.
NDEA, or N-Nitrosodiethylamine, has been found to be carcinogenic in animals and has mutagenic properties. The ingredient is used in lubricant and gasoline additives.
The announcement is another blow for Torrent, which is already in the middle of a recall for their valsartan drugs. The original recall found traces of NDMA contamination. NDMA is also an impurity that could cause cancer.
Initial investigations into the matter by the FDA suggest that both of the batches of the drugs which contained NDEA and NDMA were manufactured in China by Zhejiang Huahai Pharmaceuticals.
Zhejiang Huahai Pharmaceuticals reportedly found NDEA in several batches of the commonly prescribed medications.
“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,” states FDA Commissioner Scott Gottlieb.
The FDA claims that they will continue to update the public with the latest information relating to the contamination and their investigation.
Investigators are still trying to determine how the impurities got into the medication. The FDA has made the list of impacted drugs available for the public to view.
FDA officials caution those that are on valsartan drugs that have been impacted to continue taking their medication until a doctor prescribes an alternative option. Not all of the valsartan products were found to contain NDMA or NDEA.
Chinese production has come into question following the report, with many people questioning if other products manufactured in China have been tainted.
The FDA suggests a change in how the medication was manufactured is likely the cause for the impurities.
