The U.S. Food and Drug Administration warns that the recall of valsartan heart drugs might be expanded to include other products.

In July, the FDA issued a recall of certain lots of generic the blood pressure medication valsartan after the active ingredient made in China was found to be tainted with NDMA (N-nitrosodimethylamine) — a probable carcinogen. The NDMA was found in the valsartan made by Zhejiang Huahai (ZHP) after the company had changed its manufacturing process.

The FDA says more than half of all valsartan heart drugs on the market are under recall. Europe and Canada purportedly have issued their own similar recalls.

Valsartan is the generic type of Diovan, which is made by Novartis International AG. Diovan and several generic versions made by companies other than the ones listed below are not part of the valsartan recall.

Among the valsartan heart drugs under recall are those distributed by the following companies:

• Teva Pharmaceuticals, labeled as either Major Pharmaceuticals or Actavis
• AvKare
• Prinston Pharmaceutical In. labeled as Solco Healthcare LLC
• RemedyRepack Inc.
• A-S Medication Solutions LLC
• Bryant Ranch Prepack Inc.
• HJ Harkins Company Inc dba Pharma Pac
• Northwind Pharmaceuticals
• Hetero Labs, Inc. labeled as Camber Pharmaceuticals, Inc.
• NuCare Pharmaceuticals Inc.
• Preferred Pharmaceuticals, Inc.
• Torrent Pharmaceuticals Unlimited

The medication itself is not a threat, but the contaminated medications could cause serious side effects because NDMA could place patients at a great risk for cancer.

The FDA released a statement indicating that if 8,000 patients took the highest valsartan dose from NDMA-tainted medications every day for four years, there might be one additional cancer case over the lifetimes of the 8,000 patients beyond the current average rate of cancer among Americans.

All Varsartan Heart Drugs Being Tested

The FDA was alarmed to see that NDMA was a by-product of the manufacturing of the active ingredient in the drug. As a result, the FDA is broadening its investigation to examine all drugs in the angiotensin II receptor blocker class. The FDA explained that the synthesis of other angiotensin II receptor blocker medications can be very similar to that of valsartan.

The FDA’s statement said, “Based on information provided regarding ZHP’s manufacturing processes, we believed (but did not have proof) that the impurity resulted from changes that ZHP made to the manufacturing process for its API [active primary ingredient].”

“Because it was not anticipated that NDMA would occur at these levels in the manufacturing of the valsartan API, manufacturers would not have been testing for it,” continued the FDA’s statement.

The Environmental Protection Agency (EPA) describes NDMA as a yellow liquid that is nearly odorless with a sweet taste. NDMA was previously used in the production of rocket fuel and antioxidants. NDMA also has been detected as a byproduct of waste water disinfection.

According to the EPA, “NDMA is a drinking water contaminant of concern because of its miscibility with water, as well as its carcinogenicity and toxicity.”

The FDA released a statement indicating that the agency is working to make sure valsartan patients in the U.S. have an “adequate supply of unaffected medications.”

Patients who have been taking valsartan heart drugs covered by the recall and who have been diagnosed with cancer may not realize the drug and their cancer are related because cancer is related to the NDMA contamination, not the medication itself.

If you have been diagnosed with cancer after taking valsartan heart drugs, you could be eligible to participate in this lawsuit investigation.