FDA Announces Valsartan Recall

In July 2018, the U.S. Food and Drug Administration (FDA) issued a recall of a number pharmaceutical drugs containing valsartan used to treat hypertension (high blood pressure) and heart failure due to the increased risk of certain cancers associated with NDMA. Not all drugs containing valsartan were named in the recall.

The following were named in the recall:

  • Major Pharmaceuticals valsartan products
  • Solco Healthcare valsartan products
  • Teva Pharmaceuticals Industries Ltd. valsartan products
  • Solco Healthcare valsartan/HCTZ products
  • Teva Pharmaceuticals Industries Ltd. valsartan/HCTZ products

“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.  See here for the recall.

The FDA issued a press release along with the recall announcement – “The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured,” the FDA release said.

The FDA is now conducting a full-length investigation into the safety of the recalled products.

The FDA stresses the importance that patients DO NOT stop taking the recalled products altogether – the danger of abruptly discontinuing use of this medication greatly outweighs the risks associated with short-term NDMA exposure – patients should rather contact their healthcare provider right away to discuss alternative medication options.

The FDA followed suit of 22 other countries that had previously recalled valsartan products.

NDMA Found in Valsartan

Chinese manufacturer Zhejiang Huahai Pharmaceutical first discovered that the generic valsartan products =the company was producing contained impurities, including N-nitrosodimethylamine (NDMA).

Zhejiang Huahai Pharmaceutical supplied these generic drugs containing NDMA to US-based pharmaceutical companies Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd. These companies then processed and distributed the drugs to the US market.

What is N-nitrosodimethylamine (NDMA)?

NDMA is an organic chemical compound that has been labeled as a probable human carcinogen, according to the International Agency for Research on Cancer (IARC).

NDMA is found in a variety of products ranging from lubricants and softeners to rocket fuel.

NDMA can be produced through chemical reactions that occur in the manufacturing process.

NDMA is the byproduct of the manufacturing of certain pesticides, fish processing, and the production of rubber tires.

NDMA can also be found naturally, in trace amounts in certain foods. NDMA is released in these foods through chemical reactions during the food preparation process. For example, NDMA can be produced by grilling, browning, and salting of certain meats.

Studies on animals have shown NDMA to be a carcinogen, causing cancerous tumors to form on the liver, kidney, and respiratory tract.

Liver cancer, gastric cancer, colorectal cancer, kidney cancer, lung cancer, and nasal cancer have all been associated with NDMA, but it appears to be a universal carcinogen, meaning it has the potential to cause cancer in almost all organs. For these reasons, NDMA has been labeled a probable human carcinogen.

NMDA exposure has also been associated with non-cancerous liver damage, according to the US Department of Health and Human Services.

If you or a loved one has been diagnosed with liver cancer, gastric cancer, colorectal cancer and/or kidney cancer subsequent to your Valsartan use, contact a skilled and experienced drug attorney today.