FDA Recalls Even More Drugs Which Use Valsartan, Citing Cancer Risk

In July of 2018, the Food & Drug Administration (FDA) issued a recall notice for a number of drugs containing valsartan, a medication used in the treatment of high blood pressure and congestive heart failure. The batches, which had been manufactured in China, contained traces of N-nitrosodimethylamine (NDMA) – a cancer-causing carcinogen. In early August, the FDA updated its list of recalled valsartan medications (as well as a list of products not included in the recall), as more information became available.

On August 9, 2018, the FDA expanded the list of recalled valsartan drugs for the second time, to include batches manufactured in India. The U.S. is the 23^rd country to issue a recall of the product.

What is NDMA, and why is it dangerous?

NDMA is, according to the Environmental Protection Agency, a “semivolatile organic chemical that forms in both industrial and natural processes.” In the U.S., this chemical not intentionally produced for commercial purposes (though it used to be a component of rocket fuel); it is, however still produced for research purposes.

One of the main concerns with NDMA, however, is how easily it can mix into water and become part of whatever solution exists. This “miscibility,” as the EPA calls it, is excellent for creating rocket fuel; it is less excellent when it comes to our drinking water, where it can quickly contaminate the supply. It is classified as a carcinogen: “a substance capable of causing cancer in living tissue.”

As of now, no one is saying definitively what the cancer risk is – only that there is a risk. Dr. Erin Michos, who is a Johns Hopkins University associate professor and their associate director of preventive cardiology, told CNN “the dose makes the poison…. It is a toxin that can affect the liver and cause liver fibrosis or scarring and liver tumors in rats. So it is assumed to be toxic to humans, as well.”

If that explanation sounds a bit flimsy, know this: Dr. Michos also told CNN “I definitely am switching my patients off this medication if supplied by one of the affected companies.“

How did contaminated valsartan drugs make it to market in the first place?

The answer is, no one is saying.

In July, Novartis (which developed the drug originally) issued a recall of the drugs in Europe and the UK, claiming the drugs failed to meet quality standards. During a series of tests, Novartis discovered that the drugs which came “from an external supplier contained an impurity. The European Medicines Agency reviewed medicines from the supplier, Zhejiang Huahai Pharmaceuticals in Linhai, China. The agency said the impurity is ‘a result of a change in the manufacturing process.’”

Regarding the most recent recall, it was found that Hetero Labs Limited in India (which manufactures drugs for Camber) was following a similar process as Zhejiang Huahai Pharmaceuticals.

Had the proper testing been done before these defective drugs were allowed to reach patients, someone may have caught the cancer-linked impurity.

Companies affected by the recalls

At this point, there are 55 valsartan products on the recall list. Not all products which contain valsartan have been contaminated, so not all products have been recalled. If you do use a medication that has been affected by the recall, there are alternative medications on the market that can be used until new, clean batches have been manufactured and distributed.

The manufacturing companies and affected products are:

Major Pharmaceuticals (part of Teva Pharmaceuticals)

• Valsartan 80 mg and 160mg Tablets

Actavis (part of Teva Pharmaceuticals USA)

• Valsartan 40mg Tablets, 30 count and 90 count bottles
• Valsartan 80mg Tablets, 90 count and 1000 count bottles
• Valsartan 160mg Tablets, 90 count and 1000 count bottles
• Valsartan 160mg Tablets, 1000 count bottle
• Valsartan 320mg Tablets, 90 count and 500 count bottles
• Valsartan and Hydrochlorothiazide (HCTZ) 80mg/12.5mg Tablets, 90 count bottle
• Valsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablets, 90 count bottle
• Valsartan and Hydrochlorothiazide (HCTZ) 160mg/25mg Tablets, 90 count bottle
• Valsartan and Hydrochlorothiazide (HCTZ) 320mg/12.5mg Tablets, 90 count bottle
• Valsartan and Hydrochlorothiazide (HCTZ) 320mg/25mg Tablets, 90 count bottle

AvKARE

• Valsartan and Hydrochlorthiazide (HCTZ) 80mg/12.5mg Tablets, 90 count bottle
• Valsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablets, 90 count bottle
• Valsartan and Hydrochlorothiazide (HCTZ) 320mg/12.5mg Tablets, 90 count bottle
• Valsartan and Hydrochlorothizaide (HCTZ) 160mg/25mg Tablets, 90 count bottle
• Valsartan and Hydrochlorothiazide (HCTZ) 320mg/25mg Tablet, 90 count bottle

Remedy Repack

• Valsartan and Hydrochlorothiazide (HCTZ) 320mg/12.5mg Tablet, 90 count bottle
• Valsartan and Hydrochlorothiazide 160mg/12.5mg Tablets, 90 count bottle

A-S Medication Solutions LLC

• Valsartan 80mg and 160mg Tablets
• Valsartan 160mg Tablets
• Valsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablets
• Valsartan and Hydrochlorothiazide (HCTZ) 320mg/25mg Tablets

Bryant Ranch Prepack Inc.

• Valsartan 80 mg Tablets, 28 count, 60 count and 90 count bottles
• Valsartan 320 mg Tablets, 28 count, 30 count, and 90 count bottles

H J Harkins Company Inc. dba Pharma Pac

• Valsartan 160mg Tablets, 90 count bottle

Proficient Rx LP

• Valsartan and Hydrochlorothiazide (HCTZ) 320mg/12.5mg Tablets, 90 count bottle

Northwind Pharmaceuticals

• Valsartan 80mg Tablets, 30 count bottle
• Valsartan 160mg Tablets
• Valsartan 320mg Tablets, 30 count bottle
• Valsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablets

Camber Pharmaceuticals, Inc.

• Valsartan 40mg Tablets, 30 count bottle
• Valsartan 80mg Tablets, 90 count bottle
• Valsartan 160mg Tablets, 90 count bottle
• Valsartan 320mg Tablets, 90 count bottle

NuCare Pharmaceuticals Inc.

• Valsartan and Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablets, 90 count bottle
• Valsartan and Hydrochlorothiazide (HCTZ) 160mg/25mg Tablets, 30 count bottle
• Valsartan and Hydrochlorothiazide (HCTZ) 320mg/25mg Tablets, 30 count bottle

You can access the complete information here, including lot numbers and expiration dates.

If you have questions about defective drug recalls, or were injured or made ill by the defective valsartan drugs, McGowan, Hood, Felder & Phillips, LLC may be able to help. Our medical product liability lawyers have helped clients make successful claims for compensation after they sustained injuries. To learn more about our services, or to schedule a free initial consultation, please call 803-327-7800 or fill out our contact form.