KJ McElrath  |  June 29, 2019

Category: Legal News

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White pills on whiteA number of valsartan manufacturers have had their products recalled over fears of contamination by carcinogenic industrial chemicals.

The contamination affects a number of other blood pressure medications in the same class – and while these prescription medications are all manufactured and sold by different pharmaceutical companies, the source of all of the valsartan contamination has been traced to two facilities – one in China and the other in India – where the active ingredient is produced.

Although the chances that a patient taking valsartan or a similar drug will get cancer is small, the fact that these medications contain a poisonous substance at all has raised grave concerns about quality control and consumer safety.

What is Valsartan?

Sold under the brand Diovan, valsartan is a prescription medication commonly used as a first-line treatment for hypertension, or high blood pressure. Valsartan and other medications of this class (which also includes losartan and irbesartan) are classified as “angiotensin II receptor” antagonists.

Angiotensin is a hormone that causes blood vessels to constrict; valsartan and similar drugs work by blocking the cellular receivers (“receptors”) that get signals from angiotensin. This mechanism of action is somewhat metaphorical to putting selective earplugs into a person’s ear, rendering them unable to hear specific instructions given to them.

Valsartan has been available to patients since 1996. As of 2018, over 8 million patients had been given prescriptions for this medication.

What Carcinogens Have Valsartan Manufacturers Discovered?

There are three similar chemical compounds that Valsartan manufacturers have identified in their products. These are N-nitrosodiethylamine (NDEA), N-nitrosodimethylamine (NDMA) and N-Methylnitrosobutyric acid (NMBA).

NDEA is essentially an industrial lubricant that is also used in the production of aviation fuel. NDMA is a waste product associated with a number of different industrial processes, including the manufacture of rocket fuel, while NMBA is one of the toxins found in tobacco products.

Where Did These Chemicals Come From?

Valsartan manufacturers have two sources for the active ingredient. One of them was traced to Zhejiang Huahai Pharmaceuticals, a facility in China where the active ingredient is produced. According to PharmaTech.com, the contamination was apparently the result of changes made in the manufacturing process in 2012, which was intended to streamline the operation while reducing waste and increasing yield.

The other source of contamination was Hetero Labs, which is located in India. Significantly, this company received a warning letter from the FDA in 2017 following an investigation finding violations of good manufacturing practices and regulatory violations.

According to the letter, Hetero Labs failed to have “an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality.”

Which Valsartan Manufacturers Have Recalled Their Products?

Pharmaceutical companies producing valsartan that have been affected by the recall include:

  • Aurobindo
  • Camber
  • Mylan
  • Teva (Actavis)
  • Torrent

Similar drugs (losartan, irbesartan) manufactured by Sandoz and sold in generic form by Sciegen Pharmaceuticals have also been recalled. A comprehensive list of valsartan manufacturers and specific products that have been subject to recall is available at the FDA website.

If you developed cancer or severe liver damage after taking valsartan, you may benefit from joining a free valsartan lawsuit investigation. Fill out the FREE form on this page for more information.

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