The Link Between NDMA and Valsartan and Why It Matters

NDMA and Valsartan: What You Should Know

NDMA, or
N-Nitrosodimethylamine, is a byproduct of both industrial and natural processes, and therefore
can be found in the environment naturally or as a result of various manufacturing
processes. The chemical has been classified as a “probable human
carcinogen” by the EPA. The EPA Technical Fact Sheet on NDMA describes
it as both carcinogenic and toxic. NDMA was previously utilized intentionally
in the production of rocket fuel, antioxidants, and copolymers, but is
no longer used in the United States, with the exception of research purposes.
However, NDMA may be unintentionally produced during the manufacturing
of pesticides, rubber and tires, dye, and surfactants.

Notably, NDMA can be an unintended byproduct in the chlorination of water
at wastewater treatment plants, which raises significant concern that
NDMA could be present as a drinking water contaminant. The chemical is
miscible in water and highly mobile in soil, which means it has the potential
to leach into ground water when it is present in the environment, whether
naturally or as a byproduct of manufacturing processes. For example, at
rocket engine testing facilities in California that previously utilized
NDMA in their manufacturing processes, high-concentrations of the chemical
were found both in groundwater and in drinking water wells on site. At
least 15 states have established guidelines limiting the amount of NDMA
that can be present in groundwater and drinking water. Water standards
are generally designed to keep the cancer risk to one case in every million
or 100,000 people, based upon a lifetime exposure to a substance.

NDMA may also be present in small amounts in smoked or cured meats and
fish, foods that contain alkylamines, malt beverages such as beer or whiskey,
some toiletry and cosmetic products, and cigarette smoke. This is especially
concerning given the toxic and carcinogenic properties of the chemical.
A 1999 study published in the International Journal of Cancer found that
people who ate food contaminated with NDMA had a significantly increased
risk of developing colorectal cancer.

Per the EPA, potential symptoms of overexposure of NDMA may include headache,
fever, nausea, jaundice, vomiting, abdominal cramps, enlarged liver, or
dizziness. Overexposure can lead to reduced function of the liver, kidney,
and lungs, or damage to these organs. Animal studies found that NDMA caused
tumors of the liver, respiratory tract, kidney, and blood vessels.

How does NDMA relate to valsartan-containing medications?

You may be wondering, “how does this chemical relate to valsartan
medications?”. Medications containing valsartan are widely-prescribed
in the United States and around the world for the treatment of high blood
pressure and heart failure. In July 2018, the FDA followed 22 other countries
in recalling certain valsartan-containing medications due to concern that
the medications were contaminated with startling levels of NDMA. The FDA
recall involves more than half of all valsartan prescriptions in the United
States, potentially affecting thousands of patients.

Early research shows that the contamination may date as far back as 2012,
the same year the patent on this type of medication expired. The levels
of NDMA contained in some valsartan medications may result in an increased
cancer risk as high as 1 in 8000 individuals.

The medications included in the recall as of September 13, 2018 include:

  • Valsartan
  • Valsartan and hydrochlorothiazide (HCTZ)
  • Amlodipine, valsartan and hydrochlorothiazide (HCTZ)
  • Amlodipine and valsartan

The recall of these medications is specific to the following manufacturers:

  • Teva Pharmaceuticals labeled as Major Pharmaceuticals
  • Prinston Pharmaceutical Inc. labeled as Solco Healthcare LLC
  • Teva Pharmaceuticals USA labeled as Actavis
  • AvKARE (Teva/Actavis)
  • RemedyRepack Inc. (Prinston/Solco)
  • A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco)
  • Bryan Ranch Prepack, Inc. (Teva/Actavis)
  • HJ Harkins Company Inc. dba Pharma Pac (Prinston/Solco)
  • Northwind Pharmaceuticals (Teva/Actavis)
  • Hetero Labs, Inc. labeled as Camber Pharmaceuticals Inc.
  • NuCare Pharmaceuticals Inc. (Prinston/Solco)
  • RemedyRepack Inc. (Hetero/Camber)
  • AvKARE (Hetero/Camber)
  • Preferred Pharmaceuticals, Inc. (Hetero/Camber)
  • Torrent Pharmaceuticals Limited
  • RemedyPack, Inc. (Torrent)

The FDA is also investigating other related blood pressure drugs, including
losartan (Cozaar) and olmesartan (Benicar). However, these drugs are
not yet included in the recall. The FDA has continued to update their website
as new information becomes available regarding the recall.

What should you do if your medication was part of the recall?

Contact your pharmacist or prescribing physician, if you have concerns
that your medication may have been part of the recall. We recommend asking whether
any of your medications prescribed since 2012 could have been part of the
recall, as it is possible that recall notices may be sent only regarding
current prescriptions. Do not stop taking recalled medication without
first contacting your prescribing physician. Valsartan alternatives exist.
Abruptly stopping valsartan without a replacement could cause serious
harm. Be sure to keep any prescription bottles and recall notices. Contact
your primary care physician for appropriate testing if you are concerned
that recalled valsartan may have affected your health.

Contact an attorney to learn about your rights. The aggressive trial lawyers
at Wagner Reese, LLP are hard at work investigating potential claims against
valsartan manufacturers. Call (888) 204-8440 for a free consultation.