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 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.