Why NDEA, NDMA Causes Cancer
You may have heard of defective heartburn drugs recalled by the U.S. Food and Drug Administration due to cancer-causing impurities known as NDEA and NDMA. But what are these elements, and why do NDEA and NDMA cause cancer?
What is NDMA?
First, we’ll explore what is NDMA. It’s an organic compound which can be carcinogenic, meaning it can cause cancer in humans -- even at extremely low levels. The technical name for NDMA is N-nitrosodimethylamine. It is sometimes mistakenly referred to as NMDA. The International Agency for Research on Cancer, or IARC, and the World Health Organization, or WHO, both report that NDMA is a possible carcinogen in humans and definitely can cause cancer in animals.
Unfortunately, since NDMA is found in some batches of hypertension medication valsartan, users may have consumed large levels of NDMA over a period of time, since they may have taken valsartan up to two times daily over the course of several years. But even a single high dose of NDMA can result in internal bleeding, severe liver damage and death. High to moderate amounts of NDMA consumed by animals can lead to liver damage in just a few days and can result in cancer after just a few weeks.
Generic valsartan has been sold for four years, but NDMA was only recently discovered to be present in some generic valsartan products. These are oral tablets prescribed to treat hypertension, or high blood pressure. The impurity is believed to have been an inadvertent byproduct in overseas manufacturing processes for valsartan, which then led to defective and harmful BP meds being sold in the United States. Recently in September 2019, the FDA announced that the popular GERD and heartburn medicine called Zantac also contains NDMA and has issued a news release (See: Zantac Cancer News)
NDMA Side Effects
Harmful side effects of NDMA include:
- Kidney cancer
- Colon cancer
- Liver cancer
- Intestinal cancer
- Bowel cancer
- Bladder cancer
- Colorectal cancer
- Gastric or stomach cancer
- Pancreatic cancer
Overexposure to NDMA in valsartan BP meds can include these symptoms:
- Enlarged liver
- Impaired lungs
- Impaired liver
- Cramping of the abdomen
- Swelling of the feet, hands or ankles
Valsartan NDMA Recalls
Discovery of cancer-causing NDMA in generic valsartan products has led to NDMA recalls advised by the U.S. Food and Drug Administration. The FDA continues to investigate other blood pressure drugs for harmful elements, and already it also has found them in generic losartan and generic irbesartan, which both feature the related carcinogen called NDEA. Though only a small percentage of generic valsartan products may harbor cancer-causing NDMA, it is vital to protect those who have been exposed -- or may be exposed -- to the impurity.
That’s why valsartan recalls already have been made by Torrent Pharmaceuticals Ltd., Teva Pharmaceuticals, Solco Healthcare, Mylan Pharmaceuticals and Major Pharmaceuticals, with still more valsartan recalls likely to follow. If you take generic valsartan, contact your pharmacist or prescribing physician to learn if your BP med is on the valsartan recall list. But do not stop taking your blood pressure medication before consulting your physician, who can prescribe an alternative to begin taking immediately upon stopping use of valsartan. See > Updated FDA Valsartan Recall list
What is NDEA?
Now, let’s learn what is NDEA. It is a similar organic compound to NDMA, and it also can cause cancer in humans. The technical name for NDEA is N-nitrosodiethylamine. NDEA is not found in generic valsartan but rather in generic irbesartan and generic losartan. All such products are in a family of drugs called ARB, which stands for angiotensin II receptor blockers. Such drugs treat high blood pressure by loosening restricted blood vessels in order to prevent heart attacks or strokes. As with NDMA in generic valsartan, NDEA in generic irbesartan and generic losartan is an accidental byproduct of the manufacturing process to produce the BP meds.
Sometimes NDEA is meant to be present in a product -- but never in prescription drugs. Rather, NDEA is deliberately used in industrial materials and in gasoline as a stabilizer. Some manufacturers also use NDEA in the production of liquid rocket fuel. Imagine having such an element in your body. The impurity of NDEA found in generic losartan was believed to have been produced by Lek Pharmaceuticals of Ljubljana, Slovenia. Generic irbesartan impurities stemmed from production by India’s Aurobindo Pharma Limited.
NDEA Side Effects, NDEA Symptoms
Side effects and symptoms of NDEA are basically the same as for NDMA, as listed above. Users of defective generic losartan and generic irbesartan should be alert to these side effects and symptoms and should alert their physician immediately if they believe they are suffering from them after taking the drugs.
NDEA, NDMA Cancer Lawsuits
Victims of defective generic versions of BP meds valsartan, losartan and irbesartan can claim payments for their injury losses by engaging an experienced defective drug lawyer with our law firm and then seeking NDEA or NDMA cancer lawsuits. Such injury lawsuits can claim payments for various losses suffered by victims due to the defective drug, including lost salary or wages owing to the injury, medical costs, hospital expenses and pain and suffering.
Contact our law firm today to receive a free and no-obligation legal review of your case. If NDEA or NDMA have caused cancer in you or a loved one after taking BP meds irbesartan, losartan or valsartan, you have a legal right to seek financial compensation for your injury losses. You will pay nothing until or unless your case prevails in court or via an out-of-court settlement, and then only a portion of the settlement you win, and nothing from your own pocket. Contact us today to explore your prospects for a successful lawsuit over cancer-causing NDEA and NDMA in your blood pressure medication.