Blood Pressure Medication Recall: the Dangers

NDEA (Nitrosodiethylamine) as a Human Carcinogen - NDEA and NMDA are carcinogens which have recently been found in a number of high blood pressure medications, most of which have since been recalled. The flagged and recalled medications include amlodipine, valsartan, losartan, irbesartan and hydrochlorothiazide. Many of these tainted blood pressure drugs have been found to contain N-nitroso-diethylamine, or NDEA. NDEA is an organic chemical which is known as an animal carcinogen and is a suspected human carcinogen as well, according to the FDA. NDEA can be toxic to the liver and other organs. Researchers from Aligarh Muslim University found in 2015 that high doses of NDEA caused severe injury to the liver and red blood cells in rats, leading to liver cancer and liver damage.

This particular study was published in the Interdisciplinary Toxicology Journal which clearly suggested the damage done by NDEA and other nitrosamines such as NDMA, can interfere with the proper functioning of the liver. NDEA is used to make liquid rocket fuel, water softeners and lubricant. NDEA is a yellowish, oily liquid with little odor or taste, and is a byproduct of industrial processes like rubber tire manufacturing. The long-term risks of the chemical found in the recalled hypertension drugs are unknown currently, however, the FDA is examining the levels of NDEA found in the medications and assessing the effects on patients.

The U.S. Environmental Protection Agency has classified NDMA as a “probable human carcinogen,” meaning that it probably causes cancer in human beings. It has also been classified as a “confirmed animal carcinogen,” meaning it does cause cancer in animals. The EPA also reports that NDMA exposure can cause liver damage. The World Health Organization lists NDMA as “probably carcinogenic to humans,” stating it is released as a byproduct from municipal wastewater treatment plants and some other industrial manufacturing facilities. The federal government lists NDMA as a “priority toxic pollutant.”

The FDA states that NDMA can reasonably be anticipated to cause cancer in humans, with short-term exposure to NDMA causing liver damage and long-term exposure increasing the risk of lung, kidney and liver tumors. Scientists have used NDMA in the past to cause cancer in rats used for research—colorectal cancer, liver cancer, gastric cancer and kidney cancer. There are symptoms of too much exposure to NDMA, such as chronic headaches, nausea, fever, vomiting, jaundice, enlarged liver, reduced liver, kidney and lung functions, dizziness and abdominal cramps. A 2018 study done in Denmark showed that NDMA and NDEA exposure can potentially cause pancreatic, rectal, colon, stomach and liver cancer.

High doses of NDMA (much higher than those found in the recalled blood pressure medications), have even been used as a poison in murders. Although the levels used to commit a crime were extremely high, and the amount found in the recalled blood pressure medications is relatively low, these substances have nonetheless been linked to cancer and liver damage.   

Valsartan Side Effects and Dangers - Valsartan is the generic form of Diovan and is used to control hypertension, as well as for heart failure and post-heart attack. The common valsartan side effects include:

  • Chronic headaches;
  • Diarrhea;
  • Upper respiratory infections;
  • Fatigue;
  • Flu-like symptoms;
  • Dizziness;
  • Nausea;
  • Stomach pain;
  • Joint pain;
  • Back pain;
  • Skin rashes and itching;
  • Blurry vision, and
  • Inflammation.

More serious side effects of valsartan include chest pain, swelling of the lips and eyes, weight loss, palpitations and shortness of breath. Valsartan can interact with cyclosporine, diuretics, and NSAIDS. The recalled valsartan cancer drug, which have been found to have NDEA and NDMA in them, have the potential to cause cancer and liver damage.

Losartan Side Effects and Dangers - Losartan, like valsartan, belongs to a group of drugs known as angiotensin II receptor antagonists which keep blood vessels from narrowing, thus lowering blood pressure. Losartan has been used to slow long-term kidney damage in those with type 2 diabetes, who also have high blood pressure. In rare cases, losartan can cause a condition resulting in the breakdown of skeletal muscle tissue, potentially leading to kidney failure. Some common losartan side effects include:

  • Muscle cramps;
  • Cold or flu symptoms, including a dry cough;
  • Pain in the back or legs;
  • Stomach pain or diarrhea;
  • Chronic headache or dizziness;
  • Feeling tired, and
  • Sleep issues.

Losartan cancer has been alleged in the losartan drugs which have been tainted by NDEA and NDMA.

Irbesartan Side Effects and Dangers - Like losartan and valsartan, irbesartan is an angiotensin II receptor antagonist. Irbesartan keeps the blood vessels from narrowing, thus lowering blood pressure and improving blood flow. Irbesartan is sometimes used to treat kidney problems caused by type 2 diabetes. Typical irbesartan side effects include a light-headed feeling, little or no urination, rapid weight gain, swelling, confusion, loss of appetite, vomiting and pain in the side or lower back. Irbesartan cancer can result from irbesartan blood pressure drugs containing NDEA and NDMA.

Amlodipine Side Effects and Dangers - Amlodipine side effects can include the following:

·                     Swelling in the legs or ankles;

·                     Extreme sleepiness;

·                     Tiredness;

·                     Stomach pain;

·                     Nausea;

·                     Dizziness;

·                     Flushing in the face;

·                     Irregular heart rate, and

·                     Heart palpitations.

Like losartan, valsartan, and irbesartan, some amlodipine drugs have been found to contain NDMA and NDEA. NDMA and NDEA have been found to cause cancer in laboratory animals and have been deemed potential and probable carcinogens.

Hydrochlorothiazide Side Effects and Dangers - The drug hydrochlorothiazide (HCTZ) is a thiazide diuretic which helps prevent the body from absorbing too much salt, which can cause fluid retention. Hydrochlorothiazide treats fluid retention in those with congestive heart failure, kidney disorders or cirrhosis of the liver. Hydrochlorothiazide side effects include:

·                     Eye pain and vision problems;

·                     A red, blistering, peeling skin rash;

·                     Numbness or tingling;

·                     Dry mouth;

·                     Thirst;

·                     Nausea and vomiting;

·                     Drowsiness;

·                     Weakness;

·                     Fast or uneven heartbeat, or

·                     Muscle pain and muscle weakness.

Like losartan, valsartan, irbesartan, amlodipine, hydrochlorothiazide medications have been found to have NDMA and NDEA in certain lots, and NDMA and NDEA have been shown to cause cancer in laboratory animals.

Getting the Help You Need After Taking one of the Recalled High Blood Pressure Medications - If you have taken any of the recalled high blood pressure drugs, you could potentially have a claim against the manufacturer. It could be extremely beneficial to your future to speak to a Sullo & Sullo personal injury attorney regarding a valsartan cancer lawsuit, a losartan cancer lawsuit, an irbesartan cancer lawsuit, an amlodipine cancer lawsuit or a hydrochlorothiazide cancer lawsuit. Your Sullo & Sullo personal injury attorneys can ensure your rights and your future are properly protected.
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