Valsartan Cancer Side Effects
In July 2018, the FDA warned consumers throughout the United States that many versions of generic valsartan and valsartan HCTZ drugs distributed in recent years to treat high blood pressure and chronic heart failure may contain a cancer causing impurity known as N-nitrosodimethylamine (NDMA), which is a human carcinogen.
Side effects of NDMA in recalled valsartan pills may result in the development of:
- Bladder Cancer
- Colon Cancer
- Colorectal Cancer
- Esophageal Cancer
- Intestinal Cancer
- Leukemia
- Liver Cancer
- Lung Cancer
- Multiple Myeloma
- Non-Hodgkins Lymphoma
- Prostate Cancer
- Rectal Cancer
- Small Intestine Cancer
- Stomach or Gastric Cancer
The product liability lawyers at Saiontz & Kirk, P.A. are investigating potential valsartan cancer lawsuits for individuals and families nationwide who took NDMA contaminated valsartan drugs.
All valsartan class action lawsuits and personal injury cases are handled on a contingency fee basis, which means that there are no fees or expenses unless a settlement is obtained for an injury caused by recalled valsartan side effects.
See if you qualify for a Valsartan cancer lawsuit settlement by filling out the form below.
Did You or a Loved One Develop Cancer after using Recalled Valsartan?
Can Recalled Valsartan Cause Cancer?
Recalled Valsartan has been found to contain potentially dangerous levels of N-nitrosodimethylamine (NDMA), which is a chemical compound that has been classified as a possible human carcinogen by the World Health Organization, the U.S. Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC).
Since NDMA is a known contaminant, there are already set limits on how much NDMA is allowed in food. However officials have indicated that recalled valsartan drug contained NDMA levels that exceeded “safe” levels for an estimated four years.
Valsartan NDMA cancer risks were first raised on July 5, 2018, when the European Medicines Agency (EMA) announced that it was recalling several valsartan products after NDMA was detected in batches of the active ingredient supplied by Zhejiang Huahai Pharmaceuticals in China.
The FDA subsequently issued a valsartan recall on July 13, 2018, which has been expanded several times to include a number of different manufacturers and Valsartan drug products found to be contaminated with NDMA caused by bad manufacturing processes. The FDA has maintained a Valsartan recall timeline on its website titled FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan), which lists recalled Valsartan batches and provides recommendations to users.
According to the FDA, estimates suggest that individuals taking the highest dose of recalled valsartan containing NDMA between 2015 and late 2018 would have resulted in additional cases of cancer due to continuous exposure to the carcinogen. At high doses, NDMA in Valsartan can also be poisonous, leading to severe liver damage, bleeding and death.
Valsartan Cancer Risk Study: 2022
In a study published in the Journal of the American Heart Association in December 2022, researchers sought to assess the relationship between exposure to NDMA-contaminated valsartan and the occurrence of cancer, utilizing data from the Système National des Données de Santé, a comprehensive French national health database.
The study included consumers of valsartan between January 1, 2013, and December 31, 2017, aged between 40 and 80 years old, with no prior history of cancer. A total of 1.4 million subjects were included in the analysis, including 986,126 patients were exposed to NDMA-contaminated valsartan, while 670,388 were exposed to uncontaminated valsartan during the specified period.
According to the findings, individuals exposed to valsartan had an increased risk of cancer compared to those who were unexposed, finding;
- Any Malignancy: 55,690 cancer cases in Valsartan users versus 33,174 cases in those unexposed.
- Breast Cancer: 8,085 cases in Valsartan users versus 4,376 cases in those unexposed.
- Prostate Cancer: 10,358 cases in Valsartan users versus 6,734 cases in those unexposed.
- Colon Cancer: 4,866 cases in Valsartan users versus 2,815 cases in those unexposed.
- Rectal Cancer: 1,303 cases in Valsartan users versus 758 cases in those unexposed.
- Liver Cancer: 1,473 cases in Valsartan users versus 789 cases in those unexposed.
- Melanoma: 2,410 cases in Valsartan users versus 1,297 cases in those unexposed.
How Does Valsartan NDMA Contamination Cause Cancer?
Valsartan NDMA contamination poses a significant risk of cancer due to the compound’s carcinogenic properties. NDMA is a compound known to induce tumor formation in various organs like the gastrointestinal tract, liver, lungs, kidneys, and other areas of the body .
Exposure to NDMA from recalled Valsartan may lead to cancer through multiple mechanisms. Firstly, it can directly activate oncogenes like RAS, which regulate cell proliferation and are frequently implicated in cancer development. Additionally, NDMA undergoes metabolism in the body, generating methyldiazonium, a mutagenic metabolite capable of causing genetic mutations in cells. These mutations disrupt normal cellular processes, resulting in uncontrolled growth characteristic of cancer.
According to a Danish nationwide cohort study published in The BMJ in September 2018, researchers found that exposure to NDMA increased the risk of cancer by nine percent, with a notable elevated risk for colorectal and uterine cancer.
NDMA forms due to reactions by chemicals called alkylamines. While it was once used as an ingredient in rocket fuel, it is no longer intentionally manufactured. However, it may be created as a byproduct of some chemical manufacturing processes, which is what U.S. and European investigators say happened with recalled valsartan products.
Fortunately, NDMA does not persist long in the environment, breaking down quickly when exposed to sunlight and only lasting a few months in soil. However, it could persist for long periods of time in medication tablets, which are kept out of direct sunlight.
While early studies and testing suggest the risks of cancer is low, the investigation into the potential side effects of valsartan NDMA exposure is still ongoing and it appears likely that many individuals may have avoided a diagnosis if they had not been given contaminated pills.
What Cancers are Linked to Recalled Valsartan?
Individuals who took recalled valsartan may face an elevated risk of developing cancer. Recent studies have highlighted concerning trends showing an increased incidence of various types of cancer among individuals exposed to valsartan compared to those who are unexposed.
Bladder Cancer
Exposure to NDMA from recalled Valsartan can increase the risk of bladder cancer by damaging DNA within bladder cells and triggering uncontrolled cellular proliferation that can lead to the formation of a tumor.
Bladder cancer is often marked by symptoms like blood in the urine, frequent urination, and pain during urination. Survival rates vary depending on the stage at diagnosis, ranging from around 77% for localized bladder cancer to around 5% for metastatic bladder cancer.
Colon Cancer
Taking Valsartan contaminated with NDMA may cause colon cancer by causing DNA damage in the cells lining the colon and rectum, resulting in the growth of malignant masses.
Symptoms of colon cancer may include changes in bowel habits, blood in stool, abdominal discomfort, and unexplained weight loss. Survival rates for colon cancer range from about 90% for localized tumors to around 14% for distant metastases.
Intestinal Cancer
NDMA exposure from recalled Valsartan may cause intestinal cancer by causing DNA damage in the cells lining the intestines, culminating in the development of cancerous nodules.
Symptoms of intestinal cancer may include abdominal pain, changes in bowel habits, blood in stool, and unexplained weight loss. Survival rates for intestinal cancer vary depending on the specific type and stage of the cancer.
Leukemia
NDMA exposure from Valsartan may cause leukemia by interfering with the normal functioning of bone marrow cells, leading to the overproduction of abnormal white blood cells characteristic of leukemia.
Leukemia symptoms include fatigue, frequent infections, easy bruising or bleeding, weight loss, and swollen lymph nodes. Survival rates for leukemia vary widely depending on factors such as the type of leukemia and the patient’s age and overall health.
Liver Cancer
Individuals taking NDMA contaminated Valsartan products may be at an increased risk of liver cancer, due to NDMA’s ability to damage liver cells and interfere with their normal function, which can trigger the emergence of tumor formations.
Symptoms of liver cancer include abdominal pain, jaundice, unexplained weight loss, and swelling in the abdomen. Survival rates for liver cancer are generally poor, with a five-year survival rate of around 18%.
Lung Cancer
NDMA exposure from recalled Valsartan may cause lung cancer by damaging the cells lining the lungs, stimulating the growth of cancerous growths.
Lung cancer symptoms include coughing, chest pain, shortness of breath, and coughing up blood. Survival rates for lung cancer vary depending on the stage at diagnosis and other factors, with overall five-year survival rates ranging from about 10% to 20%.
Multiple Myeloma
The impact of NDMA on plasma cells can lead to the uncontrolled growth of cancerous cells, characterizing multiple myeloma with symptoms like bone pain and frequent infections.
Symptoms of multiple myeloma may include bone pain, weakness, frequent infections, and easy bruising. Survival rates for multiple myeloma have improved in recent years, with around 53% of patients surviving five years after diagnosis.
Esophageal Cancer
NDMA exposure from Valsartan may cause esophageal cancer by damaging the cells in the esophagus, leading to the development of cancerous tumors.
Esophageal cancer symptoms include difficulty swallowing, chest pain, weight loss, and persistent coughing. Survival rates for esophageal cancer are generally low, with around 19% of patients surviving five years after diagnosis.
Non-Hodgkin’s Lymphoma
NDMA exposure from contaminated Valsartan may cause non-Hodgkin’s lymphoma by damaging the cells of the lymphatic system, leading to the development of cancerous lymphocytes.
Symptoms of non-Hodgkin’s lymphoma include swollen lymph nodes, fever, night sweats, fatigue, and unexplained weight loss. Survival rates for non-Hodgkin’s lymphoma vary depending on the specific type and stage of the cancer.
Prostate Cancer
NDMA exposure from Valsartan may cause prostate cancer by causing DNA damage in the cells of the prostate gland, provoking the growth of cancerous tumors.
Prostate cancer symptoms may include difficulty urinating, blood in semen, erectile dysfunction, and bone pain. Survival rates for prostate cancer are generally high, with around 98% of patients surviving five years after diagnosis.
Rectal Cancer
NDMA exposure from Valsartan may cause rectal cancer by causing DNA damage in the cells lining the rectum, culminating in the development of tumor formations.
Symptoms of rectal cancer may include changes in bowel habits, rectal bleeding, abdominal pain, and weakness. Survival rates for rectal cancer depend on various factors, with five-year survival rates ranging from around 74% to 92%.
Small Intestine Cancer
NDMA exposure from Valsartan may cause small intestine cancer by causing DNA damage in the cells lining the small intestine, leading to the formation of cancerous lesions.
Symptoms of small intestine cancer may include abdominal pain, unexplained weight loss, fatigue, and changes in bowel habits. Survival rates for small intestine cancer vary depending on the stage at diagnosis and other factors.
Stomach or Gastric Cancer
NDMA exposure from recalled Valsartan may cause stomach or gastric cancer by damaging the cells lining the stomach, initiating the formation of cancerous masses.
Stomach cancer symptoms include abdominal pain, indigestion, nausea, vomiting, and unexplained weight loss. Survival rates for stomach cancer vary depending on the stage at diagnosis, with overall five-year survival rates ranging from about 32% to 69%.
Individuals who have taken recalled Valsartan drugs that have experienced any of the cancer symptoms above are being encouraged by the FDA to contact their doctor immediately.
Valsartan Cancer Lawyers
The lawyers at Saiontz & Kirk, P.A. are reviewing potential valsartan class action lawsuits, as well as individual cancer claims for individuals diagnosed following use of the recalled hypertension drugs.
As a result of the failure to follow proper manufacturing practices, individuals were exposed to a risk of cancer that would not have otherwise been associated with side effects of valsartan.
If you or a loved one has been diagnosed with cancer after taking recalled valsartan products, request a free consultation and claim evaluation. All claims are handled on a contingency fee basis, meaning there are never any out-of-pocket expenses and no fees unless a recovery is obtained.