Popular acid reflux and heartburn medication Zantac (ranitidine) may be contaminated with cancer-causing chemical NDMA. In 2018, multiple investigations showed the presence of NDMA (N-nitrosodimethylamine) in multiple formulations of Zantac and generic or store-brand ranitidine products, including those sold over-the-counter.
Drugstore chains and big-box stores began removing Zantac and ranitidine products from their shelves in 2019. Many Zantac and ranitidine medications were voluntarily recalled, and the U.S. Food and Drug Administration issued a warning to patients and health care practitioners.
The FDA did not advise patients to discontinue their medications, instead recommending that they talk to their healthcare providers for alternative treatments. All ranitidine, including name-brand Zantac, was officially recalled by the FDA in 2020.
People who took Zantac and were diagnosed with cancer may be eligible for compensation.
What Is NDMA?
European and U.S. health agencies including the U.S. Food and Drug Administration (FDA) have warned that popular heartburn drug Zantac, and other generic or store brand formulations of over-the-counter acid-reducers and prescription forms of Ranitidine, may contain a cancer-causing agent, N-nitrosodimethylamine (NDMA).
NDMA is a semi-volatile organic compound used as a stabilizer in gasoline, rocket fuel and other petroleum-based industrial products and is a byproduct of pesticide manufacturing and other industries. NDMA is a known human carcinogen according to the U.S. Environmental Protection Agency (EPA).
NDMA is known to be an environmental contaminant and is commonly found in:
- Dairy products
NDMA levels in Zantac and Ranitidine products, however, have been found to be 3,000 to 26,000 times higher than legally allowed levels which were set by the FDA. NDMA is one of the chemicals which led to the recall of blood pressure medications, valsartan and losartan, in 2018.
The presence of NDMA in Zantac and other drugs with ranitidine was discovered by private company Valisure. Valisure alerted the FDA of their findings and has identified information regarding the cancer risk of Zantac and other ranitidine-based drugs in medical studies published as early as the 1980s.
What Other Drugs Have NDMA?
Recently, other medications including the prescription high blood pressure medication, Diovan, or its generic, valsartan, have been under investigation for contamination with NDMA and similar agents. The FDA has required that a number of similar Angiotensin II Receptor Blockers (ARBs) be recalled for contamination with NDMA and similar chemicals. All ARB contamination appears to have originated at pharmaceutical ingredient manufacturing plants in China and India.
People who have been diagnosed or developed cancer after taking prescription Zantac, over-the-counter formulations, or other medications containing ranitidine may be eligible to seek compensation.
This type of contamination does not appear to be related to the NDMA that is present in Zantac and Ranitidine medications. Some evidence has shown that the NDMA which is appearing in Zantac may be caused by instability of the Ranitidine medication itself which may lead to the formation of the carcinogen under certain manufacturing or storage conditions. Experts have also postulated that the problem may not be new but may have been partially identified in the 1980s, becoming evident now with clearer and more accurate research methods.
What Cancers Does Zantac Cause?
Though health experts have stated that the short-term risk of NDMA-caused cancer from medication use may be low, longer-term exposure has not been fully evaluated. NDMA, however, has been shown to be a potent carcinogen in other industries.
Zantac and other ranitidine-based drugs have been linked to the following cancers:
What Are the Symptoms of Bladder Cancer?
Symptoms of bladder cancer may include:
- Back pain
- Having to urinate frequently
- Pain when urinating
- Pelvic pain
- Hematuria, or blood in the urine
The symptoms of bladder cancer frequently overlap with the symptoms of other conditions, so it’s important to look out for the more serious symptoms of bladder cancer, which involve pain. The most serious symptom is blood in the urine. If you experience this, contact a doctor immediately.
What Are the Symptoms of Kidney Cancer?
Symptoms of kidney cancer may include:
- Intermittent fever
- Persistent back or side pain
- Bloody urine (may appear pink, red, or cola-colored)
- Lack of appetite
- Unintentional weight loss
Kidney cancer often doesn’t have any symptoms in its early stages. Patients with kidney cancer can have it without knowing or experiencing any symptoms until the cancer has progressed to its later stages.
What Are the Symptoms of Breast Cancer?
Symptoms of breast cancer may include:
- A lump or thickening in the breast
- Changes in breast size, appearance, or shape
- Newly inverted nipples
- Changes, such as dimpling, redness, or pitting, to the skin on the breast
- Flaking, scaling, crusting, or peeling of the colored skin around the nipple
The greatest indicator of breast cancer is a lump or thickening in the breast. If you notice a lump, contact your doctor immediately.
What Are the Symptoms of Testicular Cancer?
Symptoms of testicular cancer may include:
- Back pain
- A lump in either one of the testicles
- An ache in the groin or the abdomen
- Discomfort or pain in the scrotum or testicles
- Breast enlargement or discomfort
- Fluid collection or swelling in the scrotum
- A heavy feeling in the scrotum
Typically, testicular cancer affects only one testicle rather than both. It’s important to contact your doctor immediately if you feel any lumps.
Can Testicular Cancer Affect Children?
Pregnancy can cause heartburn, which means that Zantac and other drugs with ranitidine may have been taken by pregnant women. Anything ingested by the mother, whether that’s food and drink or medication, can affect the fetus. Children are also sometimes prescribed Zantac syrup to treat acid reflux. However, children who take Zantac may have the same risk of cancer due to the NDMA found in ranitidine as adults who take a ranitidine-based drug.
What Are the Symptoms of Testicular Cancer in Children?
Testicular cancer can be different for children than for adults and teenagers. In infants and toddlers who are younger than the age of 2, any testicular tumors are fortunately more likely to be benign. However, these tumors would still require surgery in order to remove them. In older children, the chances increase of cancer being malignant.
Symptoms of testicular cancer in children may include:
- Abnormally-shaped testicles
- A hard mass or lump in a testicle
- Pain in a testicle
Some testicular tumors are painless, however, so it’s important to look for the other symptoms. The most important symptom to look for is a lump in the testicle, as that’s the primary sign of a tumor, whether it’s benign or cancerous.
What Are the Symptoms of Thyroid Cancer?
The thyroid gland is located behind the larynx or voice box. Cancer of the thyroid gland may cause metabolic changes which may increase or decrease weight, affect appetite, and result in other changes affecting multiple body systems.
Symptoms of thyroid cancer may include:
- Trouble swallowing
- Neck and throat pain
- Swollen lymph nodes in the neck
- A lump in the neck that can be felt through the skin
- Changes, especially hoarseness, in the voice
What Are the Symptoms of Prostate Cancer?
The prostate gland is only present in males and is located near the testicles. Prostate cancer mainly affects adult men, particularly older men. It is usually diagnosed through blood testing but tumors may be identified with a physical exam.
Symptoms of prostate cancer may include:
- Difficulty urinating
- Erectile dysfunction
- Bone pain
- Blood in the semen
- Pelvic discomfort
- Decreased urine stream force
When Did the FDA Warn of the Dangers of Zantac?
The FDA issued a statement in September of 2019 warning both patients and doctors of the potential risk of exposure to NDMA from taking Zantac or another ranitidine drug. The warning stated that work with partners in pharmaceutical and medical industry and with international regulators to determine the exact cause of the impurities was ongoing.
The FDA did not initially issue a recall for Zantac or ranitidine or advise patients to discontinue medications. The Agency recommended instead, that patients should discuss any concerns with a doctor
When Was Zantac Recalled?
Over concerns and publicity regarding NDMA, most Zantac and other drugs that contained ranitidine were voluntarily recalled in 2019. Pharmacy chains and big-box stores like CVS, Walmart, and Walgreens pulled both name-brand Zantac and store-brand drugs from their shelves. Manufacturers of Zantac and the other ranitidine-based drugs voluntarily recalled their own products shortly afterwards.
In 2020, the FDA concluded its investigations, finding an unacceptable amount of NDMA in ranitidine products and issued a nationwide recall of both name-brand Zantac and other ranitidine products
What Class Action Lawsuits Are there Against Sanofi?
In September 2019, a class-action lawsuit was filed against Sanofi, the manufacturer of Zantac. The plaintiffs accused the company of intentionally misleading patients about the safety of Zantac and concealing the risk of exposure to NDMA, which is a known carcinogen, or cancer-causing substance. The lawsuit alleges that Sanofi’s record sales of Zantac, which was the first drug to reach $1 billion in sales, were only possible because of this deception and that Sanofi valued profits over the lives and health of patients. These lawsuits were consolidated into multidistrict litigation (MDL 2924) in February 2020, in the Southern District Court of Florida.
In July 2021, Judge Robin L. Rosenberg dismissed cases against generic ranitidine product manufacturers because federal law prevented them from being sued. Later, in December 2022, Judge Rosenberg dismissed cases associated with the MDL due to a lack of decisive evidence linking Zantac to cancer development. This ruling requires plaintiffs to file their cases individually in federal court for their claims to be considered. Plaintiffs intend to appeal this decision to secure rightful compensation for cancer they developed after taking Zantac.
In addition to this MDL, separate Zantac lawsuits are actively being filed and heard in state courts across the U.S. The next Zantac lawsuit set to go to trial will be in California state court on November 13, 2023.
Should I Consider a Lawsuit?
People who have been diagnosed or developed cancer after taking prescription Zantac, or over-the-counter formulations, or other medications containing ranitidine may be eligible for compensation.
Eligibility for filing a Zantac lawsuit include those who used Ranitidine regularly for over 60 days and were diagnosed with:
- Bladder cancer
- Kidney cancer
- Breast cancer
- Testicular cancer
- Thyroid cancer
- Prostate cancer
People whose cancer diagnosis occurred more than 6 months after discontinuing ranitidine use, must have taken brand-name prescription or over-the-counter Zantac or certain store brands of ranitidine regularly for more than 1 year.
Zantac cancer lawsuits may provide compensation for damages including:
- Past and future medical costs
- Lost wages
- Pain and suffering
- Temporary or permanent disability
- Punitive damages
- Wrongful death
People or loved ones of those who may have developed cancer after using Zantac (ranitidine) may be eligible for compensation.
*Prior results do not guarantee or predict a similar outcome in any future matter.