The FDA first approved Zantac in 1983. Although it wasn’t exactly known how it worked, Zantac was approved for treating stomach ulcers and other conditions linked to too much stomach acid. Zantac is based on a substance called ranitidine. After the patent on Zantac expired in 1997, numerous competitors began to sell generic versions of Zantac, all based on ranitidine.
In 2018, ranitidine was found to be linked to the cancer-causing NDMA (N-nitrosodimethylamine). Investigations into ranitidine began, prompting drugstore chains to begin pulling ranitidine-based drugs, including Zantac, from their shelves in 2019. As a precaution, manufacturers of Zantac and other ranitidine-based drugs voluntarily recalled the drugs that same year.
At the same time, the FDA was investigating ranitidine and had announced a warning, although as of 2019 it hadn’t issued a recall or instructed patients to stop taking the drug, despite the recalls. Finally, in 2020, the FDA concluded its investigation and announced a recall of Zantac and other drugs based on ranitidine.
What Is NDMA?
European and U.S. health agencies including the U.S. Food and Drug Administration (FDA) are warning 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
However, it’s found in such low amounts in food and water that the FDA considers them safe for consumption. 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 what led to the recall of valsartan and losartan in 2018.
The presence of NDMA in Zantac and other drugs with ranitidine was discovered by a private company called Valisure. Valisure alerted the FDA and said that there had actually been clues pointing to the cancer risk of Zantac and other ranitidine-based drugs from medical studies published as early as the 1980s. However, Zantac and the other drugs were not recalled and there was no FDA warning until 2019.
What Other Drugs Have NDMA?
Recently, other medications including the prescription high blood pressure medication, Diovan, or 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.
This type of contamination does not appear to be related to the NDMA that is present in Zantac and Ranitidine medications. Some evidence is showing 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?
The symptoms of bladder cancer can 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?
The symptoms of kidney cancer can 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?
The symptoms of breast cancer can 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?
The symptoms of testicular cancer 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 collecting 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 the child ingests the Zantac, there is the same risk of cancer in children as a result of the NDMA found in ranitidine as there is for 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 the cancer being malignant.
The symptoms of testicular tumors in children can include:
- Abnormally-shaped testicles
- A hard mass or lump in the testicle
- Pain in the 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 symptoms of thyroid cancer can 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 symptoms of prostate cancer can 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. In the FDA’s announcement, the organization explained that it was working with partners in the industry and with international regulators in order to determine the exact cause of the impurities.
At the time, it did not issue a recall or advise patients to stop taking the drug. The FDA did advise, however, that patients should discuss any concerns with a doctor. Patients taking Zantac or another ranitidine-based drug were also advised to speak with their doctor before stopping taking their medication or changing medications.
When Was Zantac Recalled?
Because of the links between ranitidine and unacceptable levels of NDMA, Zantac and other drugs that contained ranitidine were voluntarily recalled in 2019. First pharmacies like CVS, Walmart, and Walgreens pulled the drugs from their shelves, including Zantac as well as their own versions of ranitidine drugs. Later that same year, the manufacturers of Zantac and the other ranitidine-based drugs voluntarily recalled their own products.
As of 2019, the FDA was investigating ranitidine, but had not yet issued any kind of recall or had even advised patients taking Zantac or another version of the drug to stop taking it, issuing only a warning in the meantime. It wasn’t until 2020 that the FDA concluded its investigations and found that there was an unacceptable amount of NDMA in ranitidine and issued its own recall.
What Class Action Lawsuits Are there Against Sanofi?
In September of 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.
What Zantac Lawsuit Settlements Are There?
The lawsuits against Sanofi are still ongoing. Therefore, no settlements have been determined yet. The settlement is the agreement that both parties come to as the resolution of the lawsuit. In successful cases, this typically involves money paid out for medical bills, pain and suffering, lost wages, etc. to the plaintiff or plaintiffs.
Should I Consider a Lawsuit?
People who have been diagnosed or developed cancer after taking Zantac prescription 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.
How Do I Find a Zantac Lawyer?
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.