What Are Zantac’s Links to Cancer?
Popular heartburn drug Zantac and other generic formulations containing ranitidine may contain a carcinogenic compound that has been detected in other contaminated medications. Zantac’s manufacturer Sanofi-Aventis has announced that it has undertaken a voluntary recall of the medication over cancer concerns. Other formulations of ranitidine including store brand products such as Rite Aid or CVS Acid Reducer, Walgreens’ Wal-Zan, other brands of Acid Controller, Acid Reducer, or Heartburn relief products and generic products containing ranitidine have also been permanently removed from shelves of retailers.
In September of 2019, the U.S. Food and Drug Administration (FDA), along with European and other health authorities warned that heartburn and reflux medications containing ranitidine, including popular brand-name drug Zantac, may contain a carcinogen known as NDMA.
In April of 2020, the FDA, which had previously only issued warnings about the cancer risks of Zantac and other ranitidine-based drugs, issued a recall of the drug. The FDA has now warned anyone taking the drug to stop taking the medication and it’s also no longer available for sale.
What is Ranitidine?
Ranitidine is the generic name of a class of H2-blocker medications. Ranitidine-based drugs are most commonly prescribed for stomach and intestinal ulcers, heartburn, GERD, Zollinger-Ellison Syndrome, among other conditions. It was prescribed for any condition in which the stomach produced too much acid or stomach acid was able to back up into the esophagus.
What Are the Brand Names of Ranitidine?
Although ranitidine is the generic name, many people would know it better under one of the brand names it was sold under. These brands include:
- Zantac 75
- Zantac 150
- Zantac Maximum Strength
- Wal-Zan 150
- Wal-Zan 75
- Acid Reducer (ranitidine)
- Acid Control (ranitidine)
- Heartburn Relief (ranitidine)
Who Makes Zantac?
Zantac, including Zantac 75, Zantac 150, and Zantac Maximum Strength, is manufactured by a company called Sanofi. Other companies that have produced similar ranitidine-based products include Walmart, CVS, and Rite Aid, which have their own brand. All of these companies have now voluntarily recalled their ranitidine products.
How Does an H2-Blocker Work?
H2-blockers, or histamine h2-receptor antagonists, reduce the amount of acid that is produced in the stomach. They work by blocking the histamine h2 receptors in the stomach’s parietal cells from producing stomach acid, which is a mixture of hydrochloric acid, potassium chloride, and sodium chloride.
While ranitidine is an h2 blocker, it’s not the only generic type of h2-blocker available. Other h2-blockers include:
- Pepcid Oral
- Pepcid AC
- Nizatidine Capsules
- Axid Capsules
- Axid AR
- Nizatidine Capsules
- Tagamet HB
What Conditions Does Zantac Treat?
Zantac and other ranitidine-based drugs are typically prescribed to treat conditions in which there is either too much stomach acid or stomach acid backs up into the esophagus. These conditions include:
- Zollinger-Ellison Syndrome
What is Heartburn?
Heartburn, which is a symptom of acid reflux, is a burning pain felt in the chest, right behind the breastbone. The sensation is typically worse when bending over or lying down, in the evening, or after eating.
What Causes Heartburn?
Heartburn occurs when stomach acid backs up into the esophagus. There’s a band of muscle, called the esophageal sphincter, at the bottom of the esophagus where it meets the stomach. When a person swallows, this band loosens in order to allow the food and drink to travel down the esophagus and into the stomach. Normally, the band then tightens again afterward to ensure that food and acid don’t travel back up the esophagus.
Acid reflux and heartburn occur when the esophageal sphincter loosens when it shouldn’t. Acid from the stomach can then flow up into the esophagus. The stomach’s lining protects the stomach from the acid, but the esophagus doesn’t have the same protection. Stomach acid, which isn’t even noticed when it’s on the stomach, causes the burning sensation of heartburn and can eventually irritate the esophagus.
Being pregnant or overweight can increase the risk of getting heartburn. In addition, there are certain foods that can trigger heartburn. These foods include:
- Carbonated beverages
- Fried foods
- Fatty foods
- Tomato-based products
- Spicy food
- Large meals
What Are the Symptoms of Heartburn?
The most common symptoms of heartburn are:
- Burning pain in the chest
- Acidic or bitter taste in the mouth
- Pain worsening:
- In the evening
- After eating
- When lying down
- When bending over
If heartburn only occurs occasionally, then it can be treated at home with either over-the-counter medication or lifestyle changes, such as avoiding foods that cause heartburn. However, there are some symptoms that indicate you should see a doctor:
- Trouble swallowing
- Difficulty eating
- Poor appetite
- Weight loss
- Heartburn more than two times a week
- Heartburn symptoms continue after over-the-counter medication
If heartburn occurs very frequently and is interfering with day-to-day life, it’s typically considered to be GERD.
What is GERD?
GERD is an acronym for gastrointestinal esophageal reflux disease. It occurs when acid reflux, or the flowing of stomach acid from the stomach up into the esophagus, happens frequently. The esophagus can get irritated by this acidic backwash. Although many people experience heartburn periodically, GERD is diagnosed when the heartburn or acid reflux is frequent enough to interfere with daily life.
What Causes GERD?
When the esophageal sphincter frequently is too loose and allows acid to back up from the stomach into the esophagus, GERD can occur. The constant presence of stomach acid in the esophagus can irritate the esophageal lining and result in inflammation.
What Are the Symptoms of GERD?
The most common symptoms of GERD include:
- Frequent heartburn
- Chest pain
- Trouble swallowing
- The feeling of a lump in the throat
- Regurgitation or sour liquid or food
- Chronic cough
- Disrupted sleep
Anyone experiencing chest pain should seek medical attention, especially if it is accompanied by pain in the arm or jaw and shortness of breath. These are symptoms of a heart attack.
What Are Risk Factors of GERD?
Although heartburn can happen to anyone, there are some factors that can increase the risk of it becoming GERD. These risk factors include:
- Scleroderma or other connective tissue disorders
- Delayed stomach emptying
- Hiatal hernia, or a bulging at the top of the stomach that goes up into the diaphragm
The following factors can make the acid reflux worse:
- Eating large meals
- Eating late at night
- Eating certain foods frequently
- Drinking coffee or other caffeinated beverages
- Taking aspirin or other similar medications
What Complications Can Occur from GERD?
The constant presence of stomach acid in the esophagus can have negative long-term effects. These complications include:
- Esophageal stricture
- This is the narrowing of the esophagus due to scar tissue that forms within the esophagus from the acid eating away at the lining of the esophagus.
- Esophageal ulcers
- The stomach acid can eat away at the esophagus, causing an open sore or ulcer to form. The ulcer can bleed, which can cause difficulty swallowing and pain.
- Barrett’s esophagus
- The stomach acid that gets into the esophagus can cause changes to occur in the tissue lining. These changes increase the risk of esophageal cancer.
What is Zollinger-Ellison Syndrome?
Zollinger-Ellison syndrome is a rare condition. In people with Zollinger-Ellison syndrome, tumors, called gastrinomas, form in the pancreas or in the duodenum, or upper intestine. These tumors secrete a chemical called gastrin which causes the stomach to produce extra stomach acid. That additional stomach acid in turn causes peptic ulcers, diarrhea, and other symptoms. While the disease can occur at any time, most people who develop the syndrome find its onset to be between the ages of 20 and 50.
What Causes Zollinger-Ellison Syndrome?
The cause of Zollinger-Ellison syndrome is currently unknown. However, some people develop the syndrome as a result of another condition called MEN 1. MEN 1, or multiple endocrine neoplasia, is a condition that causes tumors to form in the parathyroid glands and sometimes the pituitary glands. About 25% of people with Zollinger-Ellison syndrome get tumors because of MEN 1.
Anyone who has a relative with Zollinger-Ellison syndrome is more at risk to develop the syndrome themselves.
What Are the Symptoms of Zollinger-Ellison Syndrome?
The symptoms of Zollinger-Ellison syndrome include:
- Acid reflux
- Digestive tract bleeding
- Abdominal pain
- Decreased appetite
- Weight loss
- Discomfort such as gnawing, burning, or aching in the upper abdomen
It’s important to see a doctor if you’ve been experiencing diarrhea, vomiting, and nausea in conjunction with a persistent discomfort in the upper abdomen, which can take the form of gnawing, burning, or aching.
What Are Ulcers?
An ulcer is an open sore that develops inside the body. When they develop inside the stomach or upper intestine, they are called peptic ulcers. A peptic ulcer that forms inside the stomach is called a gastric ulcer while a peptic ulcer that forms inside the upper intestine is called a duodenal ulcer.
What Causes Stomach Ulcers?
Peptic ulcers occur when the acid in the stomach eats away at the actual surface of the stomach. This can also occur in the small intestine. The acid wearing away at the surface of the organ can cause an open sore to form, which is the ulcer. Normally, the protective layer of mucus in the stomach protects the organ itself from the acid inside, but there are some conditions that can either increase the amount of stomach acid or decrease the amount of mucus that can protect the organ from the acid.
These conditions include:
- pylori – This bacteria can get into the stomach’s protective lining, usually from close contact with a person that has it or through contaminated food or drink. Often this bacteria won’t cause any problems, but it can inflame the inner layer of the stomach, resulting in an ulcer.
- Pain relievers – Certain pain relievers, including aspirin, can irritate the stomach’s lining and cause inflammation, leading to ulcers. These medications include:
- Ibuprofen (Motrin IB, Advil)
- Neopren sodium (Anaprox, Aleve)
- Other medicines taken with NSAIDs:
- SSRIs (selective serotonin reuptake inhibitors)
- Low-dose aspirin
- Risedronate (Actonel)
- Alendronate (Fosamax)
What Are the Symptoms of Ulcers?
The most common symptom of a peptic ulcer is a pain in the stomach. However, there are additional symptoms that are indicative of the presence of an ulcer. These most commonly include:
- A feeling of being full
- Intolerance for fatty food
- Burning pain in the stomach
The stomach pain is caused by stomach acid on the open sore and is made worse by having an empty stomach. It’s possible to ease the pain by eating foods that can buffer against the stomach acid or by taking medication to reduce the amount of stomach acid produced.
Stomach ulcers can all have less frequent but more serious symptoms, including:
- Vomiting blood
- Black, tarry, or bloody stools
- Feeling faint
- Difficulty breathing
- Changes in appetite
- Weight loss that can’t be explained
If you’re experiencing any of the severe symptoms of a stomach ulcer, you should see a doctor.
What Are Risk Factors of Ulcers?
There are some factors that can increase the risk of developing ulcers. These risk factors include:
- Spicy food
These risk factors cannot cause ulcers by themselves. However, they can make existing ulcers worse and also make them more difficult and take longer to heal.
What Complications Can Occur from Ulcers?
Complications can occur from ulcers typically only if they’re left untreated. These complications can include:
- Obstruction – this is the blockage of the digestive tract by the ulcer, preventing food from traveling through.
- Internal bleeding
How Can Ulcers Be Prevented?
While ulcers may not be completely preventable, there are some steps that you can take to reduce your risk of getting them. These steps include:
- Don’t smoke
- Avoid alcohol
- Take care with spicy food
- Reduce stress
- Take precautions against infections (from H.pylori)
- Be careful when taking pain relievers
What Are the Side-Effects of Taking Zantac?
The side-effects of taking Zantac or another ranitidine-based drug include:
- Stomach discomfort
- Stomach pain
There are some more serious side-effects as well, including:
- Liver inflammation
- Stomach pain
- Dark urine
- Yellowing skin or eyes
- Blurred vision
- Shortness of breath
- Abnormal heart rate
Anyone experiencing any of these symptoms should contact their doctor immediately.
What is NDMA?
NDMA is known chemically as N-nitrosodimethylamine. NDMA is a semi-volatile compound used in or a byproduct of industrial applications such as petroleum and pesticide manufacturing.
It is used as a stabilizer in gasoline and other fuels along with other products such as industrial lubricants but is considered an environmental contaminant that is sometimes found in water and foods. NDMA is a known carcinogen and strictly regulated by the U.S. Environmental Protection Agency (EPA).
The FDA has warned that Zantac and generic products containing heartburn medication, ranitidine, may contain NDMA at levels that are 3,000 to 26,000 higher than legally allowed.
While short-term exposure to NDMA may carry a low risk of cancer development, experts have stated that longer-term risk of exposure in medication is not known. NDMA however has been shown to be carcinogenic in industrial settings.
The FDA and manufacturers have acknowledged that the active ingredient in Zantac, ranitidine, may be contaminated with NDMA. NMDA has also been found as a contaminant in other medications including the blood pressure medication, valsartan. In addition to recalls issued by Sanofi, other generic manufacturers and store brands have also been pulled from shelves and are no longer being sold at retail outlets such as Walgreens, CVS-Target, and Walmart.
Experts warn that though there are a number of alternative medications to ranitidine, people should consult their health care practitioner before suddenly discontinuing the medication.
What Other Drugs Have NDMA?
During 2018 and 2019, a number of medications containing the Angiotensin II Receptor Blocker (ARB) medication, Diovan, or generic formulations of valsartan, were recalled for contamination with NDMA and similar chemicals. All of the contaminated lots of medication thus far appear to have been made with valsartan active pharmaceutical ingredient (API) that was manufactured at chemical plants in India or China.
Though the valsartan contamination events continue to expand, and more valsartan medications require recall, this type of contamination does not appear to be related to the cause of problems with Zantac and ranitidine-containing products. Experts now believe that ranitidine, the active ingredient in Zantac and store brands or generics, may be unstable and under certain conditions, causing the formation of NDMA as something like a chemical byproduct. There is some evidence that concern about similar issues may have been raised as early as the mid-1980s.
What Cancers Can Zantac Cause?
Zantac and other ranitidine-based drugs have been linked to the following cancers:
- Breast cancer
- Testicular cancer
- Prostate cancer
- Stomach cancer
- Bladder cancer
- Kidney cancer
- Colon cancer
- Pancreatic cancer
- Other types of cancer
Some of these people or their loved ones may be considering filing Zantac (ranitidine) cancer lawsuits.
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
It’s important to see a doctor if you feel any kind of lump or thicker area in the breast tissue that doesn’t feel like the surrounding areas. Even if you’ve recently been to the doctor and all tests were returned normal, contact your doctor immediately.
What Are the Symptoms of Testicular Cancer?
The symptoms and signs 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
Testicular cancer typically only affects one testicle. Contact your doctor if you feel any lumps, especially if they persist for a few weeks.
What Are the Symptoms of Prostate Cancer?
Prostate cancer in its earlier stages typically doesn’t have any symptoms. However, later-stage prostate cancer can have symptoms such as:
- Difficulty urinating
- Erectile dysfunction
- Bone pain
- Blood in the semen
- Pelvic discomfort
- Decreased urine stream force
What Are the Symptoms of Stomach Cancer?
The signs of stomach cancer are also generally the same as those of gastroesophageal junction cancer. These symptoms include:
- A bloated feeling after eating
- A full feeling after eating only small amounts of food
- Frequent or persistent heartburn
- Persistent nausea that can’t be explained
- Weight loss that isn’t intentional
- Severe, constant indigestion
- Stomach pain
What Are the Symptoms of Bladder Cancer?
Some of the signs of bladder cancer are also symptoms of other conditions:
- Back pain
- Having to urinate frequently
It’s therefore essential to look out for the more serious symptoms of bladder cancer:
- Pain when urinating
- Pelvic pain
- Hematuria, or blood in the urine
Hematuria is the most serious symptom. If you notice blood in your urine, contact a doctor immediately.
What Are the Symptoms of Kidney Cancer?
Symptoms during the early stages of kidney cancer are rare. Kidney cancer typically only displays symptoms during its later stages. These later-stage symptoms may include:
- Intermittent fever
- Persistent back or side pain
- Bloody urine (may appear pink, red, or cola-colored)
- Lack of appetite
- Unintentional weight loss
What Are the Symptoms of Colon Cancer?
Most people with colon cancer don’t experience any symptoms early on. In later stages, the following symptoms can begin to develop:
- Bowel habit changes:
- Stool consistency
- Rectal bleeding (bloody stools)
- Inexplicable weight loss
- Abdominal discomfort:
- A feeling like the bowel isn’t completely empty
Colon cancer symptoms, when they do eventually appear, vary in severity depending on the person and how large the cancer growth is.
What Are the Symptoms of Pancreatic Cancer?
The symptoms of pancreatic cancer often don’t appear until the disease is in its later stages. These signs can include:
- Dark urine color
- Light stool color
- Abdominal pain that radiates around to the back
- Unintentional weight loss
- Loss of appetite
- Jaundice (the yellowing of skin and eyes)
- Blood clots
- Itchy skin
- Diabetes (either a new diagnosis or an old diagnosis that has become difficult to control)
In 2019, the FDA issued a warning about the presence of NDMA in Zantac and other drugs that are based on ranitidine. At the time, the FDA did not order a recall of any ranitidine-based drug at that time. The FDA said that although it had found the low levels of NDMA in ranitidine, there was not enough to be a cause for concern and that the amount in the drug was barely more than what would be found occurring in food. The FDA was still investigating nonetheless and requested that anyone who experienced an adverse reaction to a ranitidine-based drug contact the FDA’s MedWatch program to report it.
As of September 2019, the FDA was not recalling the drug or recommending that people stop taking it. The FDA did advise at that time that anyone with concerns or who did wish to switch medications should talk to their doctor about their options. The FDA advised that if a patient was prescribed a ranitidine-based medication, the doctor who had prescribed it had considered the benefits to outweigh any potential risks.
Zantac and Ranitidine Voluntary Recalls
Brand-name Zantac is manufactured by Sanofi-Aventis, who has issued a voluntary recall of its products. Generic manufacturers of prescription medications containing ranitidine include Novartis-AG’s Sandoz, Apotex, GlaxoSmithKline and others have also recalled their products, along with retailers whose store brands include CVS and Rite Aid Acid Reducer, Walgreens’ Wal-Zan, other store brand labels including Acid Control, Acid Reducer, Heartburn Relief and generic formulations of Ranitidine have also recalled their medications and removed them from store shelves.
Countries affected by Zantac and generic ranitidine recalls now include the U.S., Hong Kong, India, Pakistan, Taiwan, Canada, and countries of the European Union. The FDA has also requested that manufacturers act quickly to voluntarily remove any additional medications that may show the same degradation problems such as Axid or products containing a similar antacid, nizatidine.
In addition to manufacturer recalls, a number of large retailers including drugstore chains CVS and Walgreens and big-box store Walmart, have pulled Zantac and store-brand or generic ranitidine products off of store shelves. Similar actions have been taken at other stores around the U.S. and the FDA has stated that ranitidine has been permanently discontinued from the U.S. market.
Health experts have noted that there are a number of alternative medications available to treat heartburn in both prescription and over-the-counter formulations. The FDA has advised that patients should consult with their health care provider before making any changes to their regimen.
FDA Ordered Recall
On April 1, 2020, the FDA issued a recall of Zantac and all ranitidine-based medications. The FDA’s investigation into the presence of NDMA, a known carcinogen, in ranitidine had been ongoing even after issuing only a warning the previous year. The FDA concluded that the amount of NDMA in the drug could increase over time and over long-term usage expose patients to an unacceptable level of NDMA. Most ranitidine drug manufacturers had actually already voluntarily recalled their products in 2019. However, no new or existing prescriptions for Zantac or any other drug based on ranitidine will be able to be filled within the U.S.
At the time of its warning in 2019, the FDA didn’t have enough scientific evidence that the NDMA in ranitidine was a risk to issue a recall. However, their continuing investigation found enough evidence for the FDA to issue an official recall notice the next year in April. They found that the impurities in the drug increased over time, thereby increasing the risk.
In addition to announcing the recall, the FDA has also recommended that anyone still taking Zantac or another drug based on ranitidine stop taking the medication and speak with their doctor about alternative options. The FDA has also stated that medications containing ranitidine have been permanently discontinued and will not return to sales in the U.S. Health experts have advised that people should consult their health practitioners before making changes to their medications but have noted that many alternatives to Zantac (ranitidine) are available for the treatment of heartburn and other stomach disorders. Thus far, other over-the-counter or prescription antacid or ulcer medications have not been affected and remain available as alternatives.
Zantac Cancer Lawsuits
People who have developed stomach, gastric, bladder, kidney, pancreatic, or colon cancer may be considering filing Zantac (ranitidine) cancer lawsuits. Past medical injury lawsuits have provided compensation for medical costs, lost wages, pain and suffering, or wrongful death if a death has occurred.
People who took Zantac (ranitidine) or other formulations or brands containing ranitidine such as Rite Aid or CVS Acid Reducer, Wal-Zan, as a prescription or over-the-counter medication regularly for at least two months and were diagnosed with cancer may be eligible to file a Zantac Cancer Lawsuit and should seek legal advice.