Zantac

The FDA Requests Zantac and ranitidine be Removed from the Market as Zantac and ranitidine are Linked to Cancer


On April 1, 2020, the FDA requested that all Zantac products be removed from the market immediately because Zantac has been associated with cancer in humans.  This means that if you have taken Zantac (or ranitidine, which is the generic version of Zantac), you have an increased risk of developing many different types of cancer. 

How do I know if I have taken Zantac?

Zantac first came on the market in 1981.  It was the world’s best selling prescription medication by 1987.  Zantac was prescribed by doctors as a treatment for acid reflux, peptic ulcer disease and GERD.  In 1997, the patent on Zantac expired and generic ranitidine hit the market.

Until 2004, you had to have a prescription from your doctor to get Zantac or ranitidine, but beginning in 2004, over-the-counter versions of the medications were approved.  The over-the-counter versions were available at Target, CVS, Rite Aid and any other establishment that sells medication.

The photographs above show the over-the-counter packaging of Zantac. If you remember being prescribed Zantac or remember purchasing one of the above pictured medications to treat acid reflux and have developed cancer, we can help.  Call us for a free consultation.

Keep in mind, there are several other over-the-counter medications to treat acid reflux, such as Nexium and Pepcid.  Those medications have their own problems and have been associated with kidney failure and chronic kidney disease.  If you have taken Nexium or Pepcid and have experienced kidney failure or chronic kidney disease, we can help direct you on how to file a claim for those injuries.  Call us for a free consultation.

What does Zantac treat?

 Zantac is an H2 blocker.  It treats heartburn associated with indigestion and a sour stomach.  Prescription ranitidine was also approved to treat ulcers and GERD.

GERD, or gastroesophageal reflux disease, is a long-term condition in which the acid from your stomach flows back into the tube connecting your mouth and your stomach – your esophagus.  This backwashing effect irritates the lining of your esophagus.  GERD is more than occasional acid reflux – it is a chronic condition.  It can also cause sore throat, difficulty swallowing, a feeling like there is a lump in your throat and can even damage your teeth over time.

According to doctors, there are ways to manage GERD other than taking Zantac.  For example, there are several behaviors that contribute to GERD.  Eating late at night, eating fatty, fried and spicy foods, drinking alcohol and coffee, and taking aspirin are all things that aggravate acid reflux.  Minimizing these behaviors may help.

In addition, there are other over-the-counter medications such as Rolaids, Tums and Mylanta that neutralize stomach acid and may provide relief.  These medications have not been associated with cancer.  Talk to your doctor about safer ways to treat indigestion, acid reflux and GERD.

 Why is Zantac linked to cancer?

  1. The FDA and other independent laboratories have found high levels of NDMA in Zantac.

NDMA, or N-nitrosodimethylamine is a volatile chemical that can develop naturally or unintentionally through the manufacturing process.

Ranitidine, which is the generic name for and active ingredient in Zantac, has a molecular structure that makes it susceptible to naturally creating NDMA in the human stomach once it is ingested.

Recently, an independent lab found high levels of NDMA in Zantac pills it tested.  The FDA then conducted its own testing and found NDMA in both the finished drug product samples it was provided by the makers of Zantac and ranitidine and in the active pharmaceutical ingredients it tested.  As a result of these findings, the FDA recommended that all ranitidine products – including Zantac – be removed from the market.

Several additional laboratories have now found NDMA in Zantac and ranitidine when it is stored over time or when it is exposed to elevated temperatures which would routinely happen during shipment and storage.  The Alameda, an independent lab in California, found the NDMA levels became toxic after ranitidine was exposed to temperatures of 70 degrees Celsius for a period of five days.  Exposure to lower temperatures caused the ranitidine to increase over longer periods of time.

  1. Studies have shown that NDMA is a carcinogen in humans even in small amounts.

NDMA is a known carcinogen in lab animals.  In fact, NDMA has been tested in 12 animal species and was found to cause malignant tumors in all of them.

Many foods contain NDMA or chemicals that make up NDMA.  The “N” in NDMA stands for nitrate and the “A” is Amines.  Most human exposure to NDMA occurs when you eat foods that contain nitrates, nitrites, amines or nitrosamines.  Drinking water also contains low levels of NDMA, as NDMA is a byproduct of industrial processes and water disinfection.  Levels of NDMA in processed foods is typically much, much higher than in drinking water.

We also produce NSMA in our stomachs after eating foods that contain nitrates or nitrites.

Nitrates are often found as preservative additives in cured or smoked meat and in pickled vegetables.  For example, bacon, hot dogs and salami often are high in nitrates.  Nitrates and nitrites are related to each other.  Nitrates can be converted to nitrites by the salivary glands and bacteria – and vice versa. Both can be equally damaging to your health and have been linked to an increased risk of cancer.

After some of the studies showing an increased risk in cancer associated with nitrates and nitrites were made public, consumers demanded bacon and other smoked meat products that did not contain nitrates or nitrites.  Many people have probably noticed that food packaging in their local grocery store has started to include the language “No Nitrates or Nitrites” on the labels of certain foods, for this reason.   Amines are naturally found in many fruits, vegetables, meats and cheeses.  Nitrates and nitrites present in your stomach with amines can form NDMA – the same chemical now found in Zantac.  It is this combination that has been extensively studied in relation to human cancers.

The chemical NDMA has not been tested directly in humans because the risk of cancer is too high.  However, there are many human studies that have been conducted studying cancer risks in people exposed to NDMA in food, as referenced above. Those with diets higher in nitrates and NDMA have shown increased risks of various types of cancer.

One such study was published in 2014, in the British Journal of Nutrition.  The study showed a 40% increased risk in developing colorectal cancer in humans exposed to increased NDMA.  The risk for rectal carcinoma was even higher, at 60%.

This study confirmed the results of a 1999 study in the International Journal of Cancer which showed a significant positive association between NDMA and colorectal cancer with a relative risk between the highest and lowest quantities of exposure of 2.12 (95% confidence interval (1.04-4.33).  That means the group of people who consumed the most NDMA were 200% more likely to develop colorectal cancer than the group who consumed the least.

Other studies have shown increased risks of prostate, brain, gastrointestinal and esophageal cancers.

  1. The levels of NDMA in Zantac are extremely high even when compared to the levels that have been studied in humans who were found to have increased risks of cancer.

It is important to note, the studies discussed above compare the increased risks of cancer in people who ate more foods containing NDMA to people who ate much less food containing NDMA.  These studies do not directly show an increased risk of cancer in people who have taken Zantac.

However, the amount of NDMA in these foods is minimal when compared to the amount of NDMA found in Zantac.  For example, NDMA levels in food range from 14 nanograms in a serving of milk to 10,900 nanograms in a serving of salami.  By contrast, the amount of NDMA found in Zantac is 300,000 nanograms in a single 150mg tablet.

The FDA knows that people are exposed to NDMA through the food we eat.  It has set an “acceptable daily intake limit” of NDMA at 0.096 micrograms or 96 nanograms.  That means the exposure to NDMA through one 150mg Zantac pill is 3,000 times higher than daily levels permitted by the FDA.

 What types of cancer have been linked to Zantac?

Zantac is linked to:

  • Bladder Cancer
  • Colorectal Cancer
  • Esophageal Cancer
  • Intestinal Cancer
  • Kidney Cancer
  • Liver Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Stomach Cancer
  • Testicular Cancer
  • Uterine Cancer

 

If you or your loved one has taken Zantac or ranitidine and developed any of these cancers, please call us today.