Zantac Side Effects
The link between Zantac and cancer goes back decades. Our firm represents
people from across the country with the following Zantac side effects:
- Bladder cancer
- Brain cancer
- Breast cancer
- Esophageal/nasal/throat cancer
- Kidney cancer
- Liver cancer
- Lung cancer (for non-smokers)
- Pancreatic cancer
- Prostate cancer
- Stomach cancer
- Thyroid cancer
“We have an epidemic of cancer in our society. For years we have
been trying to figure out what’s behind it. Our firm has done a
lot of work exposing the causes of non-Hodgkin lymphoma in our Monsanto
Roundup litigation. Now we have another source of cancer – it appears
that for decades, Zantac has been causing cancer, and we’re only
now just seeing it. People from all across the country have cancer today
because they took Zantac. That is a wrong that we will fight to make right.”
R. Brent Wisner
Common Zantac Brands
Below are some of the most common Zantac brands and generic ranitidine
- Zantac 150 Tablets
- Zantac 150 Maximum Strength
- Zantac 150 Maximum Strength Cool Mint
- Zantac 75 Tablets
- Wal-Zan 150
- Wal-Zan 75
- Heartburn Relief (ranitidine)
- Acid Reducer (ranitidine)
- Acid Control (ranitidine)
Ranitidine and NDMA: What Are the Risks?
U.S. Food and Drug Administration (FDA) announced on September 13, 2019 that it was investigating Zantac cancer risks, after tests of Zantac 150
tablets found the commonly-used heartburn medication contains NDMA at
levels up to 3,000 times greater than the FDA’s daily intake limit.
With countless people now stricken with cancer after taking Zantac, many
are turning to the courts and filing a Zantac lawsuit to hold Sanofi and
Boehringer Ingelheim accountable for their reckless disregard for human
health and willingness to put profit over people.
On April 1, 2020, the FDA also issued an immediate market withdrawal request
of all Zantac (ranitidine) products after determining that NDMA in “some
ranitidine products increases over time and when stored at higher than
room temperatures and may result in consumer exposure to unacceptable
Prior to the FDA market withdrawal of ranitidine, numerous manufacturers
issued generic Zantac recalls on their own, including Apotex, Sandoz (Novartis),
and GlaxoSmithKline (GSK) after Valisure, an online pharmacy that batch
tests the medications it sells, and Emery Pharma, a contract laboratory,
found unacceptably high levels of NDMA in ranitidine during testing. Both
filed citizen’s petitions with the FDA, urging the agency to suspend
sales and issue a Zantac recall. Some versions of Zantac were also recalled
in Canada and Europe.
Central to the Zantac cancer risk issue is the known carcinogen NDMA. N-Nitrosodimethylamine
(NDMA) is a water-soluble organic (containing the element carbon) chemical
and appears as a yellow liquid with little or no obvious taste or odor.
It was once used to make rocket fuel but today is made only for research
purposes. Nevertheless, it can be produced as a byproduct of manufacturing
processes and humans can be exposed to NDMA in relatively small amounts
through a variety of products, including tobacco, foods (cured meat, fish,
cheese, beer), shampoos, cleansers, and pesticides.
World Health Organization NDMA Investigation
The International Agency for Cancer Research (IARC), a unit of the World
Health Organization, is the most recognized cancer research institution
in the world. It brings together teams of scientists from multiple countries
to investigate the cancer-causing potential of suspect chemicals and substances
and publishes papers known as monographs to report the results.
After studying over 200 research papers on NDMA and the NDMA cancer risk,
the IARC placed the chemical in the “Group 2A” category, meaning
substances that are “probably carcinogenic to humans.” The
agency found that NDMA is “carcinogenic in all animal species tested”
and noted that the metabolism of NDMA by humans and animals is similar.
NDMA was found to cause malignant tumor growth in multiple organs, in multiple
species, by multiple routes of exposure (oral, inhalation, subcutaneous
(under the skin), injections), with dose-response relationships appearing
in several studies.Scientists are also gaining detailed knowledge of the
biochemical mechanisms used by the body to repair NDMA DNA damage and
how those mechanisms play a role in the progression towards cancer.
Valisure Study: How Zantac (Ranitidine) Produces NDMA
Recently, multiple generic forms of the blood pressure medication valsartan
have been recalled due to contamination by NDMA and another carcinogen,
N-Nitrosodiethylamine (NDEA). Investigators discovered that the NDMA in
the generics was most likely produced by the actual chemical reactions
that take place when valsartan is made. NDMA was introduced during the
valsartan manufacturing process itself—not added later as a secondary
contamination. This was a consequence of changes in the way valsartan was made.
With Zantac, the source of NDMA appears to be even more dangerous and problematic.
In its initial batch testing of Zantac, which was performed according
to FDA-recommended protocols, Valisure found levels of NDMA reaching as
high as 3,267,968 ng (nanograms) per tablet. The FDA has set the acceptable
daily intake of NDMA at 96 ng, or .096 mcg (micrograms). Valisure was
looking at NDMA levels that were over 34,000 times higher than the FDA limit.
Wondering if the increased heat of the testing process may have contributed
to these results, Valisure decided to test ranitidine in a different way,
under conditions that simulated those found in the stomach (simulated
gastric fluid with sodium nitrite). NDMA levels, while not as high, were
still extraordinary, ranging from 23,600 ng to 304,500 ng, over 3,100
times the FDA’s “safe” limit.
“Valisure’s testing reveals NDMA levels so high that the nitroso
for NDMA likely comes from no other source than the ranitidine molecule
itself.” [Nitroso refers to an atomic grouping of nitrogen and oxygen,
such as found in the nitrite group of NDMA.]
— Valisure Citizen Petition on Ranitidine, September 9, 2019
Valisure also points to a third mechanism that could lead to NDMA production
after Zantac is ingested – an enzyme, dimethylarginine dimethylaminohydrolase
(DDAH), that can react with ranitidine to “liberate” DMA from
ranitidine, making it available to combine with nitrite from the ranitidine
molecule, nitrite circulating in the body, or “other potential pathways
particularly in weak acidic conditions such as that in the kidney or bladder.”
This mechanism, according to Valisure, could generate millions of nanograms
of NDMA throughout the body.
Stanford Study Supports Zantac Cancer Link
Additional evidence of a Zantac cancer link comes from research conducted
by scientists at Stanford University. Their results were published in
2016 in the journal Carcinogenesis. The researchers tested urine samples
from adult volunteers 24 hours before and after ingestion of a standard
dose of 150 mg of ranitidine.
They found that levels of NDMA in the urine increased 400-fold, from 110
ng to 47,600 ng. These levels, the authors wrote, severely underestimate
the actual NDMA exposure in the body, since only a small fraction of the
NDMA is actually excreted in the urine.
Epidemiological Studies of Zantac and Cancer
Very few epidemiological studies of patients taking Zantac have been conducted.
In a study conducted by the National Cancer Institute, adult male health
professionals with peptic ulcers were followed for 14 years (1986 –
2000). The subjects of the study were asked if they used either Tagamet
or Zantac as a treatment. The authors of the study reported that use of
either drug was associated with an increased risk of bladder cancer, though
the increase fell short of statistical significance.
Other Zantac Studies
A true Zantac cancer study in humans—where humans are deliberately
given Zantac to ingest to observe the results—has not been conducted
and never will, as it would be unethical. However, a 1983 study of ranitidine
in rodents found that it produced several “genotoxic effects,”
including DNA fragmentation in the liver and gastric mucosa (the mucous
membrane that lines the stomach). Significantly, studies of Tagamet (cimetidine),
another antacid in Zantac’s class (H2 blockers), did not show DNA damage.
Genetic damage is known to be at the root of all cancers. A 2013 meta-analysis
of studies that examined the relationship between various acid-suppressing
drugs and gastric cancer concluded that that “acid suppressive drugs
are associated with an increased risk of gastric cancer.”
These studies support three important points underlying the danger posed
- NDMA is carcinogenic in humans in exceedingly small amounts.
- Levels of NDMA produced by Zantac are extremely high.
- The problem with Zantac is not an “impurity” in the drug, but
rather the design of the drug itself and how that design makes Zantac
itself a carcinogen.
NDMA has not been directly tested in humans. The cancer risk is too high.
However, we know from years of research that humans are regularly exposed
to NDMA via many foods and beverages. This has provided a means of testing
NDMA’s carcinogenic potential—and by extension the carcinogenicity
of Zantac—in humans indirectly.
Comparing NDMA in Food and Zantac
We should keep in mind that NDMA is carcinogenic even in very small doses.
The U.S. Food and Drug Administration has set the acceptable daily intake
of NDMA at 96 nanograms (ng), or 96 billionths of a gram.
Researchers have reported NDMA levels in food ranging from 14 ng per 100
grams (about 3.5 ounces) in whole milk to 10,900 ng per 100 grams of sausage.
In the studies covered below you will find elevated cancer risks associated
with as little exposure as 179 ng per day. In stark contrast, Valisure,
the pharmacy that sounded the alarm on Zantac, reported that one 150 mg
tablet of ranitidine produced 304,500 ng of NDMA, 1,700 times the exposure
level found to be carcinogenic in some studies.
Which Zantac Brands Have Been Recalled?
To stay as up to date as possible on which Zantac (ranitidine) products
have been recalled, we advise you to consult the FDA’s Recalls,
Market Withdrawals, & Safety Alerts page.
The following companies issued Zantac voluntary (ranitidine) recalls before
the FDA market withdrawal announcement:
- American Health Packaging
- Amneal Pharmaceuticals
- Aurobindo Pharma USA
- Apotex Corp. (this includes over-the-counter ranitidine tablets 75 mg and
150 mg, labeled by Walgreens, Walmart, and Rite-Aid)
- Appco Pharma
- Denton Pharma (dba Northwind Pharmaceuticals)
- Reddy’s Laboratories (this includes Zantac over-the-counter OTC medicines
labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger)
- GlaxoSmithKline (GSK)
- Glenmark Pharmaceuticals
- Golden State Medical Supply
- Lannett Company
- Novitium Pharma
- Perrigo Company
- Precision Dose
Contact us today at (855) 948-5098 for more information on how we can assist you
with filing a Zantac lawsuit.