Ranitidine heartburn medications, sold under trade names such as Zantac,contain a compound called NDMA, which may cause cancer in humans. The International Agency for Research on Cancer (IARC) has classified NDMA as “probably carcinogenic to humans.” The EPA also considers NDMA a probable carcinogen, and the WHO has stated that scientific testing indicates that NDMA consumption is positively associated with either gastric or colorectal cancer, and suggests that the human body may be especially sensitive to NDMA and its carcinogenic effects.
Many manufacturers have recalled products containing ranitidine. NDMA has long been used in the research laboratory setting to induce cancer in rats. NDMA, orN-Nitrosodimethylamine, may occur in low or high levels in Zantac, depending on the conditions. Certain factors cause NDMA to be extremely high. For example, when the NDMA in Zantac (or equivalent drugs) is heated, unacceptably high levels of cancer-causing NDMA is produced.
The type of heating that can cause high levels of NDMA include: the time the drugs spend sitting on a shelf in packaging after being analyzed by manufacturers, time spent in a hot car or delivery truck, and even time spent in the body. Zantac did not and does not list any temperature requirements for the drug, including what temperature range at which the drug should be stored or shipped.
Despite the danger, the FDA did not require manufacturers of Zantac and its equivalents to recall the drug. Instead, the FDA merely suggested that manufacturers consider their own recalls. Many drug makers did follow through with recalls, including Sanofi, which is a manufacturer of Zantac. However, some Zantac equivalents / ranitidine products remain on the market.
Affected ranitidine products include:
- Wal-Zan 150
- Wal-Zan 75
- Heartburn Relief (ranitidine)
- Acid Control (ranitidine)
- Acid Reducer (ranitidine)
- Zantac 75
- Zantac Maximum Strength
Valisure, an online pharmacy (“the pharmacy that checks”), initially alerted the FDA in June of 2019 that it had detected concerning levels of NDMA in ranitidine drugs during routine testing. It then filed a citizen petition with the FDA a few months later, stating that it had found “extremely high levels of [NDMA] … in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.” Valisure further claimed that it had detected levels greater than three million nanograms (ng) per tablet – far exceeding the permissible daily intake of NDMA, which is 96 ng.
The FDA questioned the validity of Valisure’s results, stating that the results may have been caused by the high temperatures used during testing. (But see above: high storage temperatures, etc., can cause very high levels of NDMA.) In response to the FDA’s initial comments regarding the validity of its testing, Valisure developed a method of testing that heated samples to 37 degrees (which is body temperature) and mimicked conditions of the stomach (samples were tested in simulated gastric fluid with varying amounts of nitrites (which are found naturally in the body and also in certain foods)). Using this method of testing, there was a lower level of NDMA detected in samples, but the level was still above the permissible daily intake of 96 ng.
NDMA exposure have been linked to various primary cancers, including:
- Stomach
- Colorectal / Colon
- Bladder
- Kidney
- Pancreatic
- Esophageal
- Intestinal
- Liver.
And, in more limited circumstances, NDMA is linked with the following cancers:
- Prostate (early onset)
- Leukemia
- Non-Hodgkin’s Lymphoma
- Multiple Myeloma.
Current Ranitidine and NDMA Investigations
Below is a summary of some of the investigations into ranitidine.
1980s
- Ranitidine is suspected of reacting with nitrite in the stomach to form NDMA.
- Ranitidine is shown to form thousands of ng of NDMA in conditions of the human stomach.
2000s
- Studies show the instability of ranitidine, and its DMA group is linked to forming NDMA in oxidative conditions.
- 40,000 ng of NDMA is found in urine after taking ranitidine pills.
- Urination of ranitidine into wastewater is suspected as a source of NDMA in municipal drinking water.
2004
- A National Cancer Institute study links antacids, ranitidine and cimetidine to bladder cancer.
2016
- A Stanford study indicates that millions of ng of NDMA may be formed by ranitidine separately from the stomach, but the mechanism is unknown.
- Stanford University conducts a clinical study with 10 healthy volunteers taking 150 mg of ranitidine once per day, with results showing > 40,000 ng of NDMA detected in the volunteers’ urine. There is now a suspected link of ranitidine to bladder cancer.
2019
- Valisure shows that ranitidine forms millions of ng of NDMA and can react with itself. Both DMA and nitrite (N) are present in ranitidine.
- N + DMA à NMDA
- Valisure identifies and models DDAH-1 enzyme, revealing a potential mechanism for generating millions of ng of NDMA in body.
- Valisure begins working with Memorial Sloan Kettering Cancer Center on epidemiological studies specific to ranitidine.
Above is just a brief synopsis of some of the information studies regarding ranitidine and NDMA. Manufacturers of ranitidine products knew or should have known that their products could cause high levels of NDMA exposure in patients. As far back as the 1980s, scientific evidence showed that ranitidine exposes users to unsafe levels of NDMA. Throughout the time that ranitidine products – including Zantac – were manufactured, there was an increasing weight of research showing that significant NDMA exposure could result from taking ranitidine products.
Indeed, recent studies have confirmed that the unstable molecules of ranitidine products break down in the digestive tract to create harmful levels of NDMA (especially if the ranitidine comes into contact with nitrites in the digestive tract).
Who May Qualify to File a Ranitidine (Zantac) Lawsuit?
Below are some questions you can ask to help determine if you or a loved one may qualify for a ranitidine cancer lawsuit:
- Were you or a loved one taking a ranitidine product on a regular basis for a minimum of 1 year?
- Are you a non-smoker? If you were a smoker, had you ceased smoking at least 10 years prior to your cancer diagnosis?
- Did you take a ranitidine product at least twice per week for 1 year total?
- Have you or a loved one been diagnosed with any of the above-mentioned cancers?
- Has there been 5 years or less between the time of cessation of ranitidine product use and the diagnosis of cancer?
- Did you have any cancer diagnoses prior to being diagnosed with the cancer you suspect was caused by ranitidine?
Answering “yes” to questions 1-6, and “no” to questions number 7 makes a person a more ideal candidate for filing a ranitidine cancer lawsuit. However, the attorneys at Grewal Law are happy to answer any questions related to these lawsuits.
Dedicated Representation for People Injured by Dangerous Products
As consumers, we invest in products we trust. When a company violates that trust and sells a product that causes illness or injury, victims are left feeling confused, angry, and afraid.
At Grewal Law, PLLC, it is our mission to support victims of unsafe products, especially those that can result in long-term and life-threatening disease. If you or someone you love is suffering from cancer, and you suspect the cancer was caused by a ranitidine product, please contact our award-winning attorneys. We are here to fight for you, and we’ll do everything in our power to recover the compensation you deserve.
If you have any questions about ranitidine product (including Zantac) lawsuits, please call our award-winning attorneys at (888) 211-5798, who are available 24/7 to speak with you. Our consultations are always free.