Has Zantac/Ranitidine Been Recalled? As of April 1, 2020, the FDA recalled all over-the-counter, and prescription drugs Zantac, as well as any drugs containing ranitidine as a result of the high levels of NDMA found in some of the drug samples. NDMA has been designated as a “probable carcinogen.” The FDA has stated that contamination of Zantac and ranitidine can potentially worsen over time, or when the drug is stored at room temperature. Sanofi voluntarily recalled ranitidine in the United States and Canada months prior to the FDA recall. Manufacturers Sanofi, a French multinational pharmaceutical company and Boehringer Ingelheim, the largest private pharmaceutical, have dealt with the recall of Zantac, which is a product used in the prevention and relief of heartburn.
Zantac was first approved by the FDA in 1983, and only five years later had become the world’s best-selling drug—and one of the first drugs to top $1 billion in annual sales. When Zantac’s patent for ranitidine expired, generic alternatives of the drug were launched across the world. The first time Americans heard about potential NDMA contamination was in 2018 when the blood pressure drug Valsartan was found to have impurities. Later, NDMA was also found in ranitidine samples, and by 2019, the FDA said they had discovered unacceptable levels of NDMA in Zantac and ranitidine. Since that time, a number of cancers have been tied to the NDMA found in Zantac and ranitidine.
What are the Dangers of Zantac/Ranitidine? There have been a number of animal studies that demonstrated the acute, chronic effects of NDMA exposure. Short and medium-term exposures ranging from five days to twelve weeks are associated with negative effects among a variety of species. Other animal studies have shown gastrointestinal hemorrhage and harmful effects in the liver, kidneys, lungs, spleen, and myocardium after several weeks of administration. Ingestion in drinking water and food appears to increase the risk of liver tumors. Nausea, vomiting, abdominal cramps, diarrhea, headache, fever, enlarged liver, and jaundice are all symptoms of severe liver damage from NDMA poisoning.
A 2019 Carcinogenesis study found that NDMA was associated with an increase in the development of pancreatic cancer, as well as potentially causing lung and liver cancers. Some general symptoms of these types of cancers include unintentional weight loss, poor appetite, a change in bowel habits, nausea or vomiting, chronic, severe back pain, fatigue, dizziness, weakness, yellowing of the skin or eyes, dark or bloody urine, and itchy skin. Depending on how long Zantac or ranitidine was taken, as well as the dosage of the drug, serious cancers could result.
What are the Specific Cancers Associated with Zantac/Ranitidine? NDMA is a semi-volatile chemical that can form naturally—or unintentionally via industrial processes. The unintentional formation of NDMA can be a byproduct of the chlorination of wastewater and/or drinking water. While this is believed to be how NDMA came to be found in Valsartan, a blood pressure drug, experts say that the NDMA found in ranitidine is the result of ranitidine, the active ingredient in Zantac, which has a molecular structure that makes it susceptible to creating NDMA.
Ranitidine has both elements required to form NDMA—Nitrite and dimethylamine. Since ranitidine has both these in its chemical structure, the drug can produce NDMA on its own, given the right set of circumstances. A recent independent study combined ranitidine with conditions in the typical human stomach; when the ranitidine interacted with gastric fluids, relatively high amounts of NDMA were produced (304,500 nanograms of NDMA per tablet). Since the FDA has only approved 96 nanograms of NDMA as a “safe” level, there are serious concerns for those who took Zantac or ranitidine for any length of time.
Exposure to NDMA in ranitidine has been linked to a number of cancers, including Non-Hodgkin’s lymphoma, leukemia, pancreatic cancer, prostate cancer, liver cancer, bladder cancer, kidney cancer, esophageal cancer, colorectal cancer, cancer in the small and large intestines, multiple myeloma, and stomach cancer. NDMA is classified as a B2 carcinogen by the EPA, meaning there is not sufficient human data, but there is sufficient animal data to conclude NDMA is a potential carcinogen.
Information on Cancers Associated with Zantac/Ranitidine
- Bladder Cancer—Research has linked NDMA with bladder cancer; a 1993 study done in Spain linked high levels of nitrates in the drinking water with mortality rates from bladder cancer, finding that the mortality rates from bladder cancer in municipalities where the drinking water contained nitrate levels higher than 50 mg/L were 38 percent higher. Many animal studies have shown that NDMA is a strong bladder carcinogen, also increasing the risk of cancerous tumors in the liver, lung, kidney, brain, stomach, and esophagus. The World Health Organization cites several animal studies connecting NDMA with bladder cancer.
- Gastrointestinal and stomach tumors—The Environmental Protection Agency has evidence from animal studies showing nitrosamines like NDMA cause cancer by manipulating certain genes that lead to errors in DNA replication, tumors, and abnormal cell growth, with an increased risk stomach and gastrointestinal tumors in particular.
- Breast Cancer—According to Survivor Net, in December 2019, Florida resident Jill Goldstein filed a lawsuit against four top pharmaceutical companies that manufacture the drug, alleging Zantac caused her breast cancer. While many lawsuits have been filed against manufacturers of ranitidine and Zantac, Goldstein’s is the first to link the drug to breast cancer. Goldstein claims a 2008 peer-reviewed study’ from the Fred Hutchinson Cancer Research Center linked Zantac and breast cancer, with those who regularly took Zantac increasing their risk of developing ductal carcinoma by 240 percent when compared with those who didn’t take Zantac.
- Colorectal Cancer—An NCBI study found a positive association between NDMA and the subsequent occurrence of colorectal cancers.
- Esophageal Cancer—Scientific American found that NDMA at higher levels resulted in liver toxicity in rats and that chronic low doses of NDMA were linked to liver and esophageal tumors in animals.
- Intestinal Cancer—A 2016 NCBI journal article found that NDMA could increase the risk of gastric and intestinal cancers.
- Kidney, Liver, Lung, and Testicular Cancers—While numerous studies have linked NDMA to liver and kidney cancers, a toxicological profile for NDMA found significant increases in lung, liver, and kidney tumors among rats and mice exposed to NDMA for a period of 25 and 17 months, respectively. The same report refers to other studies which showed NDMA primarily targeting the lungs and liver, but also forming tumors in the kidneys and testes.
- Ovarian and Uterine Cancers—Since endocrine-disrupting chemicals can mimic hormones like estrogen and hormonal factors have been found to influence the development of ovarian cancer, NDMA could be a cause of ovarian and uterine cancers as it is an endocrine-disrupting chemical.
- Pancreatic Cancer—A complaint was filed in Ohio by Randy J. Wright in January 2020, naming Boehringer Ingelheim, Sanofi, Chattem, Inc., Pfizer, and GlaxoSmithKline as defendants. Wright stated he began taking Zantac in 1996, using it on a daily basis and was diagnosed with pancreatic cancer in 2019. Wright’s lawsuit states that based on prevailing scientific evidence, exposure to Zantac and the attendant NDMA can cause pancreatic cancer in humans. Pancreatic cancer is relatively rare, and difficult to detect in its early stages because there are few to no symptoms.
- Other Types of Zantac Cancer Death—Because the news of NDMA dangers is relatively new, there may be many more types of cancers linked to the NDMA in Zantac and ranitidine. It is very likely that a significant number of people may have died from cancer that was related to Zantac, but they were unaware at the time of the dangers associated with Zantac NDMA.
What About Death Related to One of These Zantac Cancers? The widow of a West Virginia man has filed a wrongful death lawsuit against the manufacturers of Zantac after he developed esophageal cancer as a result of the NDMA produced by recalled Zantac and ranitidine. Sonja O’Neal filed the complaint on January 10th, 2020, for the 2018 death of her husband, Richard. Richard O’Neal used Zantac on a regular basis from 2003 until his death but was unaware of the dangers associated with Zantac and NDMA at the time since there were no warning labels on the drug. Unfortunately, many consumers remain unaware that a cancer diagnosis or cancer death in recent years could have been directly caused by the NDMA in Zantac and ranitidine. O’Neal’s lawsuit indicates manufacturers of Zantac and ranitidine were likely aware, even before the heartburn drug was first marketed in 1986, of the potential NDMA dangers.
How a Zantac Attorney Can Help with a Zantac Lawsuit or Ranitidine Lawsuit - If you or a loved one developed one of the cancers associated with the NDMA found in Zantac or ranitidine, you could benefit from speaking to an experienced Zantac attorney. At this point, there have been numerous Zantac lawsuits, ranitidine lawsuits, Zantac class-action lawsuits, and ranitidine class-action lawsuits filed, and it is likely there will be many more filed in the coming months. A Zantac lawsuit could potentially reimburse you for the money you have spent on your Zantac cancer, as well as other damages. The Zantac cancer link is clear, due to the NDMA in Zantac. An attorney from Sullo & Sullo can help you determine whether a Zantac cancer lawsuit is right for you.