On Sept. 13, 2019, the Food and Drug Administration (FDA) first issued a warning about medicines containing ranitidine. Ranitidine, the active ingredient in the heartburn drug Zantac and its generics, was found to cause NDMA to form in the body after ingestion. NDMA is classified as a probable human carcinogen.
On April 2, 2020, the Food and Drug Administration (FDA) recommended removing all prescription and over-the-counter versions of ranitidine, including Zantac and its generics, from store shelves.
The FDA advised companies to recall their ranitidine products if testing showed levels of NDMA above the acceptable daily intake of 96 nanograms per day. In the weeks and months that followed, companies recalled numerous ranitidine products in the U.S.
Furthermore, the older a ranitidine product is, or the longer it sat on store shelves or in a consumer’s medicine cabinet, the greater the level of NDMA. These conditions could cause the levels of NDMA in ranitidine to rise above the acceptable daily intake limit. Exposure to higher temperatures also increases levels of NDMA in the medication.
Ingesting NDMA in low levels isn’t thought to increase the risk of cancer, but sustained higher levels of exposure may increase the risk of cancer in humans.
At least 22 countries, including the United States, Canada, and France, have either removed, stopped sales of, or recalled ranitidine-containing products.
What is Zantac (Ranitidine)?
Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach. The FDA approved over-the-counter ranitidine to prevent and relieve heartburn associated with acid indigestion and sour stomach. Prescription ranitidine received approval for multiple indications, including the treatment and prevention of ulcers of the stomach and intestines and the treatment of Zollinger-Ellison syndrome and gastroesophageal reflux disease (GERD).
Researchers first raised questions about NDMA in Zantac and its link to cancer decades ago, beginning in the 1980s. There is evidence that Zantac makers Sanofi and Boehringer Ingelheim knew about NDMA in Zantac and its link to cancer but covered up this information.
Before the U.S. banned Zantac, about 15 million Americans took prescription-strength ranitidine, and millions more regularly took the antacid over the counter to treat heartburn.
Some generic and brand-name products that contain ranitidine include:
- Zantac 150 mg Tablets
- Zantac 150 mg Maximum Strength
- Zantac 150 mg Maximum Strength Cool Mint
- Zantac 75 mg Tablets
- Wal-Zan 150 mg
- Wal-Zan 75 mg
- Heartburn Relief (ranitidine)
- Acid Reducer (ranitidine)
- Acid Control (ranitidine)
Who makes Zantac?
Zantac was originally made by Pfizer from 2000 to 2006. Sanofi, another pharmaceutical company, is the current maker of Zantac. Many other companies produce the drug under its generic name: Ranitidine.
What is NDMA?
NDMA (N-nitrosodimethylamine) is a known environmental contaminant. The compound is present in water and foods, including meats, dairy products, and vegetables. High levels of NDMA exposure may cause liver damage in humans. Overexposure to NDMA can cause the following symptoms:
- Abdominal cramps
- Enlarged liver
- Reduced function of liver, kidneys, or lungs
NDMA has been found in laboratory research to induce tumors in experimental animals, according to the U.S. National Library of Medicine. In various species, exposure to NDMA has caused tumors primarily in the liver, respiratory tract, kidney, and blood vessels.
Some cancers related to NDMA include the stomach, small intestine, bladder, kidney, colorectal, esophageal, prostate, pancreatic, leukemia, non-Hodgkin’s lymphoma, and multiple myeloma.
The U.S. Environmental Protection Agency (EPA) listed NDMA as a B2 (probable human) carcinogen based on the induction of tumors in rodents and nonrodent mammals exposed to NDMA by various routes.
However, at this point, scientists have published no studies that can identify how great the risk of developing cancer is for someone who has used these drugs, or the specific tumors it may cause.
The FDA considers consuming up to 96 nanograms of NDMA per day reasonably safe for human ingestion, based on lifetime exposure. But, the FDA said, sustained higher levels of exposure [to NDMA] may increase cancer risk in humans.
How was NDMA found in Zantac (Ranitidine)?
Online pharmacy company Valisure conducted routine testing of ranitidine medications and, upon finding elevated levels of NDMA in ranitidine, first alerted the FDA in June 2019. In September 2019, the company provided detailed information in a citizen petition to the FDA, explaining that it had detected levels of NDMA at three million nanograms per tablet, far more than the agency’s permissible daily intake of 96 nanograms.
Valisure said the NDMA was likely due to an inherent instability of the ranitidine molecule. The ranitidine molecule contains both nitrite and dimethylamine (‘DMA’) groups, which are well known to combine to firm NDMA. Valisure called for a recall and suspension of sales of all lots of the products containing ranitidine.
The FDA alerted the public on Sept. 13, 2019. Oct. 2, 2019, the FDA recommended manufacturers use one of two techniques to test their ranitidine products for the presence of NDMA: LC-HRMS and LC-MS/MS. The agency also developed a simulated gastric fluid (SGF) model for use with LC-MS testing to estimate the biological significance of in-vitro findings. Simulated gastric fluid and simulated intestinal fluid models detect the formation of NDMA in systems that approximate the stomach and intestinal fluids.
What Lot Numbers are Included in the Zantac (Ranitidine) Recall?
Dozens of ranitidine manufacturers have recalled their products due to unacceptable levels of the impurity NDMA, a probable human carcinogen. The FDA continues to test the products and update the list of recalled medicines and lot numbers.
Zantac Timeline: FDA Warnings and Recalls
- Sept. 1: FDA issues guidance on N-Nitrosamine impurities in human drugs, providing steps manufacturers of active pharmaceutical ingredients and drug products should take to prevent objectional levels of nitrosamine impurities in pharmaceutical products and describes conditions that may introduce nitrosamine impurities.
- July 13: Several companies recall extended-release metformin products due to NDMA contamination, the same probable cancer-causing impurity found in Zantac.
- May 28: FDA alerts patients and health care professionals to nitrosamine impurities in certain extended-release versions of metformin.
- April 16: Amneal Pharmaceuticals recalls nizatidine oral solution due to NDMA contamination.
- April 1: The FDA issues a Safety Communication calling for the withdrawal of all ranitidine products in the U.S. after finding that levels of NDMA increase to unacceptable levels during certain conditions, such as higher temperatures and longer shelf life.
- Feb. 27: American Health Packaging recalls ranitidine tablets manufactured by Amneal Pharmaceuticals.
- Feb. 3: FDA posts test results on metformin diabetes drugs and finds levels range from not detectable to low levels.
- Jan. 8: Mylan recalls all prescription nizatidine capsules due to the presence of NDMA.
- Jan. 8: Denton Pharma Inc., dba Northwind Pharmaceuticals, an affiliate of Northwind Pharmaceuticals LLC, recalls all unexpired lots of ranitidine tablets.
- Jan. 7: Appco Pharma LLC recalls all quantities and lots of ranitidine hydrochloride capsules.
- Dec. 17: Glenmark Pharmaceutical Inc., USA recalls all unexpired lots of ranitidine tablets.
- Dec. 5: FDA alerts the public of findings of NDMA in diabetes drugs outside the U.S.
- Nov. 19: Percision Dose Inc. recalls five lots of ranitidine oral solution.
- Nov. 15: Golden State Medical Supply Incorporated recalls all lots of ranitidine HCL capsules affected by Novitium Pharma’s recall a month earlier.
- Nov. 12: Amneal Pharmaceuticals LLC recalls dozens of ranitidine syrup oral solution products.
- Nov. 8: American Health Packaging recalls eight lots of ranitidine syrup in response to Lannett Company’s recall. (American Health Packaging had repackaged some Lanett products affected by the recall.)
- Nov. 6: Aurobindo Pharma recalls one lot of ranitidine tablets, 37 lots of ranitidine capsules, and ranitidine syrup
- Oct. 25: Novitium Pharma LLC recalls all quantities and lots of ranitidine hydrochloride capsules.
- Oct. 25: Lannett Company issues a recall of all lots of ranitidine syrup, an oral solution of the heartburn drug.
- Oct. 23: Sanofi, the brand-name Zantac, recalls all Zantac OTC products in the United States.
- Oct. 23: Perrigo Company recalls all pack sizes of ranitidine due to the possible presence of NDMA.
- Oct. 23: Dr. Reddy’s Laboratories recalls 33 lots of ranitidine tablets, including those labeled for Kroger, Target, Walmart, Walgreens, and Sam’s Club.
- Sept. 25: Apotex Corp. recalls 13 lots of generic ranitidine tablets, including those labeled for Rite Aid, Walmart, and Walgreens.
- Sept. 23: Sandoz issued the first Zantac (ranitidine) recall 10 days after the FDA alerted the public about the presence of NDMA in some ranitidine products. It included 14 lots of ranitidine.
Zantac and Cancer
Scientists have found NDMA to induce tumors in experimental animals, according to the U.S. National Library of Medicine. Some cancers that may be related to NDMA include:
- Bladder cancer
- Brain cancer
- Breast cancer
- Colorectal cancer
- Esophageal cancer
- Kidney cancer
- Liver cancer
- Lung cancer (non-smokers)
- Multiple myeloma
- Non-Hodgkin’s lymphoma
- Ovarian cancer
- Pancreatic cancer
- Small intestine cancer
- Stomach cancer
- Testicular cancer
- Thyroid cancer
- Uterine cancer
However, at this point, experts have published no studies that can identify how great the risk of developing cancer is for someone who has used these drugs, or the specific tumors it may cause.
Zantac Multidistrict Litigation
On Feb. 6, 2020, the Judicial Panel on Multidistrict Litigation consolidated several Zantac Cancer lawsuits before federal Judge Robin L. Rosenberg in West Palm Beach, Florida. Since then, more than 400 additional lawsuits have been direct-filed or transferred into the Zantac multidistrict litigation (MDL). The court anticipated that consumers would register thousands more lawsuits in the MDL in the coming months.
Zantac lawsuits claim that Zantac makers Sanofi and Boehringer Ingelheim, knew–or should have known–a cancer causing impurity was present in their products. Still, they failed to disclose this risk to the federal government. The companies also failed to warn consumers that by consuming the ranitidine products, they were at increased risk of developing various life-threatening cancers.
A separate class-action lawsuit accuses Zantac makers of exposing consumers to unsafe levels of NDMA and seeks compensation for the purchase of prescriptions of Zantac and ranitidine products.
Contact a Zantac Lawyer
If you or a loved one were a regular user of Zantac or any other product containing ranitidine and diagnosed with cancer, we would like to talk with you about filing a Zantac lawsuit to get you the compensation you deserve.