On April 2, 2020, the Food and Drug Administration (FDA) recommended the removal of all prescription and over-the-counter versions of ranitidine, the active ingredient in the heartburn and acid reflux medicine Zantac, as well as generics.
New testing by the agency, as well as an evaluation prompted by information from third-party laboratories, confirmed that the probable human carcinogen N-Nitrosodimethylamine, or NDMA, was present in ranitidine, and that the levels of NDMA increase even under normal storage conditions, and could increase significantly when stored at higher temperatures.
Furthermore, the older a ranitidine product is, or the longer it sat in store shelves or 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.
Ingesting NDMA in low levels isn’t thought to increase the risk of cancer the FDA said. But, “sustained higher levels of exposure may increase the risk of cancer in humans.”
Why was Zantac recalled?
On Sept. 13, 2019, the Food and Drug Administration (FDA) first warned that some medicines containing ranitidine, the active drug ingredient in the heartburn and acid reflux medicine Zantac and generics, was found to cause NDMA, classified as a probable human carcinogen, to form in the body after ingestion.
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, numerous ranitidine products were recalled in the U.S.
FDA testing later revealed traces of NDMA in nizatidine, a similar acid reducer also known by the brand-name prescription drug Axid.
What is (Zantac) ranitidine?
Ranitidine is an H2 (histamine-2) blocker, which works by decreasing the amount of acid created by the stomach. Over-the-counter ranitidine is approved to prevent and relieve heartburn associated with acid indigestion and sour stomach. Prescription ranitidine is approved 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).
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
- April 1, 2020 – 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, 2020 – American Health Packaging recalls ranitidine tablets manufactured by Amneal Pharmaceuticals.
- Jan. 8, 2020 – Mylan recalls all prescription nizatidine capsules due to the presence of NDMA.
- Jan. 8, 2020 – Denton Pharma Inc., dba Northwind Pharmaceuticals, an affiliate of Northwind Pharmaceuticals LLC, recalls all unexpired lots of ranitidine tablets.
- Jan. 7, 2010 – Appco Pharma LLC recalls all quantities and lots of ranitidine hydrochloride capsules.
- Dec. 17, 2019 – Glenmark Pharmaceutical Inc., USA recalls all unexpired lots of ranitidine tablets.
- Nov. 19, 2019 – Percision Dose Inc. recalls five lots of ranitidine oral solution.
- Nov. 15, 2019 – Golden State Medical Supply Incorporated recalls all lots of ranitidine HCL capsules, which were affected by Novitium Pharma’s recall a month earlier.
- Nov. 12, 2019 – Amneal Pharmaceuticals LLC, recalls dozens of ranitidine syrup oral solution products
- Nov. 8, 2019 – 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, 2019 – Aurobindo Pharma recalls one lot of ranitidine tablets, 37 lots of ranitidine capsules and ranitidine syrup
- Oct. 25, 2019 – Novitium Pharma LLC recalls all quantities and lots of ranitidine hydrochloride capsules.
- Oct. 25, 2019 – Lannett Company issues a recall of all lots of ranitidine syrup, an oral solution of the heartburn drug.
- Oct. 23, 2019 – Sanofi, maker of brand-name Zantac, recalls all Zantac OTC products in the United States.
- Oct. 23, 2019 – Perrigo Company recalls all pack sizes of ranitidine due to the possible presence of NDMA.
- Oct. 23, 2019 – Dr. Reddy’s Laboratories recalls 33 lots of ranitidine tablets, including those labeled for Kroger, Target, Walmart, Walgreens, and Sam’s Club.
- Sept. 25, 2019 – Apotex Corp. recalls 13 lots of generic ranitidine tablets, including those labeled for Rite Aid, Walmart, and Walgreens.
- Sept. 23, 2019 – The first Zantac (ranitidine) recall was issued by Sandoz 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
According to David Light, CEO of Valisure, the online pharmacy that detected the unacceptable levels of NDMA in ranitidine, consumers who have used ranitidine products contaminated with NDMA have cause for concern, especially those who used the products more frequently or for a longer period of time.
Light told WebMD that, “The damage would be less if you’re an occasional user, but it’s cumulative.” Light is working with researchers at Memorial Sloan Kettering Cancer Center to better understand the cancer risk ranitidine poses to humans.
What is NDMA?
NDMA (N-nitrosodimethylamine) is a known environmental contaminant. It is found in water and foods, including meats, dairy products, and vegetables. According to the FDA, consuming up to 96 nanograms of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure. But, the FDA said, “sustained higher levels of exposure [to NDMA] may increase the risk of cancer in humans.”
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.
How was NDMA found in Zantac (ranitidine)?
The FDA alerted the public 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 – the LC-HRMS method and the LC-MC/MS method. The agency also developed a simulated gastric fluid (SGF) model to be used with the LC-MS testing method to estimate biological significance of in vitro findings. The simulated gastric fluid and simulated intestinal fluid models are intended to detect the formation of NDMA in systems that approximate the stomach and intestinal fluids.
NDMA has been found “in laboratory research to induce tumors in experimental animals,” according to the U.S. National Library of Medicine. Some cancers that may be related to NDMA include stomach, small intestine, bladder, kidney, colorectal, esophageal, prostate, pancreatic, leukemia, non-Hodgkin’s lymphoma, and multiple myeloma.
However, at this point, no studies have been published 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.
Attorneys with Beasley Allen Law Firm are currently investigating claims of those who have used Zantac, which was voluntarily recalled from the market on Sept. 13, 2019, and has been linked to certain types of cancer, including liver, bladder, stomach, colon, kidney and pancreatic cancer.
Zantac is used to treat and prevent ulcers in the stomach and intestines. It also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome, gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.
If you or a loved one was a regular user of Zantac or any other product containing ranitidine and have been diagnosed with cancer, we would like to talk with you. Contact Frank Woodson, one of our leading pharmaceutical attorneys in charge of Zantac cancer claims.