Zantac, a heartburn drug made by Glaxo-Smith-Kline, Pfizer, Boehringer Ingelheim, and Sanofi, was used to decrease stomach acid. People suffering from gastroesophageal reflux disease, peptic ulcer, or Zollinger-Ellison syndrome took the drug by mouth or injection.
But in April 2020, the U.S. Food and Drug Administration (FDA) recalled Zantac, both over-the-counter (OTC) and prescription versions in the U.S., while sales were suspended in the European Union and Australia.
The problem with Zantac – it was found to contain NDMA, a known carcinogen.
Just before it was recalled, after more than 13 million prescriptions were issued, Zantac was the 53rd most commonly prescribed medication in the U.S.
The class of medication is ranitidine, and the problem is when exposed to heat, Zantac breaks down, forming NDMA (N-Nitrosodimethylamine) or N-nitrosamine. These are formed when a second or third amine reacts with a nitrosating agent.
N-nitrosamines are present in low levels in cured meats such as bacon, fermented foods, such as beer and cheese, even shampoo, and cleansers.
FDA Recall
In announcing the recall, the FDA said NDMA could increase in some ranitidine products over time, even when stored in standard room temperatures. The acceptable daily intake limit of NDMA is 96 nanograms per day, according to the agency.
Stores received letters from the FDA to withdraw their products from the shelves while consumers were advised to stop taking a ranitidine product, whether tablets or liquid, dispose of them properly, and not buy more.
Other drugs are approved for the same use as ranitidine without the same risks from NDMA, such as Pepcid, Tagamet, Nexium, Prevacid, and Prilosec.
It should be noted that Zantac 360 is not part of the recall. The company relaunched Zantac with a new name, Zantac 360, and a new ingredient, famotidine.
Because of NDMA contamination, another heartburn medication, Nizatidine, was recalled in January 2020 by manufacturer Mylan. Metformin, the diabetes drug taken by nearly 16 million people, has been found to contain NDMA and the FDA requested five firms recall their products.
The FDA has a list of 170 products recalled since May 2020 because they contain metformin.
While no one is certain how NDMA gets into the products, the contamination may come from recycled solvents used in manufacturing, the breakdown of unstable compounds, or a side reaction from drug syntheses. The source can be the manufacturing process, storage, and packaging.
Because ranitidine is an unstable drug, over time, the molecule degrades to form NDMA.
The Investigation
In the summer of 2019, the FDA became aware of an independent lab finding of NDMA in ranitidine.
Some food and water, including smoked and cured meats and air pollution, contain NDMA, but those lower levels are not linked to an increased risk of cancer, resulting from a sustained higher and cumulative exposure.
In 2019 the FDA did not have enough data to suspend sales of Zantac. It was determined the levels found of NDMA were very low but by September 2019, the agency was ready to warn the public of the potential risks.
The story got even worse as further testing uncovered that NDMA levels increased under normal storage conditions. The unknown is the temperature exposure during distribution, shipping, and handling by consumers.
Regardless, data showed the older a ranitidine product, the greater level of NDMA, in a level above the acceptable daily limit.
Cancer Risk
Zantac was on the market for 40 years and was approved for use in over 31 countries.
It was first approved in 1983 after a petition from its manufacturer Glaxo Holdings Ltd, a company part of GlaxoSmithKline PLC. Zantac was initially approved for the short-term treatment of ulcers.
Later it became popular for the treatment of gastroesophageal reflux disease (GERD).
Millions of patients have taken Zantac over the years.
Types of cancer include:
- Breast cancer
- Kidney cancer
- Liver Cancer
- Esophageal cancer
- Colorectal cancer
- Bladder cancer
- Intestinal cancer
- Lung cancer
- Ovarian cancer
- Pancreatic cancer
- Prostate cancer
- Stomach cancer
- Testicular cancer
- Thyroid cancer
- Uterine cancer
Zantac Litigation
An MDL was consolidated in the Southern District of Florida, the Zantac (Ranitidine) Products Liability Litigation February 6, 2020 (MDL 2924) before Judge Robin L. Rosenberg. There are 1,573 pending cases as of October 15, 2021. Originally 1,619 were filed.
Plaintiffs who took the drug and later developed cancer seek compensation for pain, suffering, financial losses, medical bills, and loss of a loved one. They contend the drug is defectively designed, and the Zantac drug label failed to warn about cancer risks.
Plaintiffs claim they had no family history of cancer or any genetic markers. In some cases, patients taking Zantac also were diagnosed with Chron’s disease and primary pulmonary hypertension (PPH).
Plaintiffs taking Zantac for at least a year have a stronger case.
The Zantac MDL is currently in the final stages of depositions, concluded before expert reports and the bellwether trials. To date, there have been no trials concerning Zantac.
Several class actions are proposed in New Jersey, Florida, California, Connecticut, and Massachusetts. These class actions only require the plaintiff to have purchased the drug and do not relate to a cancer diagnosis.
Plaintiffs in those class actions can seek a refund for the purchase of the Zantac products.
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Sources:
Clincalc.com
https://clincalc.com/DrugStats/Drugs/Ranitidine
TGA.gov.au
https://www.tga.gov.au/alert/ranitidine-0
FDA recalled metformin products
https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-metformin-products
JPML
https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-October-15-2021.pdf
Good RX
https://www.goodrx.com/blog/zantac-new-version-famotidine/