What Drugs are part of the Zantac / Ranitidine Recall? All forms of Zantac, both in pill form and liquid, both prescription and over-the-counter, have been recalled as of April 1, 2020. This includes ranitidine tablets sold generically. Both Zantac and ranitidine tablets in 75 mg. 125 mg. 150 mg. and 300 mg. dosages have all been recalled. CVS, Rite-Aid, Walgreens, Walmart, and other major retailers pulled Zantac and ranitidine tablets from shelves last winter.
Even so, there was no formal recall from the FDA, and no warnings to consumers to dispose of any Zantac or ranitidine and stop taking the medications until April 1, 2020. Zantac reached sales of $1 billion in 1988, as the best-selling drug of its time, therefore, manufacturers were reluctant to recall the drug until studies showed the drugs were contaminated by NDMA, and that such contamination could lead to harm for consumers. To see a full list of all lots of Zantac and ranitidine recalled, go to https://www.drugs.com/fda-alerts/1991-1283.html.
Who Manufacturers these Drugs? Glaxo Holdings, now GlaxoSmithKline, was the first pharmaceutical company to patent prescription Zantac. Merely five years later, Zantac was a billion dollar a year drug, used to treat ulcers, heartburn, and GERD. When Glaxo’s patent expired in 1997, a number of companies rushed to market generic alternatives to Zantac, with Pfizer receiving FDA approval to sell over-the-counter versions of Zantac in the U.S. Pfizer eventually made a deal with Sanofi, the current manufacturer of Zantac in the United States. Zantac and ranitidine are sold by Johnson & Johnson, Ingelheim Boehringer, Novartis AG, and a number of other major drug manufacturers.
Why were the Drugs Recalled? Zantac and ranitidine were discussed in an FDA safety report last fall, although no recall was mandated at that time. The FDA was testing ranitidine products from multiple manufacturers, assessing the potential impact on patients taking the drug. The agency also asked manufacturers of ranitidine to conduct their own laboratory testing to assess levels of NDMA and asked them to send samples of their ranitidine products to the FDA for testing. The agency then determined that a liquid chromatography mass spectrometry method should be used to detect and quantify NDMA in ranitidine.
The end of October 2019 saw two voluntary recalls of ranitidine—from Dr. Reddy’s Laboratories who sold to retailers such as Kroger, Target, CVS, Walgreens, and Walmart, and Sanofi. In January 2020, Appco Pharma LLC voluntarily recalled prescription ranitidine, and Northwind Pharmaceuticals voluntarily recalled prescription ranitidine manufactured by Glenmark Pharmaceuticals. By the end of February, the FDA alerted consumers and health care professionals that American Health Packaging had issued a voluntary recall of ranitidine tablets due to unacceptable levels of NDMA.
Finally, on April 1, 2020, the FDA sent letters to all manufacturers of Zantac and ranitidine, requesting they withdraw their products from the market immediately. The FDA also advised consumers who were currently taking over-the-counter ranitidine or Zantac to stop taking any liquids or tablets they have, disposing of them properly, and not to buy any more. The FDA told consumers that there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA contamination. To date, the FDA has found no NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) and omeprazole (Prilosec).
What is NDMA and is it Dangerous? Last fall, a statement released by the FDA alerted patients and healthcare professionals of a “probable human carcinogen,” called NDMA, and found in Zantac and ranitidine. NDMA is N-Nitrosamine and is found in several products such as detergents, solvents, and tobacco. NDMA is a yellow liquid produced in the U.S. for use as a research chemical. In the past, NDMA was used in the manufacturing of rocket fuel, however, this use was discontinued when high levels of NDMA were found near rocket fuel manufacturing plants in the air, water, and soil. In some instances, NDMA is unintentionally formed during the manufacturing process as it reacts with other chemicals.
Human exposure can include a diet high in beer, cheese, fish, or cured meats, pesticides, cleansers and detergents, some shampoos and cosmetics, chewing tobacco, and tobacco smoke. Those who work in the fish processing industry, tanneries, pesticide manufacturing plants, dye manufacturing plants, and foundries may have more exposure to NDMA than those who work in other industries. NDMA is particularly harmful to the liver and can cause many different types of cancers because it is a mutagen, causing irreversible DNA changes.
What Types of Cancer Can Result from NDMA Exposure? The cancers seen most often from NDMA exposure include liver cancer, bladder cancer, gastrointestinal and stomach cancers, colorectal cancer, esophageal cancer, intestinal cancer, kidney cancer, lung cancer, testicular cancer, breast, ovarian, and uterine cancers, and pancreatic cancer. The World Health Organization has cited several animal studies that connect NDMA with bladder cancer, and the EPA has evidence from animal studies showing NDMA causes 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.
Are there currently any lawsuits involving these drugs? There are already many lawsuits filed against the manufacturers of Zantac and ranitidine, and it is expected there will be many more in the coming months. It is also likely that many people who were diagnosed with cancer over the past two decades were unlikely to have connected their cancer to their heartburn medication, assuming their medication was safe. Just a few of the most recent lawsuits regarding the NDMA found in Zantac and ranitidine include:
- A California federal class-action lawsuit alleged the manufacturers of Zantac failed to warn users the drug contained NDMA; the Zantac class-action lawsuit, alleges the levels of NDMA in a single Zantac pill far exceeds the acceptable threshold for daily NDMA intake. This ranitidine class action lawsuit states that NDMA is a known cause of liver damage, internal bleeding, and even death.
- Sanofi and other manufacturers are facing a lawsuit filed by a plaintiff who claims he took Zantac for eleven years, then was diagnosed with bladder cancer. The man claims his bladder cancer was a direct result of NDMA exposure from contaminated Zantac. This particular plaintiff is alleging that a single dose of Zantac contains over 3 million nanograms of NDMA—considerably more than the daily allowable limit of 96 nanograms.
- A more recent Zantac class action lawsuit/ranitidine class action lawsuit was filed, claiming the manufacturers of Zantac negligently allowed their products to become contaminated. Plaintiff Dana Viola took Zantac from 2000 through 2016 and is naming Sanofi, the current manufacturer, as well as Pfizer, who held the original patent. Viola claims she and other consumers relied on the representation by Pfizer, which held the heartburn medication was safe and free of defects, however, it contained dangerously high levels of NDMA, making it unfit for human consumption.
Do I have a Zantac Cancer Claim? If you or a loved one has taken Zantac or ranitidine and subsequently were diagnosed with cancer following the Zantac recall, you could benefit from filing a Zantac cancer lawsuit or ranitidine cancer lawsuit. The Zantac cancer risk is very real, due to the NDMA in Zantac and ranitidine. An experienced Zantac attorney can help you determine whether a Zantac cancer lawsuit is right for you. Consider speaking to an experienced Houston Sullo & Sullo Zantac lawyer to determine whether you should file a ranitidine or Zantac lawsuit.