Craig Rosenbaum | April 7, 2020 | Defective Drugs
New FDA Announcement Calls for Zantac to be Pulled from Market
The popular heartburn medication Zantac (ranitidine) was recalled and taken off shelves in September of 2019 after the Food and Drug Administration announced that it had found the cancer-causing chemical N-nitrosodimethylamine (NDMA) in samples of Zantac. The FDA has recently taken further action, announcing on April 1, 2020, that they have requested all manufacturers to withdraw all Zantac and generic Zantac OTC ranitidine drugs from the market effective immediately.
The FDA stated that an ongoing investigation has determined that levels of NDMA in the medicine has increased over time and when it is stored at higher-than-normal temperatures, it creates a risk to public health. As part of the FDA’s announcement, they have advised consumers of the drug to properly dispose of their medications and to not buy more. Due to the coronavirus pandemic, the FDA has posted safe disposal steps on its website and has advised to follow these steps rather than returning the medicine to the “drug take-back location.”
In January, the FDA had announced that two companies were voluntarily recalling their ranitidine medications. Appco Pharma LLC voluntarily recalled prescription ranitidine hydrochloride capsules in the first week of January, while Northwind Pharmaceuticals voluntarily recalled prescription ranitidine tablets manufactured by Glenmark Pharmaceutical Inc. on January 6, 2020. This came on the heels of large drug stores such as CVS and Walgreens announcing that they would no longer be selling Zantac or other ranitidine medications.
What is Zantac?
Zantac is the popular trade name for Ranitidine, a medication that reduces the body’s production of stomach acid. Zantac belongs to a class of drugs called histamine H2-receptor antagonists (or H2 blockers), which decreases the amount of stomach acid the body produces.
Zantac is a very popular antacid medication that has been on the market since the early 1980’s. Zantac is available over the counter (Zantac OTC) and by prescription. People commonly use Zantac for acid reflux, heartburn, and a host of other stomach, throat, and gastrointestinal issues. Prescription strength Zantac is also available to treat and prevent more serious ulcers in the stomach and intestines.
What is NDMA and What Harm Can It Cause?
NDMA is an environmental contaminant that is found in water and foods, including dairy products, vegetables, and grilled meats. Its classification as a probable carcinogen is based on studies in animals, as studies in humans are still developing.
The FDA was made aware in September of 2019 some ranitidine medicines, including Zantac, contained NDMA. The EPA classified NDMA as “extremely hazardous,” and there are strict reporting requirements for companies and individuals who produce, store, or use NDMA in large quantities. To date, the FDA has not found NDMA in some other products, such as famotidine, or Pepcid, esomeprazole or Nexium, or omeprazole or Prilosec.
Independent testing conducted by the online pharmacy Valisure has revealed that levels of NDMA in one Zantac 150mg tablet may exceed 3,000,000 nanograms (ng), which is 26,000 times higher than the FDA’s permissible daily intake for the chemical. The FDA’s recommendations limit the daily intake for NDMA to 96 ng, but users taking the 150- daily dose of Zantac are exposed to 889,000,000 ng of NDMA over the course of a year. Excessive levels were detected across all brands of Zantac, and Valisure’s studies have indicated that there have been potential warning signs for the presence of NDMA dating back 20 years.
NDMA exposure has been linked to various primary cancers including: stomach, small intestine, colorectal, esophageal, and liver. These have been grouped as the “Tier 1” of most likely cancers, with stomach cancer being the most frequent. In more limited circumstances, exposure to NDMA has also been linked to: early onset prostate cancer, pancreatic cancer, leukemia, non-Hodgkin’s lymphoma, and multiple myeloma. While these “Tier 2” cancers are not as frequent due to NDMA exposure, they are still a possible result.
Plaintiffs have recently come together to file a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federally filed Zantac lawsuits into one court for pre-trial proceedings. All legal proceedings for the multidistrict litigation (MDL) will take place in the U.S. District Court for the Southern District of Florida.
The defendant drug companies initially sought to centralize the MDL in other courts, including New Jersey, where Zantac distributor Sanofi is headquartered. However, the court noted that because most plaintiffs appeared to have coalesced around the Southern District of Florida as their first choice for the transferee district, the proceedings will continue there. U.S. District Judge Robin Rosenberg will preside over the new MDL, No. 2924, which is Judge Rosenberg’s first time overseeing an MDL. Once discovery is complete, the judge may select several individual lawsuits to proceed as bellwether trials. These initial trials help both sides predict how other suits in the MDL may fare. For example, if drug companies lose most of the bellwether trials, they may reach a global settlement with consumers more quickly.