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In the past few years, the safety of Zantac® and other medications containing ranitidine has come under increased attention. For decades, these products have been widely available in prescription and over-the-counter forms, for the treatment of heartburn and acid reflux, among other common conditions. But a number of consumers (and consumer groups) have filed lawsuits alleging that Zantac®/ranitidine contains dangerous levels of N-nitrosodimethylamine (NDMA), a known carcinogen.
Lab tests have revealed a potential link between the use of ranitidine and the development of cancer, and the U.S. Food and Drug Administration (FDA) has announced a request that manufacturers withdraw all ranitidine drugs (whether prescription or over-the-counter) from the market.
Let's take a look at why the FDA took this significant action in connection with Zantac®/ranitidine, and what it means for current and future litigation over this once-popular medication.
In recent years, the FDA has ramped up its scrutiny of Zantac®/ranitidine, in part based on studies that linked high levels of N-Nitrosodimethylamine (NDMA) with use of these medications. But before April 2020, the FDA's stance was that "the levels of NDMA in ranitidine are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats."
Then came the FDA's April 2020 request that all ranitidine products be pulled from the market. Prior to that FDA announcement, a number of manufacturers of these drugs had voluntarily recalled their products, and some stores (including pharmacies like CVS) had taken ranitidine products off their shelves.
In taking such a decisive step on such a widely-used medication, a big concern of the FDA is that testing showed NDMA levels increasing in ranitidine simply through the passage of time, under optimal storage conditions. So the older the Zantac®/ranitidine product, the more NDMA that was found in it. And when storage conditions involve higher temperatures—"including temperatures the product may be exposed to during distribution and handling by consumers," according to the agency—NDMA levels go up significantly. Read the full April 2020 FDA News Release: FDA Requests Removal of All Ranitidine Products (Zantac) From the Market.
The FDA's market withdrawal recommendation is certainly relevant to any current or future lawsuit over the safety of Zantac®/ranitidine, and could come in handy for the plaintiff (that's the person filing the lawsuit against the ranitidine product manufacturer) when the time comes to prove:
Learn more about how product liability claims like these work.
But the potential link between Zantac®/ranitidine and cancer is relatively new in the decades-long lifespan of these products, and as new evidence has come to light, plenty of precautionary steps have been taken by the manufacturers (including voluntary recalls). So, manufacturers and other defendants might argue that for years there was no reasonable basis to suspect a link between Zantac and cancer, and once a potential connection was found, appropriate remedial action was taken. Bottom line: While the FDA's action is significant, it's not the kind of magic bullet that will automatically decide your case.
If you've been diagnosed with cancer or any other health problem that you think could be related to your use of Zantac® or another ranitidine product, your best first step might be to discuss your situation with an attorney. Learn how to find the right attorney for you and your Zantac®/ranitidine case.