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Banning Zantac: What’s the Legal Trouble with This OTC Medication? – Legal Reader

With cancer claims and amphetamine-related false positives, this drug has a strange history of controversy.
Between commercials, internet articles, and social media advertisements, it seems that where there are drugs, lawsuits are sure to follow. In recent days, this has been the case with an unsuspected drug, Zantac. This over-the-counter (OTC) antacid medication recently made headlines, but how does this relate to other drug dangers? Here’s what you should know about the legal trouble of Zantac and why it matters. 
Rebranding the Zantac Era
When navigating Zantac’s website, visitors are met with the name Zantac 360 and ongoing advertisements for the active ingredient famotidine. This may not seem like anything out of the ordinary, but it turns out that this is an entirely new marketing strategy for an entirely new product. Initially, Zantac was not marketed as Zantac 360, nor did it contain famotidine. Instead, Zantac was simply called Zantac, and it contained the drug ranitidine. This drug was available in prescription and over-the-counter forms, and millions of people in the United States regularly used it. 
However, in September 2019, the Food and Drug Administration (FDA) requested the removal of this drug from the market after tests found a cancer-causing substance among its ingredients. Sanofi, the company that makes Zantac, pulled it off the shelves and later relaunched a new drug under the familiar name but attached “360” to it. 
However, the issue has not been as simple as a mere rebrand with new ingredients. The concern of a carcinogen in the ingredients of Zantac has not remained a theoretical risk. Many people have taken legal action, claiming the drug caused their cancer. In fact, the time between the FDA’s recommendation to remove the drug from shelves to the present day has seen widespread lawsuits spanning numerous states and numerous claims of cancer, including prostate, abdominal and ovarian cancers.

Photo by DESIGNECOLOGIST on UnsplashHowever, on Nov. 7, 2022, the United States Court of Appeals for the Eleventh Circuit, located in Atlanta, dismissed a lawsuit against Zantac’s makers. This was followed by a judgment presented in multidistrict litigation (MDL) on Dec. 6, 2022, when it was found that those suing Zantac’s manufacturers did not provide primary evidence linking their cancer diagnoses to their use of the drug. Litigation is ongoing, and there are plans to appeal previous court rulings But for now, it seems the drug has been relaunched as Zantac 360 with no further consequences.
Other Zantac Controversies
This is not the first time Zantac has been met with controversy. In the years leading up to the removal of the Zantac version containing ranitidine, various people claimed the drug caused false positives of amphetamines during drug testing. Multiple reports were conducted in 2004 and 2015. The conclusion was that while very specific circumstances could cause a false positive for amphetamines, there was not enough evidence to conclude this was anything other than an anomaly. 
With cancer claims and amphetamine-related false positives, this drug has a strange history of controversy. But there is one remaining point to this drug that has more substance. When Zantac contained ranitidine, it increased the absorption rate of alcohol. This effectively increases things like the risk of alcohol overdose and the amount of alcohol in the bloodstream. Zantac changes how the liver processes alcohol and lowers the levels of alcohol required to become intoxicated. 
According to the Centers for Disease Control and Prevention (CDC), alcohol use increases cancer risks, so it may be better to focus Zantac’s risk as a carcinogen on the drug’s secondary effects on alcohol and other substances. It is easy to dismiss this concern since ranitidine has been discontinued. 
Decreasing the Added Risk of Zantac Use
What difference does all this make if Zantac is now Zantac 360 and famotidine has replaced ranitidine? The answer is famotidine carries the same risk of increasing alcohol absorption. This means the concerns related to the increased risk of intoxication, alcohol overdose, and blood alcohol remain with the new version of Zantac. Because of this, it is important to monitor our alcohol use, especially when using drugs such as Zantac 360. 
If you or someone you know has alcohol use disorder (AUD), the best step is to detox from alcohol to decrease the added risk of mixing drugs like famotidine with substances like alcohol.  
Sources:
Zantac OTC. (n.d.). Zantac Homepage. Retrieved https://www.zantacotc.com/en-us/
Harvard Health. (2019, October 1). Popular Heartburn Drug Ranitidine Recalled: What You Need to Know and Do Retrieved https://www.health.harvard.edu/blog/popular-heartburn-drug-ranitidine-recalled-what-you-need-to-know-and-do-2019092817911
Food and Drug Administration. (2020 April 1). FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. Retrieved https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market
Drug Watch. (2022 November 22). Zantac Ranitidine Cancer Lawsuit Dismissed by United States Appeals Court. Retrieved https://www.drugwatch.com/news/2022/11/22/zantac-ranitidine-lawsuit-dismissed/
Reuters. (2022 December 7). Drugmakers’ huge win in consolidated Zantac case shows process can work for defendants. Retrieved https://www.reuters.com/legal/litigation/drugmakers-huge-win-consolidated-zantac-case-shows-process-can-work-defendants-2022-12-07/
National Library of Medicine. (2004 May 25). Interferences in Immunoassay. Retrieved https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1904417/
National Library of Medicine. (2015 January 1). Ranitidine interference with standard amphetamine immunoassay. Retrieved https://pubmed.ncbi.nlm.nih.gov/25242739/
National Library of Medicine. (2000 January). Alcohol Levels Are Increased in Social Drinkers Receiving Ranitidine. Retrieved https://pubmed.ncbi.nlm.nih.gov/10638585/
Centers for Disease Control and Prevention. (2022 January 31). Alcohol and Cancer. Retrieved https://www.cdc.gov/cancer/alcohol/index.htm#:~:text=All%20alcoholic%20drinks%2C%20including%20red,the%20higher%20your%20cancer%20risk.
Medical News Today. (2022 November 22). What to Know About Pepcid and Alcohol. Retrieved https://www.medicalnewstoday.com/articles/pepcid-and-alcohol
Delphi Health Group. (n.d.).Guide to Alcohol Detox: Severity, Dangers, and Timeline. https://delphihealthgroup.com/alcohol/detox/

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