Zantac is the well-known brand name for an oral medication that has been used to treat and prevent conditions affiliated with the excess production of stomach acid, such as: heartburn, ulcers and common inflammations of the esophagus like Gastro-Esophageal Reflux Disease (GERD).  Part of a family of drugs known as H2-blockers, Zantac was, until recently, available both as an over-the-counter (OTC) and prescription medication.  In September 2019, the Food and Drug Administration (FDA) issued a statement alerting the public and physicians that Zantac and some of its generic equivalents contained a probable carcinogen.  This statement was followed up on April 1, 2020, with a request from the FDA that manufacturers withdraw Zantac and generic equivalents from store shelves completely.

Prescription Name and Overview

Zantac is the product name for the drug ranitidine.  It was available both in prescription form as well as OTC and is generally consumed in oral dosages for the treatment and relief of ulcers in the stomach and intestines, as well as esophageal and somach ailments.  It is part of a family or class of drugs like Tagamet (cimeltadine), Axid (nizatidine) and Pepcid (famotidine) which are known as “H2-Blockers” for their method of action in blocking the action of histamine in cells in the stomach.  Although Zantac was one of the best-selling drugs in history and a huge source of prestige and revenue for its manufacturer, GlaxoSmithKline (in the United Kingdom) and Sanofi (in the United States), profits from sales of Zantac and its generic equivalents took a massive hit in 2019 when the FDA issued a warning concerning the presence of N-nitrosodimethlamine (NDMA), a probable human carcinogen in laboratory settings.  The FDA warning was amplified in April 2020 with a total recall of all prescription and OTC ranitidine products from the U.S. market pursuant to its ongoing investigation over the presence of NDMA contaimination of Zantac and some of its generic equivalents.

Generic Name and Overview

Therapeutic equivalents are/were marketed under the drug name Ranitidine.

OTC  Name and Overview

Manufacturer

Zantac (ranitidine)

Sanofi, S.A./Sanofi-U.S. (United States)

Labeled Indications

FDA-approved uses include the treatment of duodenal and gastic ulcers, GERD, and erosive esphagitis which have been diagnosed through endscopy.  Zantac is also approved for the treatment of Zoellinger-Ellison syndrome, which causes excess production of stomach acid.  Zantac was determined suitable for both short-term and long-term use dependent upon dosage.

Dosages

Active Duodenal Ulcer

150mg Twice Dailiy or 300mg Once Daily After Evening Meal

Zollinger-Ellison Syndrome and Other Pathalogical Hypersecretory Conditions

150mg Twice Daily

Benign Gastic Ulcer

150mg Twice Daily

GERD

150mg Twice Daily

Erosive Esophagitis

150mg Four Times Daily

What Is It Used For?

Zantac is usd to trreat ulcers all along the intestinal tract and then prevent their return following treatment and healing.  In its OTC form Zantac is commonly used to treat heartburn and related symtpoms stemming from too much acid production in the stomach.

How Does it Work?

Zantac belongs to a family of drugs which are referred to as “H2-Blockers”or “histamine receptor antagonists”.  Histamine is a naturally occuring chemical in the human body that acts upon receptors in the cells of the stomach which triggers the production of stomach acid during the process of digestion.  It works to block H2 receptors in the cells lining the stomach, and causes them to produce less stomach acid.  Zantac also helps to relieve pressue and symptoms from indigestion caused by excess stomach acid and reduces backflow of acid into the esophagus.  Finally, the H2 blocking action allows peptic ulcers time to heal by reducing the amount of acid in the stomach and duodenum.

What are the Approved Uses?

It is approved for treating and preventing ulcers in the duodenum and stomach.  It is also used for treating heartburn, erosive esophagitis and Zoeller-Ellison syndrome.

Production Anecdotes / History

First approved by the FDA in 1984, Zantac was the second H2-Blocker approved for the U.S. market.  Upon approval, it began a decades-long climb to dominate the market for ulcer, heartburn and acid indigestion treatments which made it one of the best selling drugs in history.  Zantac was initially developed by GlaxoSmithKline (GSK) to match the success of another H2-Blocker, Tagamet.  Through a well-documented approach modifying existing drug technology, GSK was able to fashion Zantac as a Tagamet alternative with improved tolerability, longer lasting action and fewer issues with intolerance.  Since reaching its peak in market-share in 1988, Zantac has since been largely superceded by the introduction of Proton Pump Inhibitors (PPIs), such as Priolesc (omeprazole), into the marketplace.

In September 2019, the FDA first announced that Zantac and some of its generic equivalents had been found to be contaminated with NDMA, a probable human carcinogen.  At the same time, regulators in Canada announced that companies there would cease marketing Zantac and its generic equivalents until evidence surfaces that its level of NDMA contamination is not unacceptable.  Other manufacturers of generic equivalents in the U.S. followed suit with voluntary recalls of their products and on April 1, 2020, the FDA announed a mandatory withdrawal of prescription and OTC Zantac and generic equivalents from store and pharmacy shelves throughout the United States.