Why the FDA Wants Zantac Off the Shelves

Zantac was a hot topic in the pharmaceutical industry in 2020. It was another case of prescription drugs causing unexpected long-term problems for people who were taking them. Zantac’s active ingredient ranitidine has been linked to a contaminant known to cause cancer in some patients. This is why the FDA has requested the removal of all prescription and over-the-counter ranitidine drugs from the market.

What is Zantac?

Zantac is the most common brand name of ranitidine, which is part of a group of drugs called histamine-2 blockers. These drugs are intended to reduce the stomach acid your body will produce. Ranitidine has many problems and is now suspected to contain N-Nitrosodimethylamine (NDMA), a dangerous contaminant. Zantac is produced by the pharmaceutical giant Sanofi, a French multinational corporation.

Composition

The main active ingredient of Zantac is just ranitidine, commonly appearing or product labels as ranitidine hydrochloride. Ranitidine is the sole active ingredient in Zantac. Other ingredients included inactive binders like magnesium stearate and cellulose. None of the ingredients besides ranitidine have been linked to many health problems.

Uses

Zantac was used to treat peptic ulcers and reduce the risk of ulcers reappearing after treatment. It was also prescribed to treat reflux, also known as GERD. Ranitidine reduces the production of stomach acid that is the root cause of many ulcers and reflux esophagitis.

Zantac was also available over-the-counter as a relief for heartburn and acid-based indigestion. It was also marketed to help with an upset or sour stomach.

The Problems with Zantac

Zantac had multiple problems that stemmed from its ingredients and contaminants.

N-Nitrosodimethylamine

In September of 2019, the compound N-Nitrosodimethylamine (NDMA), which is a known carcinogen, was found in a number of ranitidine products including the brand Zantac. It wasn’t until April 2020 that all ranitidine products were removed from the US and EU markets. NDMA had been found in some drinking water sources in the past, and it was hepatoxic as well as carcinogenic. Hepatoxicity is the quality that causes problems or failure in the liver.

Drug Interactions

Zantac was also well-documented as having negative interactions with many other drugs. Frequently taken over-the-counter medicines like Tylenol (acetaminophen) and even common supplements like Vitamin B12 can have negative interactions with Zantac.

FDA Removal

On April 1st, 2020 the FDA released an official statement requesting that all ranitidine products be withdrawn from the American market immediately. This applied to any product containing ranitidine, not just Zantac, and it also was for both prescription and over-the-counter drugs. The FDA also effectively banned ranitidine from appearing in future products in the United States.

The cited concern was the contamination with NDMA that some researchers have tentatively linked to poor storage conditions. Zantac, when stored at too high of a temperature, was thought to contain more NDMA. Further testing showed that ranitidine had low levels of NDMA even in the best conditioned, and the levels increased over time and poor storage conditions. The levels of NDMA in older Zantac posed a health risk to everyone taking it, so that’s when the FDA called for removal.

What FDA Removal Means for Consumers

It’s too soon to say what the impact of Zantac will be on people that took it. Because the contamination is linked to the storage and age of the product, each consumer will have different circumstances. If you or a loved one took Zantac or another ranitidine product, it would be prudent to consult a doctor and a lawyer.

It’s also too soon to say what a Zantac lawsuit means for impacted consumers, but there are many law firms handling class-action lawsuits related to Zantac and ranitidine. People have been linking the ingestion of Zantac to various cancers like stomach, liver, and bladder cancer. People with a history of stomach acid problems should check their medicine cabinets or receipts for Zantac, stop any use immediately, and consult a professional.