FDA orders withdrawal of ranitidine drug from markets

US drug regulator completes seven-month investigation, finds high levels of carcinogen

By DTE Staff
Published: Thursday 02 April 2020

The US Food and Drug Administration (FDA) has found “unacceptable levels” of a cancer- causing agent in ranitidine drugs and has ordered for its immediate withdrawal from the country’s markets.

The impurity of the contaminant, namely, N-Nitrosodimethylamine (NDMA), in ranitidine medications (commonly known by the brand name Zantac) increases over time, especially when stored at higher than room temperatures, the FDA said in a statement on April 1, 2020.

“It may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or over-the-counter (OTC) use in the US,” it said.

Ranitidine is a prescription drug but is also sold over the counter. As an OTC drug, it is used to decrease the volume of acid produced in the stomach. It is also used to prevent and relieve heartburn associated with acid ingestion and sour stomach.

As a prescription drug, it has multiple uses, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease or GERD.

In September 2019, the FDA had found low levels of NDMA in the drug and did not have any specific scientific evidence to say anything conclusive. Therefore, it had just advised citizens to consider other OTC alternatives to ranitidine.

It also announced further investigations. Consequently, India’s drug controller also started testing the presence of NDMA in this drug, in accordance with an order issued in October 2019. The Indian drug regulator did not come up with any results.

“New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions. NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers,” the FDA said.

“The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit,” it added. 

On April 1, the FDA advised consumers to stop consuming OTC ranitidine either in the form of tablets or liquids. Those taking prescription ranitidine were advised to speak to healthcare professionals about other treatment options.

There are several other treatment options — amotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec) — in which the risk of NDMA have not been found. 

“We didn’t observe unacceptable levels of NDMA in many of the ranitidine samples that we tested,” Janet Woodcock, director of the FDA’s Centre for Drug Evaluation and Research, said.

“However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” she added.

Low levels of NDMA are commonly ingested in the diet. It is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer. However, higher levels can lead to many complications. 

Due to the ongoing outbreak of novel coronavirus disease (COVID-19), the FDA recommended that consumers should not insist on taking their stock to a drug take-back location but follow the specific disposal instructions in the medication guide.

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