FDA Orders Zantac Removal from Stores

The Food and Drug Administration (FDA) is requesting the immediate removal from the market of all prescription and over-the-counter (OTC) ranitidine drugs, commonly known by the brand name Zantac.

 

The decision is part of an ongoing investigation of the contaminant NDMA (N-Nitrosodimethylamine) in ranitidine medications. NDMA is a probable human carcinogen (a cancer-causing substance). It is known to destroy liver cells and cause cancer in lab animals.

 

FDA and third-party research determined that the impurity in some ranitidine products increased over time. When stored at higher than room temperatures, the contaminant may reach unacceptable levels for consumers.

 

Patients on prescription ranitidine should speak with their doctor about other treatment options before stopping the medicine. Multiple drugs are approved for the same uses as ranitidine that do not carry the same NDMA risks.

 

The FDA advises you to stop taking OTC ranitidine, throw away any tablets or liquid you have, and not buy more. If you wish to continue treating a condition, consider using other approved OTC products.

 

In FDA testing, NDMA has not been found in Pepcid, Tagamet, Nexium, Prevacid, or Prilosec.

 

Low levels of NDMA are commonly present in foods and water and ingested in the diet. These levels would not be expected to lead to increased cancer risk. However, sustained higher levels of exposure may increase the risk of cancer in humans.

 

“The FDA is committed to ensuring that the medicines Americans take are safe and effective,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. [1] “We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science.

 

Woodcock said unacceptable levels of NDMA were not found in “many” of the samples. However, the FDA did not know how long the product had been stored before testing, and quality could not be assured.

 

Additional testing and evaluation confirmed that NDMA levels increase in ranitidine even under normal storage conditions. The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the higher the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.

 

During the COVID-19 pandemic, it is recommended you follow the disposal instructions in the medication guide or package insert. Do not medicines back to a store or drug take-back location.

 

FDA Report: www.fda.gov/medwatch/report.htm

 

 

Citations

 

[1] FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market