FDA Orders Removal of Prescription, OTC Ranitidine Drugs

FDA recently announced it has requested that manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.

Last year, FDA became aware of independent laboratory testing that found NDMA in ranitidine, which is otherwise known as Zantac. Low levels are often ingested in a normal diet, but sustained higher levels of exposure could increase the risk of cancer. 

When FDA previously found low levels of NDMA in ranitidine, it didn’t have enough scientific evidence to recommend whether it was dangerous enough for individuals to stop taking their medicine. In September 2019, the agency warned the public of the possible risks and to consider OTC options as a precaution.

Now recent FDA testing has confirmed that NDMA levels increase in ranitidine even under normal storage conditions and the carcinogen was found to increase significantly in samples stored at higher temperatures. 

The agency also found that the older a ranitidine product is, the greater the level of NDMA. Based on these findings, the FDA concluded that the levels of NDMA may increase to levels above the acceptable daily intake limit.

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

“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. 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. The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”

Ranitidine products will not be available for new or existing prescriptions or OTC use in the US.

As part of the announcement today, FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market. FDA is also advising consumers to throw away their current medications and not buy more. OTC prescriptions are a better and safer option, the agency stressed. 

“Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec),” the press release stated.

Additionally, FDA recommended patients and consumers follow specific drug disposal instructions in the medication guide or follow the agency’s recommended steps due to the COVID-19 pandemic.

FDA urges any healthcare professional and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program.

Individuals can complete and submit the report online at www.fda.gov/medwatch/report.htm or download and complete the form and submit it via fax at 1-800-FDA-0178.

“The FDA continues its ongoing review, surveillance, compliance and pharmaceutical quality efforts across every product area, and will continue to work with drug manufacturers to ensure safe, effective and high-quality drugs for the American public,” the press release concluded.