The announcement is in response to ongoing reports of contamination with N-Nitrosodimethylamine (NDMA).
In response to ongoing reports of contamination with N-Nitrosodimethylamine (NDMA), the FDA is requesting all US manufacturers to remove both prescription and OTC ranitidine (Zantac) drugs from the market immediately.
NDMA is a probable human carcinogen. Low levels are often ingested in a normal diet, but sustained higher levels of exposure could increase the risk of cancer, according to the FDA. In a statement, the FDA said they became aware of NDMA contamination in ranitidine products found by independent laboratory testing.
Although the statement said the agency did not have enough scientific evidence to make a recommendation at the time, researchers continued testing. The FDA warned the public in September 2019 of the potential risks and recommended considering alternative OTC and prescription products.
Now, new FDA testing has confirmed that NDMA levels increase in ranitidine even under normal storage conditions and the carcinogen has been found to increase significantly in samples stored at higher temperatures. They 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.
Patients currently taking prescription ranitidine should speak with their prescriber about other options before stopping the medication. A press release from the FDA noted that there are multiple approved drugs for the same or similar uses, without the same risks from NDMA. Currently, the FDA has not found NDMA in famotidine, cimetidine, esomeprazole, lansoprazole, or omeprazole.
Patients on OTC ranitidine medications should stop taking any tablets or liquids they currently have, dispose of them properly, and should not buy more, according to the FDA statement.
In light of the coronavirus disease 2019 (COVID-19) pandemic, the FDA recommends that patients should follow specific disposal medications in the medication guide or package insert rather than taking their medications to a drug take-back location.
The FDA is sending letters to all manufacturers requesting the withdrawals.
“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” said Janet Woodcock, MD, director of the Center for Drug Evaluation and Research, in a statement. “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.”
FDA Requests Removal of All Ranitidine Products (Zantac) from the Market [news release]. FDA; April 1, 2020. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market. Accessed April 1, 2020.